Resectable Hepatocellular CarcinomaPhase 2NCT05519410
Sintilimab Combined With Lenvatinib Versus HAIC for Perioperative Treatment of Resectable Primary Hepatocellular Carcinoma
A Phase 2 study testing Sintilimab and Lenvatinib and HAIC-FOLFOX in people with Resectable Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a prospective, Two-arm, randomized，phase II clinical study of Sintilimab Combined With Lenvatinib Versus HAIC for perioperative treatment of resectable primary hepatocellular carcinoma with a high risk of recurrence. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Resectable Hepatocellular Carcinoma
- What is being tested?
- Sintilimab and Lenvatinib and HAIC-FOLFOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2022to 1 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients volunteered to participate in this study and signed informed consent;
- Age 18-75, male or female;
- ECOG PS score 0-1;
- Child-pugh liver function grading: Grade A
- The clinical diagnosis conforms to primary hepatocellular carcinoma (HCC) and the lesion conforms to the indications for resectable operation in the Guidelines for diagnosis and Treatment of HCC (2019) edition;
- According to the preoperative evaluation of the researcher, the patient had a high risk of recurrence and met at least one of the risk factors:
Show all 16Show fewer
- b: 2-3 tumors with the maximum diameter ≤3cm; IIa: tumor 2-3,biggest > 3 cm in diameter
- According to RECIST 1.1 standard, patients have at least one measurable lesion (CT/MRI scan long diameter ≥10mm or CT/MRI scan short diameter ≥15mm for lymph node lesions, and the lesion has not received radiotherapy, freezing or other local treatments);
- Expected survival ≥ 6 months;
- The function of vital organs meets the following requirements (excluding the use of any blood component and cell growth factor within 14 days) ;
- Blood routine:
- Neutrophils ≥1.5×109//L Platelet count ≥100×109/L Hemoglobin ≥90g/L;
- -Liver and kidney function: Serum creatinine (SCr) ≤ 1.5 times upper limit of normal value (ULN) or creatinine clearance ≥50 ml/min (Cockcroft-Gault formula); Total bilirubin (TBIL)≤ 1.5 times the upper limit of normal value (ULN); AST or ALT levels ≤ 2.5 times the upper limit of normal value (ULN); Urine protein <2+;If urinary protein ≥2+,24-hour quantitative urine protein must be ≤1g;
- Normal coagulation function, no active bleeding and thrombotic disease A. International standardized ratio INR≤1.5×ULN; B. Partial thromboplastin time APTT≤1.5×ULN; C. Prothrombin time PT≤1.5ULN;
- Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during and within six months of the end of medication; Patients with negative serum or urine pregnancy tests within 7 days prior to study inclusion and who must be non-lactating, and males should agree to use contraceptives during the study period and for 6 months after the end of the study period;
- Subjects have good compliance and cooperate with the follow-up.
Who cannot join
- Have received radiotherapy, chemotherapy, concurrent chemoradiotherapy or other targeted therapies before;
- Known hepatobiliary cell carcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma and fibre-lamellar cell carcinoma; Active malignancies other than HCC within 5 years or concurrently;
- Having hypertension that cannot be well controlled by antihypertensive drug therapy (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);Previous history of hypertension crisis or hypertensive encephalopathy;
- Subject has previous or concurrent malignancies (except cured basal cell carcinoma of skin and carcinoma in situ of the cervix);
- Previous treatment with Tislelizumab or other PD-1/PD-L1 treatment could not be enrolled; Subjects are known to have prior allergies to macromolecular protein reparations or to any Tislelizumab or Lenvatinib excipients;
- Subject has any active autoimmune disease or history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or childhood asthma have been completely relieved and may be included as adults without any intervention; Asthma requiring medical intervention with bronchodilators will not be included);
Show all 19Show fewer
- Subjects are receiving immunosuppressive, or systemic, or absorbable local hormone therapy for immunosuppression purposes (>10mg/ day prednisone or other therapeutic hormones) and continue to receive such therapy within 2 weeks prior to enrollment;
- Ascites or pleural effusion with clinical symptoms require therapeutic puncture or drainage;
- Clinical symptoms or diseases of the heart that are not well controlled, such as:
- NYHA2 or above heart failure Unstable angina pectoris Myocardial infarction occurred within 1 year
- Patients with clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention;
- The patient currently (within 3 months) has gastrointestinal diseases such as esophageal varices, active gastric and duodenal ulcers, ulcerative colitis, portal hypertension, or active bleeding in unresected tumors, or other conditions determined by the researchers that may cause gastrointestinal bleeding or perforation;
- Past or present severe bleeding (>30 ml bleeding within 3 months), hemoptysis (>5 ml fresh blood within 4 weeks) or thromboembolic events (including stroke events and/or tia) within 12 months;
- Subject has active infection or unexplained fever of >38.5 degrees during screening and before first administration (subject's fever due to tumor can be enrolled according to the investigator's judgment);
- Patients with past or present objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug related pneumonia, severe impairment of lung function, etc.;
- Subjects with congenital or acquired immune deficiency, such as HIV infection, or active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA≥1000/ml; Hepatitis C reference: HCV RNA≥103/ml);Chronic hepatitis B virus carriers, HBV DNA < 1000 IU/ml, must receive antiviral treatment at the same time during the test can be enrolled;
- Live vaccine is administered less than 4 weeks before or possibly during the study period;
- The subject has a known history of psychotropic substance abuse, alcohol abuse or drug abuse;
- The subject cannot or does not agree to bear the cost of the self-funded portion of the examination and treatment, except for the clinical study drug, combined chemotherapy and SAE related to the clinical study drug combined chemotherapy; Researchers think that should be left out in this study, the researchers determine, for example, the subjects have other factors that may result in this study were forced to midway termination, such as, other serious disease (including mental illness) need to merge treatment, there are serious abnormal laboratory examination, accompanied by factors such as family or society, will affect the safety of the subjects, or information and the collection of the sample.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060
Feng Fang, M.D., 022-23340123 ext. 3090, xyfangfeng@aliyun.com
About this study
Official title: A Prospective, Two-arm, Randomized，Phase II Clinical Study of Sintilimab Combined With Lenvatinib Versus Hepatic Artery Infusion Chemotherapy for Perioperative Treatment of Resectable Primary Hepatocellular Carcinoma With a High Risk of Recurrence.
