Hepatocellular CarcinomaPhase 2/3NCT05976568
A Study of QL1706 in Combination With Bevacizumab and/or Chemotherapy as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
A Phase 2/3 study testing QL1706, Bevacizumab and Oxaliplatin injection in people with Hepatocellular Carcinoma, run by Qilu Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of QL1706 in combination with bevacizumab and/or chemotherapy versus sintilimab in combination with bevacizumab as first-line treatment in patients with advanced hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- QL1706, Bevacizumab and Oxaliplatin injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 668 participants
- Where
- 2 sitesChina
- Study dates
- 1 Sep 2023to 1 Sep 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Subjects participate voluntarily and sign informed consent.
- Age ≥ 18 and ≤ 80 years old, male or female.
- Histological or cytological or clinical diagnosis of HCC
- Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgery and/or local treatment.
- No prior systemic therapy for HCC.
- Child-Pugh ≤7 , no history of hepatic encephalopathy.
Who cannot join
- Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc.
- History of malignancy other than HCC within 5 years prior to the start of study treatment.
- History of liver transplantation, or planned to receive liver transplantation.
- Moderate or severe ascites with clinical symptoms that require drainage, uncontrolled or moderate or severe pleural and pericardical effusion.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Involvement of both the main portal vein and the left and right branches by portal vein tumor thrombus, or of both the main trunk and the superior mesenteric vein concurrently, or of inferior vena cava.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Nanjing Tianyinshan Hospital
Nanjing, Jiangsu, 211199
Shukui Qin
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Jia Fan
About this study
Official title: A Phase II/III, Randomized, Open-label, Multi-center Study to Evaluate the Efficacy and Safety of QL1706 in Combination With Bevacizumab and/or Chemotherapy Versus Sintilimab in Combination With Bevacizumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
The purpose of this study is to assess the efficacy and safety of QL1706 in combination with bevacizumab and/or chemotherapy versus sintilimab in combination with bevacizumab as first-line treatment in patients with advanced hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- QL1706, Bevacizumab, Oxaliplatin injection, Capecitabine, Sintilimab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1706Drug
7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
BevacizumabDrug
15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
Oxaliplatin injectionDrug
85 mg/m2 administered as IV infusion on Day 1 of each 21-day cycle
CapecitabineDrug
1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle
SintilimabDrug
200 mg administered as IV infusion on Day 1 of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | QL1706 in combination with bevacizumab and chemotherapy Receives: Drug: QL1706; Drug: Bevacizumab; Drug: Oxaliplatin injection; Drug: Capecitabine |
| Arm 2 | Experimental | QL1706 in combination with bevacizumab Receives: Drug: QL1706; Drug: Bevacizumab |
| Arm 3 | Experimental | QL1706 in combination with chemotherapy Receives: Drug: QL1706; Drug: Oxaliplatin injection; Drug: Capecitabine |
| Arm 4 | Active comparator | Sintilimab in combination with bevacizumab Receives: Drug: Bevacizumab; Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) (Phase II)
ORR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Measured: Up to approximately 4 years
Incidence of Adverse Events (AEs) (Phase II)
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Measured: Up to approximately 4 years
Overall Survival (OS) (Phase III)
OS was defined as the time from randomization to death due to any cause.
Measured: Up to approximately 4 years
Secondary outcomes (10)
Objective Response Rate (ORR)
ORR was assessed by investigators per RECIST 1.1
Measured: Up to approximately 4 years
Disease Control Rate (DCR)
DCR was assessed by investigators per RECIST 1.1
Measured: Up to approximately 4 years
Duration of Response (DOR)
DOR was assessed by investigators per RECIST 1.1
Measured: Up to approximately 4 years
Progression-free Survival (PFS)
PFS was assessed by investigators per RECIST 1.1
Measured: Up to approximately 4 years
Time to progression (TTP)
TTP was assessed by investigators per RECIST 1.1
Measured: Up to approximately 4 years
Objective Response Rate (ORR)
ORR was assessed by investigators per mRECIST
Measured: Up to approximately 4 years
Disease Control Rate (DCR)
DCR was assessed by investigators per mRECIST
Measured: Up to approximately 4 years
Duration of Response (DOR)
DOR was assessed by investigators per mRECIST
Measured: Up to approximately 4 years
Progression-free Survival (PFS)
PFS was assessed by investigators per mRECIST
Measured: Up to approximately 4 years
Time to progression (TTP)
TTP was assessed by investigators per mRECIST
Measured: Up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 Qilu Pharmaceutical Co., Ltd.The 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 668 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jia Fan, Principal investigator, Fudan UniversityShukui Qin, Principal investigator, Nanjing Tianyinshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976568
- Sponsor's protocol ID
- QL1706-308
- Status last verified
- Jul 2023
- First submitted
- 28 Jul 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang F, Tao W, Zhong Z, Fan J, Yu H, Qin S. DUBHE-H-308 study protocol: rationale and adaptive design of a randomized, open-label, seamless phaseII/III trial of iparomlimab and tuvonralimab (QL1706)-based regimens versus sintilimab plus bevacizumab as first-line treatment for advanced hepatocellular carcinoma. Future Oncol. 2026 Oct 1:1-10. doi: 10.1080/14796694.2026.2739789. Online ahead of print.
