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Trial intelligence / Profile preview
Sintilimab plus Lenvatinib and TACE in advanced HCC
NCT05608200Phase 3
Key facts
- Status
- Recruiting
- Start
- Nov 2022
- Primary completion
- Oct 2026
- Countries
- 1
- Sponsor
- Second Affiliated Hospital of Guangzhou Medical University
- Modality
- Monoclonal Antibodies
- Drugs
- sintilimab
- Conditions
- hepatocellular carcinoma (HCC)
01
Overview
Phase 3, randomised, open-label trial of sintilimab in hepatocellular carcinoma (HCC) (2 arms), sponsored by Second Affiliated Hospital of Guangzhou Medical University. Primary endpoint: Overall Survival at 4 years. Started Nov 2022; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Len-Sin-TACE
Lenvatinib + Sintilimab + TACE
Len-TACE
Lenvatinib + TACE
03
Who it enrols
Patients with advanced HCC (BCLC stage C or CNLC IIIa-IIIb), Child-Pugh A/B, and no prior systemic or locoregional therapy for HCC.
04
Endpoints
Primary
Overall Survival
Secondary
Progression-Free Survival
Time to Progression
Objective Response Rate
Disease Control Rate
Adverse Events
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