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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT07422753
Phase
PHASE2
Status
Recruiting
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Conditions

  • Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • placebo — DRUG
    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.
  • CTLA-4 Antibody(ipilimumab N01) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 25, 2026
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2029

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: αCTLA-4 Combined with Delay
    Receives a single dose of ipilimumab N01 administered 3 weeks after the first dose of sintilimab and bevacizumab
  • Experimental: αCTLA-4 Combined Concurrently
    Receives a single dose of ipilimumab N01 administered concurrently with the first dose of sintilimab and bevacizumab
  • Placebo Comparator: No αCTLA-4 Combined
    Receives sintilimab and bevacizumab without ipilimumab N01

Primary Outcome Measure

ORR of Participants Assessed by RECIST1.1 [ Time Frame: Up to 6 months after randomization ]

Central Contacts

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