Not yet recruiting NCT05976568
A Study of QL1706 in Combination With Bevacizumab and/or Chemotherapy as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QL1706, Bevacizumab, Oxaliplatin injection, Capecitabine.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug QL1706
7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle - Drug Bevacizumab
15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle - Drug Oxaliplatin injection
85 mg/m2 administered as IV infusion on Day 1 of each 21-day cycle - Drug Capecitabine
1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle - Drug Sintilimab
200 mg administered as IV infusion on Day 1 of each 21-day cycle
Primary outcome measures
- Objective Response Rate (ORR) (Phase II) [Time frame: Up to approximately 4 years]
- Incidence of Adverse Events (AEs) (Phase II) [Time frame: Up to approximately 4 years]
- Overall Survival (OS) (Phase III) [Time frame: Up to approximately 4 years]
Secondary outcome measures (10)
- 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]
Eligibility criteria
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 surgery and/or local treatment.
- No prior systemic therapy for HCC.
- Child-Pugh ≤7 , no history of hepatic encephalopathy.
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Nanjing Tianyinshan Hospital — Nanjing
- Zhongshan Hospital, Fudan University — Shanghai
Identifiers
NCT: NCT05976568 · QL1706-308