A Clinical Study of SH006 Injection in Combination Therapy Versus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma
NCT07392866 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-02-09
Summary
To evaluate the efficacy and safety of the combination therapy of SH006 injection in the treatment of advanced hepatocellular carcinoma
Conditions
- Hepatocellular Carcinoma (HCC)
Interventions
- DRUG
-
SH006
15 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
-
160 mg orally once daily for 21 days continuous dosing followed by a 7-day break of each 28-day cycle
Sponsors & Collaborators
-
Nanjing Sanhome Pharmaceutical, Co., Ltd.
lead INDUSTRY
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
- 2026-03-01
- Primary Completion
- 2030-03-01
- Completion
- 2030-03-01
Countries
- China
Study Locations
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