Toripalimab or Placebo as Adjuvant Therapy in Hepatocellular Carcinoma After Radical Resection
NCT ID: NCT03859128
Last Updated: 2023-03-31
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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UNKNOWN
PHASE2/PHASE3
402 participants
INTERVENTIONAL
2019-03-05
2023-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group A
TORIPALIMAB 240mg ,Q3W, up to 16 cycles
TORIPALIMAB INJECTION(JS001 )
Arm A: Toripalimab 240mg IV(Injection of Vein) Q3W Arm B: Placebo 240mg IV(Injection of Vein) Q3W
Group B
Placebo 240mg Q3W, up to 16 cycles
TORIPALIMAB INJECTION(JS001 )
Arm A: Toripalimab 240mg IV(Injection of Vein) Q3W Arm B: Placebo 240mg IV(Injection of Vein) Q3W
Interventions
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TORIPALIMAB INJECTION(JS001 )
Arm A: Toripalimab 240mg IV(Injection of Vein) Q3W Arm B: Placebo 240mg IV(Injection of Vein) Q3W
Eligibility Criteria
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Inclusion Criteria
2. BICR confirmed no resdual tumor lesions are detected in liver;
3. Child-Puch score, Class A;
4. ECOG score is 0;
Exclusion Criteria
2. Portal vein tumor thrombi or liver metastases or recurrent liver cancer;
3. With symptoms of central nervous system metastasis;
4. With any history of active autoimmune disease or autoimmune disease;
5. Known liver diseases with clinical significance;
6. Patients infected by hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis D virus (HDV):
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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Zhongshan Hospital,Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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JS001-016-III-HCC
Identifier Type: -
Identifier Source: org_study_id
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