Status:
NOT_YET_RECRUITING
A Study of QL1706 in Combination With Bevacizumab and/or Chemotherapy as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief 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 i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
668 Patients enrolled
Trial Details
Trial ID
NCT05976568
Start Date
September 1 2023
End Date
September 1 2027
Last Update
August 4 2023
Active Locations (2)
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1
Nanjing Tianyinshan Hospital
Nanjing, Jiangsu, China, 211199
2
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032