Ipilimumab N01 Combined With Sintilimab, Bevacizumab Biosimilar, and Hepatic Arterial Infusion Ch… (NCT07560488) | Clinical Trial Compass
RecruitingPhase 2
Ipilimumab N01 Combined With Sintilimab, Bevacizumab Biosimilar, and Hepatic Arterial Infusion Chemotherapy as Conversion Therapy for Unresectable Intermediate-Advanced Hepatocellular Carcinoma
China43 participantsStarted 2026-03-30
Plain-language summary
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
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L without granulocyte colony-stimulating factor support within 14 days;
✓. Platelet count ≥ 80×10⁹/L without transfusion within 14 days;
✓. Hemoglobin \> 9 g/dL without transfusion or erythropoietin within 14 days;
✓. Total bilirubin ≤ 1.5×upper limit of normal (ULN); or total bilirubin \> ULN with direct bilirubin ≤ ULN;
✓. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3×ULN;
✓. Serum creatinine ≤ 1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥ 60 mL/min;
✓. Adequate coagulation function defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5×ULN;
✓. Normal thyroid function defined as thyroid-stimulating hormone (TSH) within normal limits. Subjects with abnormal baseline TSH but normal total T3 (or FT3) and FT4 are also eligible;
Exclusion criteria
What they're measuring
1
Conversion resection rate
Timeframe: up to 1 year
Trial details
NCT IDNCT07560488
SponsorTianjin Medical University Cancer Institute and Hospital