TACE Combined With Sintilimab and Bevacizumab for Unresectable HCC

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

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/kg 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
Sep 27, 2020
Status verified
Sep 2021
Primary completion
Jun 30, 2022
Completion
Dec 31, 2022

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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