Sintilimab Plus Bevacizumab Biosimilar as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma

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.

NCT Number	NCT07324824
Lead Sponsor	Sun Yat-sen University
Conditions	Hepatocellular Carcinoma, Neoadjuvant Therapy, Sintilimab, Bevacizimab
Enrollment	37 participants
Start Date	2026-01-14
Primary Completion	2029-01 (estimated)
Study Completion	2030-01 (estimated)
Updated on ClinicalTrials.gov	2026-01-16