NCT05976568Not yet recruitingPhase 2/3
A Study of QL1706 in Combination With Bevacizumab and/or Chemotherapy as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
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
Source: ClinicalTrials.gov · Last updated 4 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 668 (estimated)
- First submitted
- 28 Jul 2023
- Start date
- 1 Sept 2023
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05976568
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 668
- From 1 Sept 2023 to the primary completion date, 1 Sept 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanjing Tianyinshan Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
Related publications
- 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 · PMID 42820658
This page is information, not medical advice. Discuss any trial with your doctor.