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OncoMatch/Clinical Trials/NCT07186621

Adjuvant Radiotherapy of Sintilimab Versus TACE for HCC

Is NCT07186621 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Sintilimab for hepatocellular carcinoma (hcc).

Phase 3RecruitingCancer Institute and Hospital, Chinese Academy of Medical SciencesNCT07186621Data as of May 2026

Treatment: Sintilimab — This study is an open-label, randomized controlled, multicenter, phase III clinical trial

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: targeted therapy (tyrosine kinase inhibitors)

Previous anti-HCC therapies, including but not limited to: targeted therapy (e.g., tyrosine kinase inhibitors)

Cannot have received: immune checkpoint inhibitor (PD-1/PD-L1 inhibitors)

Previous anti-HCC therapies, including but not limited to: immune checkpoint inhibitors (e.g., PD-1/PD-L1 inhibitors)

Cannot have received: systemic chemotherapy

Previous anti-HCC therapies, including but not limited to: systemic chemotherapy

Cannot have received: radiotherapy

Previous radiotherapy involving the abdomen

Lab requirements

Blood counts

Hb≥80g/L，ANC≥1.0×10^9 /L，PLT≥40×10^9 /L

Kidney function

Serum creatinine (CRE) and BUN ≤2.5× ULN

Liver function

Child-Pugh Class: A5, A6, or B7; ALT ≤2.5× ULN (if HBV/HCV positive, ALT ≤1.5× ULN). If ALT ≤1.5× ULN, AST ≤6× ULN (excluding AST elevation due to myocardial infarction). If ALT 1.5-2.5× ULN, AST ≤2.5× ULN.

Cardiac function

No significant ECG abnormalities and no severe cardiac dysfunction

Child-Pugh Class: A5, A6, or B7. ALT ≤2.5× ULN (if HBV/HCV positive, ALT ≤1.5× ULN). If ALT ≤1.5× ULN, AST ≤6× ULN (excluding AST elevation due to myocardial infarction). If ALT 1.5-2.5× ULN, AST ≤2.5× ULN. Serum creatinine (CRE) and BUN ≤2.5× ULN. Hb≥80g/L，ANC≥1.0×10^9 /L，PLT≥40×10^9 /L. No significant ECG abnormalities and no severe cardiac dysfunction.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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