OncoMatch/Clinical Trials/NCT06498622
Adjuvant Treatment of Patients With High Risk of Recurrent Hepatocellular Carcinoma With Donafenib in Combination With Envafolimab
Is NCT06498622 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Donafenib + Envafolimab for hepatocellular carcinoma.
Treatment: Donafenib + Envafolimab — This is a multi-center, single arm study to evaluate the efficacy and safety of donafenib in combination with envafolimab treatment in patients with high risk of recurrent hepatocellular carcinoma after radical surgery.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: antitumour therapy
Exception: except antiviral therapy
Subjects with no previous antitumour therapy (except antiviral therapy). Previous antitumour therapy (except antiviral therapy) [excluded].
Lab requirements
Blood counts
ANC ≥ 1.5×10^9/L; HGB ≥ 90g/L; PLT ≥ 75×10^9/L
Kidney function
Serum creatinine ≤ 1.5×ULN
Liver function
Child-Pugh score ≤ 7; Serum albumin (ALB) ≥ 35g/L; Serum total bilirubin (TBIL) < 1.5×ULN; AST, ALT < 2.5×ULN
Cardiac function
NYHA grade III to IV cardiac insufficiency excluded; LVEF <50% excluded; acute cardiovascular disease within 1 month excluded; cardiovascular clinical symptoms or disease not well controlled excluded
No significant abnormality in routine laboratory tests (blood test, liver and kidney function, coagulation function, etc.): (1) Criteria for routine blood tests need to be met (no blood and blood products transfusion within 14 days): a. Absolute neutrophil value (ANC) ≥ 1.5*10^9/L; b. Haemoglobin (HGB) ≥ 90g/L; c. Platelet count (PLT) ≥ 75*10^9/L. (2) Biochemical tests need to meet the following criteria: a. Serum albumin (ALB) ≥ 35g/L; b. Serum total bilirubin (TBIL) < 1.5*Upper Limit of Normal (ULN); c. Serum glutamic transaminase (AST), alanine aminotransferase (ALT) < 2.5*ULN; d. Serum creatinine ≤ 1.5*ULN. Child-Pugh score ≤ 7. According to NYHA standard, grade III to IV cardiac insufficiency, or cardiac ultrasound examination suggests that the left ventricular ejection fraction (LVEF) <50% [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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