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NOT YET RECRUITING
NCT07392866
PHASE2/PHASE3

A Clinical Study of SH006 Injection in Combination Therapy Versus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma

Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

SH006

15 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

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