Ipilimumab N01 Combined With Sintilimab, Bevacizumab Biosimilar, and Hepatic Arterial Infusion Chemotherapy as Conversion Therapy for Unresectable Intermediate-Advanced Hepatocellular Carcinoma

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT07560488
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Conversion Therapy
  • HCC - Hepatocellular Carcinoma

Eligibility Criteria

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

Interventions

  • Bevacizumab Biosimilar IBI305 — DRUG
    7.5 mg/kg, iv, q3w, 3 cycles (discontinue 1 week before surgery)
  • ipilimumab N01 — DRUG
    3mg/kg, iv, q6w, 2 cycles
  • Sintilimab — DRUG
    200mg, iv, q3w, 4 cycles
  • HAIC — DRUG
    FOLFOX-HAIC, q3w, 4 cycles

Study Details

Conversion therapy for unresectable intermediate-advanced hepatocellular carcinoma (uHCC) has evolved from systemic therapy to combined local-systemic approaches, but current regimens still have limited surgical conversion rates. This prospective, single-arm phase II study evaluates a combination regimen of PD-1 inhibitor (sintilimab) plus CTLA-4 inhibitor (ipilimumab N01), bevacizumab biosimilar, and HAIC for patients with initially unresectable intermediate-advanced HCC. The primary goal is to achieve a higher surgical conversion rate with manageable safety

Key Dates

Start date
Mar 30, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
43 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ipilimumab N01+Sintimab+Bevacizumab+HAIC

Primary Outcome Measure

Conversion resection rate [ Time Frame: up to 1 year ]

Central Contacts

Related Studies