TACE Combined with Sintilimab Plus Bevacizumab Biosimilar in Patients with Advanced Hepatocellular Carcinoma (TASK-02)

NCT04954794 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2024-10-31

No results posted yet for this study

Summary

The objective of this study is to evaluate the efficacy and safety of TACE combined with Sintilimab plus bevacizumab biosimilar in patients with advanced hepatocellular carcinoma as first-line therapy.

Conditions

Interventions

DRUG

Sintilimab

Sintilimab will be administered at 200 mg i.v. every 3 weeks plus a bevacizumab biosimilar at 15 mg/kg i.v. every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

COMBINATION_PRODUCT

TACE

TACE is performed by using drug-eluting beads or using microspheres combined with Lipiodol-pirarubicin emulsion per Investigator's decision. TACE treatment starts at day 0. Sintilimab plus a bevacizumab biosimilar will be initiated on day 14 after TACE.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Peng Wang, MD · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-14
Primary Completion
2024-04-29
Completion
2024-04-29

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04954794 on ClinicalTrials.gov