This is a prospective, Two-arm, randomized，phase II clinical study of Sintilimab Combined With Lenvatinib Versus HAIC for perioperative treatment of resectable primary hepatocellular carcinoma with a high risk of recurrence.
- Conditions
- Resectable Hepatocellular Carcinoma
- Being tested
- Sintilimab and Lenvatinib, HAIC-FOLFOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab and LenvatinibDrug
Tislelizumab, 200mg, ivd,q3w; Lenvatinib,8mg/kg,po,qd.
HAIC-FOLFOXDrug
hepatic artery infusion Oxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 2400mg/m2 infusion 48h.
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab Combined With Lenvatinib | Experimental | Pre-operation: 2-3 cycles; Receives: Drug: Sintilimab and Lenvatinib |
| HAIC | Active comparator | Pre-operation: HAIC-FOLFOX 2-3 cycles; Receives: Drug: HAIC-FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year DFS%
1-year disease-free survival rate
Measured: 12month
Secondary outcomes (4)
ORR
objective response rate
Measured: 3 months
Percentage of MVI
Microvascular invasion
Measured: 4 months
Percentage of pCR
pathological complete response
Measured: 4 months
2-year DFS%
2-year disease-free survival rate
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start23 Aug 2022 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519410
- Sponsor's protocol ID
- Interventional
- Status last verified
- Aug 2022
- First submitted
- 23 Aug 2022
- Last updated
- 29 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Two-arm, Randomized，Phase II Clinical Study of Sintilimab Combined With Lenvatinib Versus Hepatic Artery Infusion Chemotherapy for Perioperative Treatment of Resectable Primary Hepatocellular Carcinoma With a High Risk of Recurrence.
- ClinicalTrials.gov ID
- NCT05519410
- Acronym / sponsor ID
- Interventional
- Conditions
- Resectable Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 23 Aug 2022 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, Two-arm, randomized，phase II clinical study of Sintilimab Combined With Lenvatinib Versus HAIC for perioperative treatment of resectable primary hepatocellular carcinoma with a high risk of recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sintilimab Combined With Lenvatinib | Experimental | Drug: Sintilimab and LenvatinibPre-operation: 2-3 cycles; |
| HAIC | Active comparator | Drug: HAIC-FOLFOXPre-operation: HAIC-FOLFOX 2-3 cycles; |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients volunteered to participate in this study and signed informed consent;
- Age 18-75, male or female;
- ECOG PS score 0-1;
- Child-pugh liver function grading: Grade A
- The clinical diagnosis conforms to primary hepatocellular carcinoma (HCC) and the lesion conforms to the indications for resectable operation in the Guidelines for diagnosis and Treatment of HCC (2019) edition;
Key exclusion criteria (19 listed)
- Have received radiotherapy, chemotherapy, concurrent chemoradiotherapy or other targeted therapies before;
- Known hepatobiliary cell carcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma and fibre-lamellar cell carcinoma; Active malignancies other than HCC within 5 years or concurrently;
- Having hypertension that cannot be well controlled by antihypertensive drug therapy (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);Previous history of hypertension crisis or hypertensive encephalopathy;
- Subject has previous or concurrent malignancies (except cured basal cell carcinoma of skin and carcinoma in situ of the cervix);
- Previous treatment with Tislelizumab or other PD-1/PD-L1 treatment could not be enrolled; Subjects are known to have prior allergies to macromolecular protein reparations or to any Tislelizumab or Lenvatinib excipients;
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 |
|---|---|---|
| Sintilimab and LenvatinibTislelizumab, 200mg, ivd,q3w; Lenvatinib,8mg/kg,po,qd. | Drug | Sintilimab Combined With Lenvatinib |
| HAIC-FOLFOXhepatic artery infusion Oxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 2400mg/m2 infusion 48h. | Drug | HAIC |
Primary outcome
1-year DFS%
Time frame: 12month
1-year disease-free survival rate
4 secondary outcomes
ORR
Time frame: 3 months
Percentage of MVI
Time frame: 4 months
Percentage of pCR
Time frame: 4 months
2-year DFS%
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
Related trials for Resectable Hepatocellular Carcinoma
Not yet recruitingPhase 2
NIVO+IPI Neoadjuvant Therapy for Recurrent Resectable HCC
Hepatocellular Carcinoma (HCC), Recurrent Hepatocellular Cancer
Not yet recruitingObservational study
Integration of Imaging, Molecular, Pathological, and Clinical Outcome Data in Hepatocellular Carcinoma.
Resectable Hepatocellular Carcinoma (HCC)
Not yet recruitingObservational study
Immune-Related Adverse Events and Clinical Outcomes of First-Line Immunotherapy in Egyptian Patients With Unresectable Hepatocellular Carcinoma
Hepatocellular Carcinoma, Hepatocellular Carcinoma (HCC)
Active, not recruiting
BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma Non-resectable
Active, not recruitingPhase 1
Nivolumab With or Without Relatlimab for Patients With Potentially Resectable Hepatocellular Carcinoma
Hepatocellular Carcinoma
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.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sintilimab and Lenvatinib and HAIC-FOLFOX in people with Resectable Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site 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 16 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year DFS% (time frame: 12month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2022.