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Toripalimab + Sorafenib in Advanced Hepatocellular Carcinoma
NCT04926532Phase 2
Key facts
- Status
- Unknown
- Start
- Aug 2019
- Primary completion
- Oct 2021
- Countries
- 1
- Sponsor
- Zhongshan Hospital, Fudan University
- Modality
- Immune Checkpoint Inhibitors, Recombinant Proteins and Enzymes
- Drugs
- toripalimab
- Conditions
- hepatocellular carcinoma (HCC)
01
Overview
Phase 2, open-label, single-arm trial of toripalimab in hepatocellular carcinoma (HCC), sponsored by Zhongshan Hospital, Fudan University. Primary endpoint: Objective Response Rate at 1 year. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Toripalimab + Sorafenib
Toripalimab 240 mg IV every 3 weeks + Sorafenib orally twice daily.
03
Who it enrols
Patients with advanced hepatocellular carcinoma (Stage IIb or III) who are ineligible for surgery or TACE, have Child-Pugh A or B liver function, and have not received prior systemic therapy.
04
Endpoints
Primary
Objective Response Rate
Secondary
Progression Free Survival
Disease Control Rate
Duration of Relief
Overall Survival
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