PubMed 42820658
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III, Randomized, Open-label, Multi-center Study to Evaluate the Efficacy and Safety of QL1706 in Combination With Bevacizumab and/or Chemotherapy Versus Sintilimab in Combination With Bevacizumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05976568
- Acronym / sponsor ID
- QL1706-308
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 668 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 4 Aug 2023 (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.
The purpose of this study is to assess the efficacy and safety of QL1706 in combination with bevacizumab and/or chemotherapy versus sintilimab in combination with bevacizumab as first-line treatment in patients with advanced hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: QL1706, Drug: Bevacizumab, Drug: Oxaliplatin injection, Drug: CapecitabineQL1706 in combination with bevacizumab and chemotherapy |
| Arm 2 | Experimental | Drug: QL1706, Drug: BevacizumabQL1706 in combination with bevacizumab |
| Arm 3 | Experimental | Drug: QL1706, Drug: Oxaliplatin injection, Drug: CapecitabineQL1706 in combination with chemotherapy |
| Arm 4 | Active comparator | Drug: Bevacizumab, Drug: SintilimabSintilimab in combination with bevacizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects participate voluntarily and sign informed consent.
- Age ≥ 18 and ≤ 80 years old, male or female.
- Histological or cytological or clinical diagnosis of HCC
- Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgery and/or local treatment.
- No prior systemic therapy for HCC.
Key exclusion criteria (6 listed)
- Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc.
- History of malignancy other than HCC within 5 years prior to the start of study treatment.
- History of liver transplantation, or planned to receive liver transplantation.
- Moderate or severe ascites with clinical symptoms that require drainage, uncontrolled or moderate or severe pleural and pericardical effusion.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
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 |
|---|---|---|
| QL17067.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle | Drug | Arm 1, Arm 2, Arm 3 |
| Bevacizumab15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle | Drug | Arm 1, Arm 2, Arm 4 |
| Oxaliplatin injection85 mg/m2 administered as IV infusion on Day 1 of each 21-day cycle | Drug | Arm 1, Arm 3 |
| Capecitabine1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle | Drug | Arm 1, Arm 3 |
| Sintilimab200 mg administered as IV infusion on Day 1 of each 21-day cycle | Drug | Arm 4 |
Primary outcome
Objective Response Rate (ORR) (Phase II)
Time frame: Up to approximately 4 years
ORR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Incidence of Adverse Events (AEs) (Phase II)
Time frame: Up to approximately 4 years
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Overall Survival (OS) (Phase III)
Time frame: Up to approximately 4 years
OS was defined as the time from randomization to death due to any cause.
10 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to approximately 4 years
Disease Control Rate (DCR)
Time frame: Up to approximately 4 years
Duration of Response (DOR)
Time frame: Up to approximately 4 years
Progression-free Survival (PFS)
Time frame: Up to approximately 4 years
Time to progression (TTP)
Time frame: Up to approximately 4 years
Objective Response Rate (ORR)
Time frame: Up to approximately 4 years
Disease Control Rate (DCR)
Time frame: Up to approximately 4 years
Duration of Response (DOR)
Time frame: Up to approximately 4 years
Progression-free Survival (PFS)
Time frame: Up to approximately 4 years
Time to progression (TTP)
Time frame: Up to approximately 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Derived from this study: PubMed 42820658Yang F, Tao W, Zhong Z, Fan J, Yu H, Qin S. DUBHE-H-308 study protocol: rationale and adaptive design of a randomized, open-label, seamless phaseII/III trial of iparomlimab and tuvonralimab (QL1706)-based regimens versus sintilimab plus bevacizumab as first-line treatment for advanced hepatocellular carcinoma. Future Oncol. 2026 Oct 1:1-10. doi: 10.1080/14796694.2026.2739789. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Jia Fan principal investigator
Fudan University
Shukui Qin principal investigator
Nanjing Tianyinshan Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing QL1706, Bevacizumab and Oxaliplatin injection in people with Hepatocellular Carcinoma, run by Qilu Pharmaceutical Co., Ltd. at 2 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 6 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: opening soon, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Gao (+8613304321400, jian7.gao@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (Phase II) (time frame: Up to approximately 4 years). The study lists 3 primary outcomes in all. 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 NCT05976568, 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 4 Aug 2023.