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OncoMatch/Clinical Trials/NCT07324824

Sintilimab Plus Bevacizumab Biosimilar as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma

Is NCT07324824 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies sintilimab combined with bevacizumab biosimilar for hepatocellular carcinoma.

Phase 2RecruitingSun Yat-sen UniversityNCT07324824Data as of May 2026

Treatment: sintilimab combined with bevacizumab biosimilarSurgical 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.

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Disease stage

Required: Stage IB, IIA

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: anti-angiogenic agent

Prior receipt of any anti-angiogenic agents

Cannot have received: anti-PD-1 therapy

Prior receipt of any ... anti-PD-1 antibodies

Cannot have received: anti-PD-L1 therapy

Prior receipt of any ... anti-PD-L1/L2 antibodies

Cannot have received: anti-PD-L2 therapy

Prior receipt of any ... anti-PD-L1/L2 antibodies

Cannot have received: anti-CTLA-4 therapy

Prior receipt of any ... anti-CTLA-4 antibodies

Cannot have received: immunotherapy

Prior receipt of any ... other immunotherapies

Lab requirements

Blood counts

sufficient organ and bone marrow function

Liver function

child-pugh class a

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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