Actively Recruiting
Perioperative Sintilimab Plus Bevacizumab Biosimilar and TACE-HAIC for HCC Patients With PVTT: A Phase-2 Clinical Trial
Led by Sun Yat-sen University · Updated on 2025-07-23
43
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Although resection provided survival benefit for selected HCC patients with PVTT, the recurrence rate is still high for those patients. It is still unknown whether perioperative Sintilimab, a PD-1antibody, plus bevacizumab biosimilar and TACE-HAIC will improve the survival for those patients. We initialed this phase 2 clinical trial to prove the perioperative therapy.
CONDITIONS
Official Title
Perioperative Sintilimab Plus Bevacizumab Biosimilar and TACE-HAIC for HCC Patients With PVTT: A Phase-2 Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically diagnosed or pathologically confirmed resectable advanced hepatocellular carcinoma with at least one measurable untreated lesion
- Child-Pugh liver function score of 6 points or less (Child-Pugh A)
- BCLC stage C disease with PVTT classified as VP1-2, and a single liver lesion or multiple lesions with a total diameter of 10 cm or less
- Newly diagnosed patients without prior targeted therapy or immunotherapy
- ECOG performance status of 0 to 1
- Expected survival of at least 12 weeks
- Adequate vital organ function without recent corrective treatment drugs within 14 days before first treatment
You will not qualify if you...
- Active or history of autoimmune disease
- Previous systemic or local therapy for hepatocellular carcinoma before enrollment
- Severe allergic reactions to other monoclonal antibodies
- Known central nervous system metastasis or hepatic encephalopathy
- Liver tumor burden greater than 50% of total liver volume or past liver transplantation
- Symptomatic ascites requiring drainage or recent ascites drainage within 3 months
- Poorly controlled high blood pressure (systolic 6140 mmHg or diastolic 690 mmHg)
- Uncontrolled cardiac symptoms or diseases including heart failure, unstable angina, recent myocardial infarction, or significant arrhythmias
- Abnormal coagulation with bleeding risk or ongoing anticoagulation therapy (except preventive low-dose aspirin or heparin)
- Recent significant bleeding episodes within 3 months or severe esophageal/gastric varices
- Recent arterial or venous thrombosis events within 6 months
- Known bleeding or clotting disorders
- Urine protein exceeding defined limits
- Other malignant tumors within past 3 years (except cured skin or cervical carcinoma in situ)
- Recent palliative radiotherapy for bone metastases affecting >5% bone marrow
- Prior anti-PD-1/PD-L1 therapy or targeted therapy
- Live vaccine administered less than 4 weeks before or during study
- Other serious diseases or conditions that could affect study participation or outcomes
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
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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