Sintilimab Combined With Bevacizumab as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma Beyond the Milan Criteria: A Single-Arm, Prospective Phase II Study
Surgical resection is the preferred therapeutic modality for patients with resectable hepatocellular carcinoma (HCC). However, the recurrence rate of HCC remains up to 70%. Neoadjuvant therapy for HCC could potentially reduce the risk of postoperative recurrence and prolong overall survival. Nevertheless, there is no standard neoadjuvant treatment regimen for HCC to date. In recent years, targeted therapy and immunotherapy are proved to improve the prognosis of advanced HCC patients. Previous study (ORIENT-32) has confirmed that, compared with sorafenib, sintilimab combined with bevacizumab biosimilar can delay tumor progression, reduce the risk of death, and exhibit a favorable safety profile in patients with advanced HCC. Therefore, we conducted a prospective, single-arm phase II study to investigate the efficacy of sintilimab combined with a bevacizumab biosimilar as neoadjuvant therapy in patients with resectable HCC beyond the Milan criteria.
• Able to provide informed consent and willing to sign an approved consent form;
• Aged ≥ 18 years;
• Clinically diagnosed or pathologically confirmed resectable hepatocellular carcinoma beyond the Milan criteria (CNLC Ib-IIa);
• No prior anti-HCC treatment;
• Child-Pugh class A.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Expected survival time of \> 6 months.
• Sufficient organ and bone marrow function.