NCT07392866

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of the combination therapy of SH006 injection in the treatment of advanced hepatocellular carcinoma

Detailed description

This is an open, randomized, multicenter study aimed at evaluating the safety and efficacy of SH006 injection (15 mg/kg) in combination with bevacizumab and/or oxaliplatin/capecitabine versus regorafenib in the treatment of patients with advanced hepatocellular carcinoma

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-03-01
• Primary completion: 2030-03-01
• Completion: 2030-03-01
• First posted: 2026-02-06
• Last updated: 2026-02-09

Locations

2 sites across 1 country: China