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 (Jun 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
Treatments studied
Other
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT06498622 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages