NCT05883176

TACE Combined With Bevacizumab in HCC (BCLC-B) Beyond Up-To-Seven Criteria

TACE Combined With Bevacizumab in Patients With BCLC-B Stage Hepatocellular Carcinoma Beyond Up-To-Seven Criteria: a Prospective Single-arm Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with anti-VEGF (Bevacizumab Biosimilar) in patients with BCLC-B stage hepatocellular carcinoma beyond up-to-seven criteria.

Detailed description

This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of TACE combined with anti-VEGF (Bevacizumab Biosimilar) in patients with BCLC-B stage hepatocellular carcinoma beyond up-to-seven criteria. Subjects who meet the admission criteria will be treated with Bevacizumab Biosimilar after TACE until disease progression, intolerable toxicity, death, patient withdrawal or the investigators determine that the drug must be discontinued. The primary outcome is the objective response rate (ORR). The secondary outcomes include the duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival rate (OSR) in 6- and 12-months, the median progression-free survival time (mPFS) and median overall survival time (mOS). This study also aims to assess the safety and adverse events of TACE combined with anti-VEGF (Bevacizumab Biosimilar) for HCC (BCLC-B stage) beyond up-to-seven criteria.

Conditions

• Hepatocellular Carcinoma by BCLC Stage

Interventions

Type	Name	Description
DRUG	Bevacizumab Biosimilar QL 1101	TACE + Bevacizumab (15mg/kg, intra-arterial infusion, Q3W) for 4 cycles, followed by maintenance therapy with Bevacizumab (15mg/kg, intravenously, Q3W) to a maximum total cycle of 18 unless any evidence of disease progression or unacceptable side effects.

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-05-31
• Completion: 2025-07-01
• First posted: 2023-05-31
• Last updated: 2023-05-31

Locations

1 site across 1 country: China