Trial intelligence / Profile preview

Lenvatinib plus Tislelizumab in Advanced HCC with HBV Infection

NCT05897138Phase 2

Key facts

Status: Not yet recruiting
Start: Aug 2023
Primary completion: Jun 2025
Sponsor: Fujian Medical University Cancer Hospital
Modality: Monoclonal Antibodies

Drugs: tislelizumab
Conditions: hepatocellular carcinoma (HCC)

Overview

Phase 2, open-label, single-arm trial of tislelizumab in hepatocellular carcinoma (HCC), sponsored by Fujian Medical University Cancer Hospital. Primary endpoint: Objective Response Rate at 12 months. Planned start Aug 2023; status: not yet recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Lenvatinib plus Tislelizumab
Lenvatinib 8mg or 12mg PO daily + Tislelizumab 200mg IV every 3 weeks.

Who it enrols

Adult patients aged 18-75 with locally advanced unresectable or metastatic HCC and HBV infection, Child-Pugh A or good B (<=7), ECOG 0-1, who have not received prior systemic therapy.

Endpoints

Primary

Objective Response Rate12 months

Secondary

Treatment-Emergent Adverse Eventsfrom first dose to within 30 days after the last dose
Duration of Response
Disease Control Rate12 months
Progression-Free Survivalup to 100 months
Overall Survivalup to 100 months

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