HAIC Combined with Donafenib and Sintilimab As Perioperative Treatment for Resectable Hepatocellular Carcinoma Patients At High Risk of Recurrence: a Prospective, Multicenter, Randomized Phase II Study
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)).
• At least one measurable lesion according to mRECIST criteria.
• Tumor burden meets one of the following conditions:
‣ A single tumor with a diameter \> 5 cm;
⁃ Multiple tumors with the largest tumor diameter \> 3 cm, with \< 5 tumors in total;
⁃ Presence of portal vein tumor thrombus (Vp1-Vp2).
• Liver function: Child-Pugh score of 5-6.
• ECOG 0-1
• Life expectancy of at least 3 months.
• Women of childbearing potential (defined as not postmenopausal or surgically sterilized) must have a negative serum pregnancy test within 7 days prior to the study drug administration.
• Both women and men of childbearing potential must use reliable contraception during the study and for 60 days following the last dose of the study drug.
• For HBV-infected patients: If HBV-DNA is ≥ 10⁴ copies/ml within 14 days prior to enrollment, antiviral therapy (preferably entecavir) must be initiated to reduce HBV-DNA to \< 10⁴ copies/ml before entering the study. Antiviral therapy should continue, with regular monitoring of liver function and HBV-DNA levels.
• Adequate organ function.