Adjuvant Treatment of Patients With High Risk of Recurrent Hepatocellular Carcinoma After Radical Surgery With Donafenib in Combination With Envafolimab: a Prospective, Multicentre, Single-arm Phase II Clinical Study
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.
• 18-80 years old, male and female.
• Subjects voluntarily enrolled in this study and signed the informed consent, good compliance and co-operated with the follow-up.
• Primary hepatocellular carcinoma with postoperative histopathological diagnosis of HCC and negative margins.
• Presence of any of the following high-risk factors for recurrence: ① tumor size ≥5.0cm combined with microvascular invasion; ② number of tumors ≥3; ③ presence of portal vein cancer thrombus (vp1 or vp2 type).
• No recurrence of metastasis confirmed by imaging examination 3-7 weeks after surgery.
• ECOG score of 0-1.
• Expected survival ≥ 3 months.
• Child-Pugh score ≤ 7.
• Subjects with no previous antitumour therapy (except antiviral therapy)
• No extra-hepatic metastases or lymph node metastases.
• 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.