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A Clinical Study of SH006 Injection in Combination Therapy Versus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma
Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd.
Summary
To evaluate the efficacy and safety of the combination therapy of SH006 injection in the treatment of advanced hepatocellular carcinoma
Official title: A Prospective, Randomized, Active-Controlled, Open-Label, National Multicenter Phase II/III Registration Study of SH006 Injection Combination Therapy Versus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-03-01
Completion Date
2030-03-01
Last Updated
2026-02-09
Healthy Volunteers
No
Conditions
Interventions
SH006
15 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
Regorafenib
160 mg orally once daily for 21 days continuous dosing followed by a 7-day break of each 28-day cycle
Locations (2)
Nanjing Tianyinshan Hospital
Nanjing, Jiangsu, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China