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Toripalimab or Placebo as Adjuvant Therapy in Hepatocellular Carcinoma After Curative Hepatic Resection (JUPITER 04)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859128
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai Junshi Bioscience Co., Ltd.

Study Description
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Brief Summary:
This study will investigate if Toripalimab (A PD-1 Inhibitor) will improve recurrence-free survival (RFS) compared to placebo in participants with HCC and are at high risk of recurrence after complete resection with no residual of tumour.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Biological: TORIPALIMAB INJECTION(JS001 ) Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Toripalimab (Recombinant Humanized Anti-PD-1 Monoclonal Antibody, JS001) / Placebo as Adjuvant Therapy in Patients With Local Advanced Hepatocellular Carcinoma After Curative Hepatic Resection
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : October 24, 2022
Estimated Study Completion Date : April 12, 2024
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group A
TORIPALIMAB 240mg ,Q3W, up to 48 Weeks
 Biological: TORIPALIMAB INJECTION(JS001 )
Arm A: Toripalimab 240mg IV(Injection of Vein) Q3W Arm B: Placebo 240mg IV(Injection of Vein) Q3W
Placebo Comparator: Group B
Placebo 240mg Q3W, up to 48 Weeks
 Biological: TORIPALIMAB INJECTION(JS001 )
Arm A: Toripalimab 240mg IV(Injection of Vein) Q3W Arm B: Placebo 240mg IV(Injection of Vein) Q3W


Outcome Measures
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Primary Outcome Measures :
  1. RFS(Recurrence free survival) [ Time Frame: up to 44 months ]
    Defined as the time from randomization to the first documented disease recourrence or death.


Secondary Outcome Measures :
  1. TTR(Time to recurrence) [ Time Frame: up to 44 months ]
    Define as the time from randomization to the first documented disease recourrence or death.

  2. TTLR(Time to local recurrence) [ Time Frame: up to 44 months ]
    Define as the time from randomization to the first documented local disease recourrence or death.

  3. OS(Overall survival) [ Time Frame: up to 60 months ]
    Defined as time from randomization and the date of death.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HCC with at least one protocol defined risk factor, diagnosed confirmed by central pathological review and received R0 resection;
  2. BICR confirmed no resdual tumor lesions are detected in liver;
  3. Child-Puch score, Class A;
  4. ECOG score is 0;

Exclusion Criteria:

  1. Patients previously received PD-1 antibody, PD-L1 antibody, PD-L2 antibody or CTLA-4 antibodies, including those who have participated in the JS001 clinical study;
  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):

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859128


Contacts
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Contact: Jia Fan, Prof +86 13601669720 fan.jia@zs-hospital.sh.cn

Locations
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China, Shanghai
Zhongshan Hospital,Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Shanghai Junshi Bioscience Co., Ltd.
More Information
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Responsible Party: Shanghai Junshi Bioscience Co., Ltd.
ClinicalTrials.gov Identifier: NCT03859128    
Other Study ID Numbers: JS001-016-III-HCC
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases