Actively Recruiting
Ipilimumab N01 Combined With Sintilimab, Bevacizumab Biosimilar, and Hepatic Arterial Infusion Chemotherapy as Conversion Therapy for Unresectable Intermediate-Advanced Hepatocellular Carcinoma
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2026-05-01
43
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Ipilimumab N01 Combined With Sintilimab, Bevacizumab Biosimilar, and Hepatic Arterial Infusion Chemotherapy as Conversion Therapy for Unresectable Intermediate-Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before starting any study procedures
- Age 18 to 75 years, any gender
- Clinically or pathologically confirmed hepatocellular carcinoma (HCC) per 2024 guidelines
- No prior anti-tumor therapy for HCC
- Unresectable locally advanced or advanced HCC (CNLC Stage IIa-IIIb)
- Expected survival longer than 6 months
- ECOG performance status of 0 or 1
- Child-Pugh liver function class A or B
- Adequate organ function with specific blood count, liver, kidney, coagulation, and thyroid function levels
- Negative pregnancy test for females of childbearing potential within 3 days before first treatment
- Agreement to use effective contraception during and after treatment as specified
You will not qualify if you...
- Fibrolamellar HCC, sarcomatoid HCC, or combined hepatocellular-cholangiocarcinoma
- Recurrent HCC
- Hepatic encephalopathy diagnosed within past 6 months
- Autoimmune hepatitis confirmed by liver biopsy
- History of organ transplantation or hepatic encephalopathy
- Diffuse hepatocellular carcinoma
- Symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage
- History of renal disease or nephrotic syndrome
- Recent variceal bleeding or severe varices with high bleeding risk
- Arterial or venous thromboembolic events within past 6 months (excluding stable catheter-related thrombosis)
- Severe bleeding disorders or ongoing thrombolytic therapy
- Long-term use of anti-platelet agents
- Uncontrolled hypertension or history of hypertensive crises
- Symptomatic congestive heart failure or serious arrhythmias
- Recent gastrointestinal perforation, fistula, bowel obstruction, extensive bowel surgery, or inflammatory bowel disease
- Major surgery within 4 weeks before first dose or non-healing wounds
- History of pulmonary fibrosis or severe lung diseases
- Active hepatitis B or C infections exceeding viral load thresholds
- Active tuberculosis or recent anti-TB treatment
- HIV infection or active syphilis
- Severe infections requiring hospitalization within 4 weeks
- Active autoimmune disease requiring systemic therapy within 2 years
- Recent systemic immunosuppressive drugs use excluding certain corticosteroids
- Recent live attenuated vaccine use
- Recent use of Chinese herbal or immunomodulatory anti-tumor agents
- Uncontrolled metabolic or systemic diseases that increase risk
- Diagnosis of another malignancy within 5 years except certain skin cancers
- Prior treatment with immune checkpoint inhibitors
- Known hypersensitivity to study drugs
- Participation in another interventional trial within 4 weeks
- Pregnancy or breastfeeding
- Any other condition increasing risk or interfering with study participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
H
Huikai Li, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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