A Study of QL1706 in Combination With Bevacizumab and/or Chemotherapy as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
NCT05976568 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 668
Last updated 2023-08-04
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.
Conditions
Interventions
- DRUG
-
QL1706
7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
- DRUG
-
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
-
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
Sponsors & Collaborators
-
Qilu Pharmaceutical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jia Fan · Fudan University
-
Shukui Qin · Nanjing Tianyinshan Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-01
- Primary Completion
- 2027-09-01
- Completion
- 2027-09-01
Countries
- China
Study Locations
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