NCT07309419

A Phase III Randomized Study of TACE Plus an Oral Triple-Agent Cocktail Versus TACE Plus First-Line Targeted Immunotherapy in Unresectable Hepatocellular Carcinoma

A Prospective, Randomized, Open-Label, Multicenter Phase III Trial Evaluating the Efficacy and Safety of Transarterial Chemoembolization Combined With an Oral Triple-Agent Cocktail Regimen Versus Transarterial Chemoembolization Combined With First-Line Targeted Therapy Plus Immunotherapy in Patients With Unresectable Hepatocellular Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 222 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, randomized, open-label phase 3 study evaluating the efficacy and safety of transarterial chemoembolization (TACE) combined with a triple oral cocktail regimen versus TACE combined with targeted therapy plus immunotherapy as first-line treatment for unresectable hepatocellular carcinoma (HCC).

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Apatinib	Apatinib: 250m, po, QD
DRUG	Camrelizumab	Camrelizumab: 200mg, iv, Q3W
DEVICE	TACE	TACE if necessary
DRUG	Thalidomide (drug)	Thalidomide：50-75mg, PO, qn;
DRUG	Capecitabine	Capecitabine: 500mg, PO, bid
DRUG	Compound cantharides capsule	Compound cantharides capsule: 750mg, PO, tid

Timeline

• Start date: 2025-12-22
• Primary completion: 2030-06-30
• Completion: 2030-06-30
• First posted: 2025-12-30
• Last updated: 2025-12-30