TACE Combined With Sintilimab Plus Bevacizumab Biosimilar in Hepatocellular Carcinoma (BCLC-C Stage ): a Prospective Single-arm Phase II Clinical Study

Sponsor
Sun Yat-sen University
Study ID
NCT04796025
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • Sintilimab; Bevacizumab Biosimilar — DRUG
    1-4 cycles, intra-arterial infusion: sindilimab 200mg + bevacizumab 7.5mg/kg, q3w; 5-18 cycles: Sintilimab (200mg ivdrip D1 Q3W)+Bevacizumab Biosimilar (15mg/kg ivdrip D1 Q3W）

Study Details

The purpose of this study is to evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with pd-1 antibody immunotherapy (Sintilimab) and anti-VEGF (Bevacizumab Biosimilar) in patients with advanced hepatocellular carcinoma (BCLC-C Stage).

Key Dates

First listed
Mar 12, 2021
Start date
Sep 23, 2021
Status verified
Sep 2021
Primary completion
Aug 31, 2023
Completion
Aug 31, 2024

Study Design

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

Arms

  • Experimental: T-Double
    TACE Combined With Sintilimab Plus 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

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