Toripalimab in Combination With Lenvatinib as Neoadjuvant Therapy in Resectable Hepatocellular Carcinoma
NCT ID: NCT03867370
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2019-04-26
2023-08-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Group A
During the neoadjuvant period, the patients will receive a single dose JS001 intravenous infusion of 480 mg. After the operation, the patients will receive JS001 240 mg Q3W for up to 48 weeks.
Toripalimab (JS001 )
Given IV
Group B (Toripalimab, Lenvatinib)
During the neoadjuvant period, the patients will receive a single dose JS001 intravenous infusion of 480 mg in combination with oral lenvatinib at a starting dose of 8 or 12 mg once a day. After the operation, the patients will receive JS001 240 mg Q3W and lenvatinib for up to 48 weeks.
Toripalimab (JS001 ) Lenvatinib
Given IV 4 mg capsules
Group C (Toripalimab, Lenvatinib)
During the neoadjuvant period, the patients will receive a single dose JS001 intravenous infusion of 480 mg in combination with oral lenvatinib at a starting dose of 8 or 12 mg once a day. After the operation, the patients will receive JS001 240 mg Q3W for up to 48 weeks.
Toripalimab (JS001 ) Lenvatinib
Given IV 4 mg capsules
Interventions
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Toripalimab (JS001 )
Given IV
Toripalimab (JS001 ) Lenvatinib
Given IV 4 mg capsules
Toripalimab (JS001 ) Lenvatinib
Given IV 4 mg capsules
Eligibility Criteria
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Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Junshi Bioscience Co., Ltd.
OTHER
Responsible Party
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Locations
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Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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Fang Y, Liu W, Tang Z, Ji X, Zhou Y, Song S, Tian M, Tao C, Huang R, Zhu G, Jiang X, Gao J, Qu W, Wang H, Zhou P, Wu X, Jin L, Sun H, Ding Z, Peng Y, Zhao S, Zhou J, Fan J, Xu W, Shi Y. Monocarboxylate transporter 4 inhibition potentiates hepatocellular carcinoma immunotherapy through enhancing T cell infiltration and immune attack. Hepatology. 2023 Jan 1;77(1):109-123. doi: 10.1002/hep.32348. Epub 2022 Feb 7.
Other Identifiers
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JS001-020-Ib-HCC
Identifier Type: -
Identifier Source: org_study_id