This study will evaluate the efficacy and safety of therapy perioperative treatment with HAIC combined with donafenib and sintilimab (group A)/ donafenib combined with sintilimab (group B) compared with direct surgery (group C) in resectable HCC patients who are at high risk for disease recurrence.
Voluntary enrollment with written informed consent obtained
Age 18 to 75 years (inclusive), regardless of gender
Histologically or pathologically confirmed previously untreated hepatocellular carcinoma (HCC) or clinically diagnosed previously untreated HCC according to the AASLD guidelines.
Initial resectable status as assessed by the investigator (expected to achieve R0 resection, sufficient liver remnant volume, and Child-Pugh class A, as per the "Chinese Expert Consensus on Neoadjuvant Therapy for Liver Cancer (2023 Edition)").
Patients with distant metastasis.
Patients with portal vein tumor thrombosis (Vp3-Vp4).
History of any other malignant tumor within the past 5 years, unless the patient has received potentially curative treatment and there is no evidence of recurrence in the past 5 years. This 5-year time requirement does not apply to patients who have successfully undergone resection for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, or other carcinoma in situ.
History or current presence of congenital or acquired immunodeficiency diseases.
Parallel
HAIC combined with sintilimab and donafenib
DrugHAIC: Two cycles, Q3W. The chemotherapy regimen consists of oxaliplatin 85 mg/m² over 2 hours and raltitrexed 2 mg/m² over 1 hour. Donafenib: Treatment should begin the day after the completion of the first HAIC, with an initial dose of 0.1g bid p.o.. The investigator may increase the dose to 0.2g bid depending on the patient's condition. Sintilimab: Administration may begin after the first HAIC, 200 mg iv Q3W. After surgery, continued sintilimab and donafenib for 6 cycles.
Sintilimab and Donafenib
DrugDonafenib: an initial dose of 0.1g bid p.o. The investigator may increase the dose to 0.2g bid depending on the patient's condition. Sintilimab: 200 mg iv Q3W. After surgery, continued sintilimab and donafenib for 6 cycles.
Surgery
Procedure/SurgeryAfter surgery, received sintilimab and donafenib for 6 cycles.
1-yr RFS rate
the proportion of patients who have not experienced recurrence or death from any cause at 12 months after hepatectomy.
MPR rate
The percentage of patients with 70%-99% tumor necrosis found during surgery after neoadjuvant therapy
pCR rate
the percentage of participants having a pathCR
ORR
The percentage of subjects in the overall population who achieved CR or PR according to the mRECIST criteria
RFS
RFS is defined as the time from liver resection to the first documented occurrence of intrahepatic or extrahepatic HCC, or death from any cause (whichever occurs first).
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