NCT07324824

Sintilimab Plus Bevacizumab Biosimilar as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma

Sintilimab Combined With Bevacizumab as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma Beyond the Milan Criteria: A Single-Arm, Prospective Phase II Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hepatocellular Carcinoma
• Neoadjuvant Therapy
• Sintilimab
• Bevacizimab

Interventions

Type	Name	Description
DRUG	sintilimab combined with bevacizumab biosimilar	Drug: Sintilimab: 200mg IV Q3W D1 (3 cycles) Drug: Bevacizumab Biosimilar: 15mg/kg, IV, Q3W, D1 (2 cycles)

Timeline

• Start date: 2026-01-14
• Primary completion: 2029-01-01
• Completion: 2030-01-01
• First posted: 2026-01-08
• Last updated: 2026-01-16

Locations

1 site across 1 country: China