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

Sponsor
Sun Yat-sen University
Study ID
NCT05883176
Phase
PHASE2
Status
Unknown

Conditions

  • Hepatocellular Carcinoma by BCLC Stage

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab Biosimilar QL 1101 — DRUG
    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.

Study Details

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.

Key Dates

First listed
May 31, 2023
Start date
Jun 1, 2023
Status verified
May 2023
Primary completion
May 31, 2025
Completion
Jul 1, 2025

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: B-TACE
    TACE Combined With Bevacizumab Biosimilar

Primary Outcome Measure

Objective response rate (ORR) by RECIST 1.1 and mRECIST [ Time Frame: From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to 2 years) ]

Central Contacts