Last updated: July 28, 2023
Sponsor: Qilu Pharmaceutical Co., Ltd.
Overall Status: Active - Not Recruiting
Phase
2/3
Condition
Carcinoma
Liver Disease
Abdominal Cancer
Treatment
Bevacizumab
Sintilimab
QL1706
Clinical Study ID
NCT05976568
QL1706-308
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 surgeryand/or local treatment.
- No prior systemic therapy for HCC.
- Child-Pugh ≤7 , no history of hepatic encephalopathy.
Exclusion
Exclusion Criteria:
- 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 studytreatment.
- History of liver transplantation, or planned to receive liver transplantation.
- Moderate or severe ascites with clinical symptoms that require drainage, uncontrolledor moderate or severe pleural and pericardical effusion.
- Has known active central nervous system (CNS) metastases and/or carcinomatousmeningitis.
- Involvement of both the main portal vein and the left and right branches by portalvein tumor thrombus, or of both the main trunk and the superior mesenteric veinconcurrently, or of inferior vena cava.
Study Design
Total Participants: 668
Treatment Group(s): 5
Primary Treatment: Bevacizumab
Phase: 2/3
Study Start date:
September 01, 2023
Estimated Completion Date:
September 01, 2027
Connect with a study center
Nanjing Tianyinshan Hospital
Nanjing, Jiangsu 211199
ChinaSite Not Available
Zhongshan Hospital, Fudan University
Shanghai, Shanghai 200032
ChinaSite Not Available

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