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A Study of QL1706 in Combination With Bevacizumab and/or Chemotherapy as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Sponsor: Qilu Pharmaceutical Co., Ltd.
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.
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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
668
Start Date
2023-09-01
Completion Date
2027-09-01
Last Updated
2023-08-04
Healthy Volunteers
No
Conditions
Interventions
QL1706
7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
Bevacizumab
15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
Oxaliplatin injection
85 mg/m2 administered as IV infusion on Day 1 of each 21-day cycle
Capecitabine
1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle
Sintilimab
200 mg administered as IV infusion on Day 1 of each 21-day cycle
Locations (2)
Nanjing Tianyinshan Hospital
Nanjing, Jiangsu, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China