TACE Combined With Sintilimab and Bevacizumab for Unresectable HCC

Sponsor
Second Affiliated Hospital of Guangzhou Medical University
Study ID
NCT04592029
Phase
PHASE1
Status
Completed

Conditions

  • Hepatocellular Carcinoma Non-resectable

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TACE combined with sintilimab and bevacizumab — DRUG
    Sintilimab and bevacizumab are administered at 3-7 days after the first TACE. The study includes dose escalation and dose expansion stage. 6-9 subjects will be enrolled in dose escalation stage for the safety and efficacy evaluation. Then, Sintilimab 200mg IV. q3w+ select specific dose of bevacizumab (7.5mg/kg or 15 mg/kg IV. q3w), expand to 36-39 patients for the further safety and efficacy study. The study treatment of sintilimab and bevacizumab lasts up to 24 months. TACE can be repeated when indicated clinically.

Study Details

This study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization (TACE) combined with sintilimab and bevacizumab in patients with unresectable intermediate or advanced hepatocellular carcinoma (HCC).

Key Dates

First listed
Oct 19, 2020
Start date
Oct 21, 2020
Status verified
Aug 2026
Primary completion
Feb 7, 2023
Completion
Mar 17, 2024

Study Design

Enrollment
36 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TACE-Sin-Bev
    TACE combined with sintilimab and bevacizumab.

Primary Outcome Measure

Adverse Events (AEs) [ Time Frame: 24 months ]

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