Hepatocellular CarcinomaPhase 2NCT04401800
Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma
A Phase 2 study testing Lenvatinib and Tislelizumab in people with Hepatocellular Carcinoma and Unresectable Hepatocellular Carcinoma, run by BeiGene at 9 sites in China.
Trial summary
The primary objective of this study was to assess the preliminary antitumor activity as indicated by overall response rate (ORR) of tislelizumab in combination with lenvatinib in participants with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC) by central site imaging facility per Response… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma, Metastatic Hepatocellular Carcinoma
- What is being tested?
- Lenvatinib and Tislelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 9 sitesChina
- Study dates
- 4 Sep 2020to 18 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments
- Unresectable locally advanced or metastatic HCC, which must be confirmed by histologically or cytologically. Fibrolamellar, sarcomatoid, or mixed cholangiocarcinoma histology confirmed by histologically or cytologically is excluded.
- Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease that is not amenable to or has progressed after loco-regional therapy and is not amenable to a curative treatment approach
- Did not receive any systemic treatment before and is unwilling to accept standard of care treatment or not suitable for standard of care treatment as judged by investigators
- At least 1 measurable lesion as defined by RECIST v1.1
- European Cancer Oncology Group (ECOG) Performance Status ≤ 1
- Child-Pugh A classification for liver function assessed within 7 days of first dose of study drugs
Who cannot join
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Any active malignancy ≤ 2 years before the first dose of study drugs except for specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)
- Uncontrolled diabetes or > Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management, or ≥ Grade 3 hypoalbuminemia ≤ 14 days before the first dose of study drugs
- Any known brain or leptomeningeal metastases
- Concurrent participation in another therapeutic clinical study
- NOT: Other protocol defined Inclusion/Exclusion criteria may apply NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, 510060
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
Zhejiang University College of Medicine Second Affiliated Hospital
Hangzhou, Zhejiang, 310009
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
Anhui Provincial Hospital
Hefei, Anhui, 230000
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
About this study
Official title: A Phase 2 Study to Investigate the Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib in Patients With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma
The primary objective of this study was to assess the preliminary antitumor activity as indicated by overall response rate (ORR) of tislelizumab in combination with lenvatinib in participants with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC) by central site imaging facility per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Conditions
- Hepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma, Metastatic Hepatocellular Carcinoma
- Being tested
- Lenvatinib, Tislelizumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenvatinibDrug
Capsules administered orally once daily
TislelizumabDrug
200 mg intravenous (IV) infusion administered on Day 1 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| Lenvatinib With Tislelizumab | Experimental | Participants received lenvatinib based on baseline weight (12 milligrams [mg] or 8 mg once daily for participants with a baseline weight of >= 60 kilograms [kg] or < 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. Receives: Drug: Lenvatinib; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) as Assessed by Central Imaging Facility Based on RECIST v1.1
ORR was defined as the percentage of participants achieving the best overall response (BOR) of complete response (CR) or partial response (PR). The 95% confidence interval (CI) was estimated using the Clopper-Pearson method. Per Response evaluation criteria in solid tumors (RECIST) version (v)1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months
Secondary outcomes (19)
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Treatment Discontinuation and Modification
A TEAE was defined as adverse event (AE) that had an onset date or a worsening in severity from baseline (pre-treatment) on or after the first dose of study drug(s) and up to 30 days following study drug(s) discontinuation or initiation of new anticancer therapy, whichever occurs first determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. SAE: any untoward medical occurrence at any dose: resulted in death; was life threatening; required prolong inpatient hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect or was considered a significant medical event by the investigator.
Measured: From the date of the first dose of study drug up to 30 days after last dose of study drug (maximum time on treatment was 12 months)
Objective Response Rate (ORR) as Assessed by the Investigator Based on RECIST v1.1
ORR was defined as the percentage of participants achieving the BOR of CR or PR. The 95% CI was estimated using the Clopper-Pearson method. Per RECIST v1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; i.e., up to 27 months
Objective Response Rate (ORR) as Assessed by the Investigator and Central Site Imaging Facility Based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
ORR was defined as the percentage of participants achieving the BOR of CR or PR. The 95% CI was estimated using the Clopper-Pearson method. Per modified RECIST (mRECIST), CR was defined as the disappearance of any intratumoral arterial enhancement in all target lesions. PR: at least a 30% decrease in the sum of diameters of viable (contrast enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions.
