NCT06090656

Bevacizumab in Combination With Sintilimab Versus Transcatheter Arterial Chemoembolization for the Treatment of Intermediate Stage Hepatocellular Carcinoma (Beyond Up-To-Seven Criteria)

Bevacizumab in Combination With Sintilimab Versus Transcatheter Arterial Chemoembolization for the Treatment of Intermediate Stage Hepatocellular Carcinoma (Beyond Up-To-Seven Criteria), A Prospective, Randomized, Controlled Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Transcatheter arterial chemoembolization (TACE) is recommended as the standard of care for patients with intermediate-stage hepatocellular carcinoma (HCC) (i.e., BCLC stage B). However, these patients is heterogeneous in terms of liver functional, tumor size and tumor number, and not all patients with mid-stage HCC will benefit from TACE. The ORIENT-32 trial confirmed the efficacy of sintilimab in combination with bevacizumab for unresectable hepatocellular carcinoma. No study has yet explored whether this regimen is appropriate for patients with BCLC stage B. The purpose of this study is to explore whether bevacizumab in combination with sintilimab is superior to conventional TACE therapy in patients with HCC with beyond-Up-to-seven criteria.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Bevacizumab combined with Sintilimab	Bevacizumab combined with sintilimab, sindilizumab 200 mg IV d1, Q3W, combined with bevacizumab 15 mg/kg IV d1, Q3W treatment, treatment continued until disease progression, development of intolerable toxic reactions
PROCEDURE	Transcatheter arterial chemoembolization	Transcatheter arterial chemoembolization, patients were treated with cTACE, and the efficacy was assessed by repeat CT/MRI 1 month after the initial treatment, and if the tumor still had arterial phase enhancement, TACE treatment could be supplemented until treatment failure and withdrawal of consent.

Timeline

• Start date: 2023-03-02
• Primary completion: 2025-07-25
• Completion: 2025-07-25
• First posted: 2023-10-19
• Last updated: 2024-07-03

Locations

1 site across 1 country: China