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A Prospective, Randomized Study of TACE Combined With Sintilimab, Bevacizumab, and Ipilimumab N01 Treating Advanced HCC

NCT07422753 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-04-24

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary efficacy of a combination therapy involving TACE, sintilimab, bevacizumab, and ipilimumab N01 for the treatment of advanced hepatocellular carcinoma (HCC). It also aims to explore the potential synergistic mechanisms of this combination. The main questions it aims to answer are:

Is the combination of TACE, sintilimab, bevacizumab, and ipilimumab N01 effective and safe for patients with advanced HCC? How do different sequencing schedules of ipilimumab N01 compare in terms of safety and efficacy? What potential biomarkers can predict treatment response?

Researchers will compare three different treatment groups:

Group A: Receives TACE and a single dose of ipilimumab N01 administered 3 weeks after the first dose of sintilimab and bevacizumab.

Group B: Receives TACE and a single dose of ipilimumab N01 administered concurrently with the first dose of sintilimab and bevacizumab.

Group C: Receives TACE, sintilimab and bevacizumab (without ipilimumab N01).

Participants will:

Be screened for eligibility and be randomly assigned to one of the three treatment groups.

Receive the assigned study treatment according to their group's schedule. Undergo regular clinic visits for safety checkups, tumor imaging assessments, and response evaluation using RECIST v1.1 and RECICL criteria.

Provide biological samples for exploratory biomarker analysis, including:

Peripheral blood at baseline and before each treatment cycle (every 3 weeks). Tumor biopsy specimens at baseline and 6 weeks after the first treatment. Surgical specimens if the patient undergoes conversion surgery.

Participate in follow-up visits:

A safety follow-up visit 30 days after the last study drug dose or before starting new anti-cancer therapy.

Subsequent survival follow-up contacts every 90 days to collect information on survival status and any subsequent anti-cancer treatments.

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

DRUG

placebo

The patient would receive placebo administered concurrently or 3 weeks after the first dose of sintilimab, in combination with sintilimab (200mg IV, Q3W), bevacizumab (15mg/kg IV, Q3W), and TACE.

DRUG

CTLA-4 Antibody(ipilimumab N01)

The patient would receive a single dose of ipilimumab N01 (3mg/kg IV) administered concurrently or 3 weeks after the first dose of sintilimab, in combination with sintilimab (200mg IV, Q3W), bevacizumab (15mg/kg IV, Q3W), and TACE.

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-25
Primary Completion
2027-03-31
Completion
2029-03-31

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT07422753 on ClinicalTrials.gov