NCT07560488
Recruiting
Phase 2
Conversion Therapy With Ipilimumab N01 Combined With Sintilimab, Bevacizumab Biosimilar, and Hepatic Arterial Infusion Chemotherapy for Unresectable Intermediate-Advanced Hepatocellular Carcinoma: A Prospective, Single-Arm Phase II Study
Tianjin Medical University Cancer Institute and Hospital1 site in 1 country43 target enrollmentStarted: March 30, 2026Last updated:
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Conversion resection rate
Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Written informed consent must be signed prior to initiation of any study-related procedures;
- •Age ≥ 18 years, and ≤75 years, regardless of gender;
- •Clinically diagnosed or histologically/cytologically confirmed hepatocellular carcinoma (HCC) according to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition);
- •No prior anti-tumor therapy for HCC before study treatment
- •Unresectable locally advanced or advanced HCC (CNLC Stage IIa-IIIb).
- •Expected overall survival \> 6 months.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
- •Child-Pugh score class A or B
- •Adequate organ function defined by the following laboratory parameters:
- •Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L without granulocyte colony-stimulating factor support within 14 days;
Exclusion Criteria
- •Target disease exceptions:
- •Fibrolamellar HCC, sarcomatoid HCC, or combined hepatocellular-cholangiocarcinoma.
- •Recurrent HCC.
- •Clinically diagnosed hepatic encephalopathy within the most recent 6 months.
- •Autoimmune hepatitis (requiring liver biopsy confirmation);
- •History of organ transplantation or history of hepatic encephalopathy;
- •Diffuse hepatocellular carcinoma;
- •Symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage;
- •History of any renal disease or nephrotic syndrome.
- •Variceal bleeding (esophageal or gastric varices) due to portal hypertension within the past 6 months;severe (Grade 3) varices on endoscopy within 3 months before first dose;evidence of portal hypertension (e.g., splenomegaly \>10 cm in longest diameter with platelets \<100×10⁹/L on imaging) with high bleeding risk as assessed by the investigator;
Arms & Interventions
Ipilimumab N01+Sintimab+Bevacizumab+HAIC
Experimental
Intervention: Bevacizumab Biosimilar IBI305 (Drug)
Ipilimumab N01+Sintimab+Bevacizumab+HAIC
Experimental
Intervention: ipilimumab N01 (Drug)
Ipilimumab N01+Sintimab+Bevacizumab+HAIC
Experimental
Intervention: Sintilimab (Drug)
Ipilimumab N01+Sintimab+Bevacizumab+HAIC
Experimental
Intervention: HAIC (Drug)
Outcomes
Primary Outcomes
Conversion resection rate
Time Frame: up to 1 year
The percentage of initially unresectable patients who underwent curative resection after protocol-specified conversion therapy.
Secondary Outcomes
- Objective response rate(up to 1 year)
- R0 Resection Rate(up to 1 year)
- Pathological Complete Response(up to 1 year)
- Overall survival(up to 3 years)
- Treatment-Related Adverse Events (TRAE)(up to 3 years)
Investigators
Study Sites (1)
Loading locations...
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