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Sintilimab + Bevacizumab Biosimilar as Neoadjuvant Therapy for Resectable HCC Beyond Milan Criteria

NCT07324824Phase 2

Key facts

Status: Recruiting
Start: Jan 2026
Primary completion: Jan 2029
Countries: 1
Sponsor: Sun Yat-sen University
Modality: Monoclonal Antibodies

Drugs: sintilimabbevacizumab
Conditions: hepatocellular carcinoma (HCC)

Overview

Phase 2, open-label, single-arm trial of sintilimab and bevacizumab in hepatocellular carcinoma (HCC), sponsored by Sun Yat-sen University. Primary endpoints: 1-year recurrence free survival rate and Adverse Events up to 2 years. Started Jan 2026; status: recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

sintilimab combined with bevacizumab biosimilar
Patients receive neoadjuvant sintilimab and bevacizumab biosimilar prior to surgical resection.

Who it enrols

Adults with resectable hepatocellular carcinoma beyond Milan criteria (CNLC Ib-IIa), Child-Pugh A, ECOG 0-1, no prior anti-HCC treatment. Excludes mixed/fibrolamellar HCC, severe portal hypertension/bleeding risk, recent thromboembolic events, active autoimmune disease, and active HBV/HCV above thresholds.

Endpoints

Primary

1-year recurrence free survival rate1 year
Adverse EventsUp to 2 years

Secondary

R0 resection rateUp to 2 years
pathological complete responseUp to 2 years
major pathological responseUp to 2 years
Overall survivalUp to 2 years
Recurrence free survivalUp to 2 years
Time to recurrenceUp to 2 years

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