Measured: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months
Objective Response Rate (ORR) as Assessed by the Investigator and Central Site Imaging Facility Based on Immune Related Response Evaluation Criteria in Solid Tumors (iRECIST)
ORR was defined as the percentage of participants achieving the BOR of immune complete response (iCR) or partial response (iPR). The 95% CI was estimated using the Clopper-Pearson method. Per iRECIST, iCR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. iRECIST is a modification to RECIST that considers unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression.
Measured: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months
Duration of Response (DOR) As Assessed by The Investigator Based on RECIST v1.1
DOR was defined as the time interval between the date of the earliest qualifying response (CR or PR) and the date of PD or death (whichever occurred earlier). DOR was estimated using the Kaplan-Meier method. Per RECIST v1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Measured: From the date of earliest response to the date of first documentation of disease progression or death, whichever occurred first (up to 35 months)
Duration of Response (DOR) As Assessed by The Central Site Imaging Facility Based on RECIST v1.1
DOR was defined as the time interval between the date of the earliest qualifying response (CR or PR) and the date of PD or death (whichever occurred earlier). DOR was estimated using the Kaplan-Meier method. Per RECIST v1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Measured: From the date of earliest response to the date of first documentation of disease progression or death, whichever occurred first (up to 35 months)
Duration of Response (DOR) As Assessed by The Investigator Based on mRECIST
DOR was defined as the time interval between the date of the earliest qualifying response (CR or PR) and the date of PD or death (whichever occurs earlier). DOR was estimated using the Kaplan-Meier method. Per mRECIST, CR was defined as the disappearance of any intratumoral arterial enhancement in all target lesions. PR: at least a 30% decrease in the sum of diameters of viable (contrast enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions. PD: an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since the treatment started.
Measured: From the date of earliest response to the date of first documentation of disease progression or death, whichever occurred first (up to 35 months)
Duration of Response (DOR) As Assessed by the Central Site Imaging Facility Based on mRECIST
DOR was defined as the time interval between the date of the earliest qualifying response (CR or PR) and the date of PD or death (whichever occurs earlier). DOR was estimated using the Kaplan-Meier method. Per mRECIST, CR was defined as the disappearance of any intratumoral arterial enhancement in all target lesions. PR: at least a 30% decrease in the sum of diameters of viable (contrast enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions. PD: an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since the treatment started.
Measured: From the date of earliest response to the date of first documentation of disease progression or death, whichever occurred first (up to 35 months)
Duration of Response (DOR) As Assessed by The Investigator Based on iRECIST
DOR was defined as the time interval between the date of the earliest qualifying response (iCR or iPR) and the date of confirmed progressive disease (iCPD) or death (whichever occurs earlier). DOR was estimated using the Kaplan-Meier method. Per iRECIST, iCR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. iRECIST is a modification to RECIST that considers unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression.
Measured: From the date of earliest response to the date of first documentation of disease progression or death, whichever occurred first (up to 35 months)
Duration of Response (DOR) As Assessed by The Central Site Imaging Facility Based on iRECIST
DOR was defined as the time interval between the date of the earliest qualifying response (iCR or iPR) and the date of confirmed progressive disease (iCPD) or death (whichever occurs earlier). DOR was estimated using the Kaplan-Meier method. Per iRECIST, iCR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. iRECIST is a modification to RECIST that considers unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression.
Measured: From the date of earliest response to the date of first documentation of disease progression or death, whichever occurs first (up to 35 months)
Disease Control Rate (DCR) As Assessed by The Investigator and Central Site Imaging Facility Based on RECIST v1.1
DCR was defined as the percentage of participants with BOR of CR, PR or SD. Participants without post-baseline tumor assessment were considered as failure in DCR. The 95% CI was estimated using the Clopper-Pearson method. Per RECIST v1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months
Disease Control Rate (DCR) As Assessed by The Investigator and Central Site Imaging Facility Based on mRECIST
DCR was defined as the percentage of participants with BOR of CR, PR or SD. Participants without post-baseline tumor assessment were considered as failure in DCR. The 95% CI was estimated using the Clopper-Pearson method. Per mRECIST, CR was defined as the disappearance of any intratumoral arterial enhancement in all target lesions. PR: at least a 30% decrease in the sum of diameters of viable (contrast enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions. Stable disease (SD): any cases that do not qualify for either partial response or progressive disease.
Measured: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months
Disease Control Rate (DCR) As Assessed by The Investigator and Central Site Imaging Facility Based on iRECIST
DCR was defined as the percentage of participants with BOR of iCR, iPR or immune stable disease (iSD). Participants without post-baseline tumor assessment were considered a failure in DCR. The 95% CI was estimated using the Clopper-Pearson method. Per iRECIST, iCR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. iSD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. iRECIST is a modification to RECIST that considers unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression.
