Postoperative recurrence remains a major limitation to long-term survival in hepatocellular carcinoma (HCC). In addition, a narrow surgical margin is widely regarded as a risk factor for recurrence. Neoadjuvant therapy may represent a strategy to reduce the risk of recurrence, thereby improving long-term outcomes. Tislelizumab plus lenvatinib has demonstrated promising efficacy with manageable safety in advanced HCC. Therefore, we will conduct a phase II study to compare neoadjuvant tislelizumab plus lenvatinib followed by surgery versus surgery alone in patients with stage IA HCC and an anticipated narrow surgical margin.
The patient voluntarily participates in this study and provides written informed consent.
Age ≥18 years at the time of consent; male or female.
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.
Child-Pugh class A hepatic function.
Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed-cell carcinoma, or fibrolamellar carcinoma; any other active malignancy concurrent with HCC or within the past 5 years, except for definitively treated localized tumors (e.g., basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, or breast carcinoma in situ).
Planned or prior solid-organ transplantation or allogeneic bone marrow transplantation (corneal transplantation is allowed).
Known hypersensitivity to macromolecular protein products, or known allergy to any excipients of tislelizumab.
Any active autoimmune disease or a history of autoimmune disease.