NCT07422753

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

A Prospective, Single-Center, Randomized, Double-Blind Clinical Study of TACE Combined With Sintilimab, Bevacizumab, and Ipilimumab N01 in the Treatment of Advanced Hepatocellular Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 safe and tolerable for patients with advanced HCC? Does this combination therapy show preliminary efficacy in treating advanced HCC? How do different sequencing schedules of ipilimumab N01 (given 3 weeks after sintilimab vs. concurrently with sintilimab) compare in terms of safety and efficacy? What potential biomarkers can predict treatment response? Researchers will compare three different treatment groups to assess the safety and efficacy of the combination and the role of ipilimumab N01 timing: Group A: Receives a single dose of ipilimumab N01 (3mg/kg IV) administered 3 weeks after the first dose of sintilimab, in combination with sintilimab (200mg IV, Q3W), bevacizumab (15mg/kg IV, Q3W), and TACE. Group B: Receives a single dose of ipilimumab N01 (3mg/kg IV) administered concurrently with the first dose of sintilimab, in combination with sintilimab (200mg IV, Q3W), bevacizumab (15mg/kg IV, Q3W), and TACE. Group C: Receives sintilimab (200mg IV, Q3W), bevacizumab (15mg/kg IV, Q3W), and TACE (without ipilimumab N01). Participants will: Be screened for eligibility. Eligible participants (36 adults with advanced, previously untreated, unresectable or metastatic HCC) will provide informed consent and be randomly assigned to one of the three treatment groups (A, B, or C) using a central randomization system. Receive the assigned study treatment according to their group's schedule. Undergo regular clinic visits for safety checkups, tumor imaging assessments (initially every 6 weeks, then every 12 weeks after 48 weeks), and response evaluation using RECIST v1.1 and RECICL criteria until disease progression, intolerable toxicity, or other study withdrawal criteria are met. Provide biological samples for exploratory biomarker analysis, including: Peripheral blood (10ml each time: 5ml in anticoagulant tube, 5ml in coagulant tube) 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 (±7 days) after the last study drug dose or before starting new anti-cancer therapy (whichever comes first). Subsequent survival follow-up contacts every 90 days (±7 days, which may be conducted via phone) to collect information on survival status and any subsequent anti-cancer treatments, until death, withdrawal of consent, or study closure.

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-03-01
• Completion: 2029-03-01
• First posted: 2026-02-20
• Last updated: 2026-02-20

Locations

1 site across 1 country: China