Measured: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months
Progression Free Survival (PFS) As Assessed by The Investigator Based on RECIST v1.1
PFS was defined as the time from the date of the first dose of study drug(s) to the date of the confirmed documentation of PD or death, whichever occurred first. PFS was estimated using the Kaplan-Meier method. Per RECIST v1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Measured: From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months)
Progression Free Survival (PFS) As Assessed by The Central Site Imaging Facility Based on RECIST v1.1
PFS was defined as the time from the date of the first dose of study drug(s) to the date of the confirmed documentation of PD or death, whichever occurred first. PFS was estimated using the Kaplan-Meier method. Per RECIST v1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Measured: From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months)
Progression Free Survival (PFS) As Assessed by The Investigator Based on mRECIST
PFS was defined as the time from the date of the first dose of study drug(s) to the date of the confirmed documentation of PD or death, whichever occurs first. PFS was estimated using the Kaplan-Meier method. Per mRECIST, PD was defined as an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since the treatment started.
Measured: From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months)
Progression Free Survival (PFS) As Assessed by The Central Site Imaging Facility Based on mRECIST
PFS was defined as the time from the date of the first dose of study drug(s) to the date of the confirmed documentation of PD or death, whichever occurs first. PFS was estimated using the Kaplan-Meier method. Per mRECIST, PD was defined as an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since the treatment started.
Measured: From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months)
Progression Free Survival (PFS) As Assessed by The Investigator Based on iRECIST
PFS was defined as the time from the date of the first dose of study drug(s) to the date of the confirmed documentation of progressive disease (iCPD) or death, whichever occurs first. PFS was estimated using the Kaplan-Meier method. Per iRECIST v1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. iRECIST is a modification to RECIST that considers unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression.
Measured: From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months)
Progression Free Survival (PFS) As Assessed by The Central Site Imaging Facility Based on iRECIST
PFS was defined as the time from the date of the first dose of study drug(s) to the date of the confirmed documentation of progressive disease (iCPD) or death, whichever occurs first. PFS was estimated using the Kaplan-Meier method. Per iRECIST v1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. iRECIST is a modification to RECIST that considers unique patterns of atypical response in immunotherapy and enables treatment beyond initial radiographic progression.
Measured: From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start4 Sep 2020
- Primary completion1 Dec 2022
- Study completion18 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401800
- Sponsor's protocol ID
- BGB-A317-211
- Other IDs
- CTR20200972
- Status last verified
- Feb 2025
- First submitted
- 21 May 2020
- Last updated
- 10 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Xu L, Chen J, Liu C, Song X, Zhang Y, Zhao H, Yan S, Jia W, Wu Z, Guo Y, Yang J, Gong W, Ma Y, Yang X, Gao Z, Zhang N, Zheng X, Li M, Su D, Chen M. Efficacy and safety of tislelizumab plus lenvatinib as first-line treatment in patients with unresectable hepatocellular carcinoma: a multicenter, single-arm, phase 2 trial. BMC Med. 2024 Apr 23;22(1):172. doi: 10.1186/s12916-024-03356-5.
PubMed 38650037
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Investigate the Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib in Patients With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04401800
- Acronym / sponsor ID
- BGB-A317-211
- Conditions
- Hepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma, Metastatic Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 18 Feb 2024 (actual)
- First posted
- 26 May 2020 (actual)
- Results
- Posted 10 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study was to assess the preliminary antitumor activity as indicated by overall response rate (ORR) of tislelizumab in combination with lenvatinib in participants with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC) by central site imaging facility per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenvatinib With Tislelizumab | Experimental | Drug: Lenvatinib, Drug: TislelizumabParticipants received lenvatinib based on baseline weight (12 milligrams [mg] or 8 mg once daily for participants with a baseline weight of >= 60 kilograms [kg] or < 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments
- Unresectable locally advanced or metastatic HCC, which must be confirmed by histologically or cytologically. Fibrolamellar, sarcomatoid, or mixed cholangiocarcinoma histology confirmed by histologically or cytologically is excluded.
- Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease that is not amenable to or has progressed after loco-regional therapy and is not amenable to a curative treatment approach
- Did not receive any systemic treatment before and is unwilling to accept standard of care treatment or not suitable for standard of care treatment as judged by investigators
- At least 1 measurable lesion as defined by RECIST v1.1
Key exclusion criteria (6 listed)
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Any active malignancy ≤ 2 years before the first dose of study drugs except for specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)
- Uncontrolled diabetes or > Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management, or ≥ Grade 3 hypoalbuminemia ≤ 14 days before the first dose of study drugs
- Any known brain or leptomeningeal metastases
- Concurrent participation in another therapeutic clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenvatinibCapsules administered orally once daily | Drug | Lenvatinib With Tislelizumab |
| Tislelizumab200 mg intravenous (IV) infusion administered on Day 1 of each cycle | Drug | Lenvatinib With Tislelizumab |
Primary outcome
Overall Response Rate (ORR) as Assessed by Central Imaging Facility Based on RECIST v1.1
Time frame: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months
ORR was defined as the percentage of participants achieving the best overall response (BOR) of complete response (CR) or partial response (PR). The 95% confidence interval (CI) was estimated using the Clopper-Pearson method. Per Response evaluation criteria in solid tumors (RECIST) version (v)1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
19 secondary outcomes
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Treatment Discontinuation and Modification
Time frame: From the date of the first dose of study drug up to 30 days after last dose of study drug (maximum time on treatment was 12 months)
Objective Response Rate (ORR) as Assessed by the Investigator Based on RECIST v1.1
Time frame: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; i.e., up to 27 months
Objective Response Rate (ORR) as Assessed by the Investigator and Central Site Imaging Facility Based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Time frame: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months
Objective Response Rate (ORR) as Assessed by the Investigator and Central Site Imaging Facility Based on Immune Related Response Evaluation Criteria in Solid Tumors (iRECIST)
Time frame: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months
Duration of Response (DOR) As Assessed by The Investigator Based on RECIST v1.1
Time frame: From the date of earliest response to the date of first documentation of disease progression or death, whichever occurred first (up to 35 months)
Duration of Response (DOR) As Assessed by The Central Site Imaging Facility Based on RECIST v1.1
Time frame: From the date of earliest response to the date of first documentation of disease progression or death, whichever occurred first (up to 35 months)
Duration of Response (DOR) As Assessed by The Investigator Based on mRECIST
Time frame: From the date of earliest response to the date of first documentation of disease progression or death, whichever occurred first (up to 35 months)
Duration of Response (DOR) As Assessed by the Central Site Imaging Facility Based on mRECIST
Time frame: From the date of earliest response to the date of first documentation of disease progression or death, whichever occurred first (up to 35 months)
Duration of Response (DOR) As Assessed by The Investigator Based on iRECIST
Time frame: From the date of earliest response to the date of first documentation of disease progression or death, whichever occurred first (up to 35 months)
Duration of Response (DOR) As Assessed by The Central Site Imaging Facility Based on iRECIST
Time frame: From the date of earliest response to the date of first documentation of disease progression or death, whichever occurs first (up to 35 months)
Disease Control Rate (DCR) As Assessed by The Investigator and Central Site Imaging Facility Based on RECIST v1.1
Time frame: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months
Disease Control Rate (DCR) As Assessed by The Investigator and Central Site Imaging Facility Based on mRECIST
Time frame: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months
Disease Control Rate (DCR) As Assessed by The Investigator and Central Site Imaging Facility Based on iRECIST
Time frame: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months
Progression Free Survival (PFS) As Assessed by The Investigator Based on RECIST v1.1
Time frame: From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months)
Progression Free Survival (PFS) As Assessed by The Central Site Imaging Facility Based on RECIST v1.1
Time frame: From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months)
Progression Free Survival (PFS) As Assessed by The Investigator Based on mRECIST
Time frame: From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months)
Progression Free Survival (PFS) As Assessed by The Central Site Imaging Facility Based on mRECIST
Time frame: From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months)
Progression Free Survival (PFS) As Assessed by The Investigator Based on iRECIST
Time frame: From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months)
Progression Free Survival (PFS) As Assessed by The Central Site Imaging Facility Based on iRECIST
Time frame: From date of first dose of study drug until the date of first documented progression or date of death from any cause, whichever came first (up to 35 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38650037Xu L, Chen J, Liu C, Song X, Zhang Y, Zhao H, Yan S, Jia W, Wu Z, Guo Y, Yang J, Gong W, Ma Y, Yang X, Gao Z, Zhang N, Zheng X, Li M, Su D, Chen M. Efficacy and safety of tislelizumab plus lenvatinib as first-line treatment in patients with unresectable hepatocellular carcinoma: a multicenter, single-arm, phase 2 trial. BMC Med. 2024 Apr 23;22(1):172. doi: 10.1186/s12916-024-03356-5.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
BeiGene
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenvatinib and Tislelizumab in people with Hepatocellular Carcinoma and Unresectable Hepatocellular Carcinoma, run by BeiGene at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) as Assessed by Central Imaging Facility Based on RECIST v1.1 (time frame: Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04401800, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.