Status:
TERMINATED
Toripalimab in Combination With Lenvatinib as Neoadjuvant Therapy in Resectable Hepatocellular Carcinoma
Lead Sponsor:
Shanghai Junshi Bioscience Co., Ltd.
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will evaluate efficacy and safety of Toripalimab Injection (JS001) with or without Lenvatinib as a Neoadjuvant Therapy in patients with Resectable Hepatocellular Carcinoma (HCC)
Eligibility Criteria
Inclusion
- Confirmed by histopathological or cytological examination; The criteria for resectability is met; Has at least one evaluable lesion according to the RECIST 1.1 standard and has not received local treatment;
- Exclusion Criteria:
- Patients who previously received anti-programmed death receptor-1 (PD-1) antibody, anti-programmed death ligand-1 (PD-L1) antibody, anti-programmed death ligand-2 (PD-L2) antibody or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibodies, including those who have participated in a JS001 clinical study;
- Patients with a history of gastroesophageal varices or active cardia ulcers associated with a high risk of bleeding; Patients who have upper gastrointestinal hemorrhage within 1 year; Patients known to have fibrous layer HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC; Other protocol defined inclusion/exclusion criteria could apply
Exclusion
Key Trial Info
Start Date :
April 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03867370
Start Date
April 26 2019
End Date
August 8 2023
Last Update
November 29 2023
Active Locations (1)
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1
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032