OncoMatch/Clinical Trials/NCT06664996
Sintilimab Combined SBRT As Neoadjuvant Therapy for Resectable HCC with PVTT
Is NCT06664996 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Sintilimab (approved) for hepatocellular carcinoma (hcc).
Treatment: Sintilimab (approved) — The goal of this single-arm, prospective clinical trial is to evaluate the safety and efficacy of neoadjuvant therapy combining sintilimab with stereotactic body radiation therapy (SBRT) in patients with resectable hepatocellular carcinoma (HCC) with branch portal vein tumor thrombus. The main questions it aims to answer are: 1. Is the combination of sintilimab and SBRT safe as neoadjuvant therapy? 2. How effective is this combination in treating resectable HCC with branch PVTT? Participants will be given a combination treatment of sintilimab and SBRT. Researchers will monitor their health conditions to assess the safety and effectiveness of this treatment protocol.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: targeted therapy
No prior treatments including targeted therapy, systemic chemotherapy, interventional treatments, surgical interventions, or radiotherapy before enrollment.
Cannot have received: systemic chemotherapy
No prior treatments including targeted therapy, systemic chemotherapy, interventional treatments, surgical interventions, or radiotherapy before enrollment.
Cannot have received: interventional treatment
No prior treatments including targeted therapy, systemic chemotherapy, interventional treatments, surgical interventions, or radiotherapy before enrollment.
Cannot have received: surgical intervention
No prior treatments including targeted therapy, systemic chemotherapy, interventional treatments, surgical interventions, or radiotherapy before enrollment.
Cannot have received: radiotherapy
No prior treatments including targeted therapy, systemic chemotherapy, interventional treatments, surgical interventions, or radiotherapy before enrollment.
Cannot have received: immunotherapy
Previous treatments including interventional, immunotherapy, chemotherapy, or targeted therapy.
Lab requirements
Blood counts
platelet count ≥70×10^9/L, white blood cells count ≥3000/mm^3, and absolute neutrophil count ≥1500/mm^3 without transfusion to meet entry criteria
Kidney function
serum creatinine ≤1.5 times the upper limit of normal, estimated glomerular filtration rate ≥50 mL/min/1.73m^2
Liver function
total bilirubin ≤2 times the upper limit of normal; AST and ALT ≤2.5 times the upper limit of normal; AST/ALT ratio ≤3 times the upper limit of normal; Child-Pugh A (score ≤6)
Cardiac function
No significant cardiac arrhythmias, myocardial ischemia, severe atrioventricular block, heart failure, or severe valvular heart disease.
Adequate organ and bone marrow function indicated by: serum creatinine ≤1.5 times the upper limit of normal, estimated glomerular filtration rate ≥50 mL/min/1.73m^2; total bilirubin ≤2 times the upper limit of normal; AST and ALT ≤2.5 times the upper limit of normal; AST/ALT ratio ≤3 times the upper limit of normal; platelet count ≥70×10^9/L, white blood cells count ≥3000/mm^3, and absolute neutrophil count ≥1500/mm^3 without transfusion to meet entry criteria. Liver function classified as Child-Pugh A (score ≤6). Significant cardiac arrhythmias, myocardial ischemia, severe atrioventricular block, heart failure, or severe valvular heart disease [excluded]. Severe bone marrow failure [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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