Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07594340
PHASE3

HAIC vs. TACE Combined With Sintilimab and Bevacizumab for Intermediate HCC (Beyond Up-To-Seven)

Sponsor: Binkui Li

View on ClinicalTrials.gov

Summary

The purpose of this prospective, randomized, multicenter, controlled clinical study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) compared to transarterial chemoembolization (TACE) when both are combined with sintilimab and bevacizumab for patients with intermediate-stage hepatocellular carcinoma (HCC). Specifically, the trial focuses on patients with a high tumor burden that exceeds the Up-To-Seven criteria.While TACE is the standard treatment for BCLC stage B HCC, its effectiveness is often limited in patients with extensive intrahepatic tumor loads. This study investigates whether the combination of FOLFOX-HAIC and systemic therapy (sintilimab plus bevacizumab) provides better local control and survival outcomes than the combination of TACE and the same systemic therapy. Experimental Group: Patients receive FOLFOX-HAIC (up to 4 cycles in the first 16 weeks) combined with sintilimab and bevacizumab. Control Group: Patients receive on-demand TACE (up to 4 cycles in the first 16 weeks) combined with sintilimab and bevacizumab. Primary Objective: To compare Progression-Free Survival (PFS) between the two arms as evaluated by mRECIST. Enrollment: A total of 300 patients will be randomized at a 1:1 ratio to the treatment groups. The study aims to provide high-level clinical evidence for optimizing treatment strategies for this specific subgroup of HCC patients.

Official title: Hepatic Arterial Infusion Chemotherapy Plus Sintilimab and Bevacizumab Versus Transarterial Chemoembolization Plus Sintilimab and Bevacizumab for Intermediate-Stage Hepatocellular Carcinoma Beyond the Up-To-Seven Criteria:A Prospective, Randomized, Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-05-15

Completion Date

2030-05-30

Last Updated

2026-05-22

Healthy Volunteers

No

Interventions

PROCEDURE

Procedure (FOLFOX-HAIC): Max 4 cycles within first 16 weeks.

Drug (Sintilimab): 200mg IV Q3W (Up to 12 months). Drug (Bevacizumab): 15mg/kg IV Q3W (Up to 12 months). Procedure (FOLFOX-HAIC): Max 4 cycles within first 16 weeks. Oxaliplatin: 130mg/m² infusion (2h). Leucovorin: 400mg/m² infusion (2h). 5-FU: 400mg/m² bolus (10min) + 1200mg/m² infusion (23h).

PROCEDURE

TACE (transarterial chemoembolization) combined with targeted/immunotherapy

Drug (Sintilimab): 200mg IV Q3W (Up to 12 months). Drug (Bevacizumab): 15mg/kg IV Q3W (Up to 12 months). Procedure (TACE): On-demand (max 4 cycles within 16 weeks). Epirubicin (30mg/m²) + Lobaplatin (30-50mg) + Lipiodol (5-20ml).

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China