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

Primary Purpose

Hepatocellular Carcinoma

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TORIPALIMAB INJECTION(JS001 )
Sponsored by
Shanghai Junshi Bioscience Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhongshan Hospital,Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group A

Group B

Arm Description

TORIPALIMAB 240mg ,Q3W, up to 16 cycles

Placebo 240mg Q3W, up to 16 cycles

Outcomes

Primary Outcome Measures

BICR-RFS
Defined as the time from randomization to the first documented disease recurrence or death.

Secondary Outcome Measures

Investigator-RFS
the time from randomization to the date of the first documented progressive disease (tumor evlauation by BICR in accordance with RECIST 1.1), or to the date of death for any cause, whichever occurs first
12-month recurrence-free survival rate (RFS12)
probability of patients without recurrence or death for any cause at Month 12
24-month recurrence-free survival rate (RFS24)
probability of patients without recurrence or death for any cause at Month 24
Time to recurrence (TTR)
the time from randomization to the first documented disease recurrence
Time to local recurrence (TTLR)
the time from randomization to the first documented local disease recurrence
Overall survival (OS)
the time from randomization to death for any cause
12- and 24-month overall survival rate (OS12 and OS24)
probability of patients surviving at Month 12 and 24, respectively
Incidence of AEs
Incidence of AEs (including SAEs and AESIs) is evaluated by the investigator, and severity is determined in accordance with CTCAE v5.0

Full Information

First Posted
February 18, 2019
Last Updated
March 28, 2023
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03859128
Brief Title
Toripalimab or Placebo as Adjuvant Therapy in Hepatocellular Carcinoma After Radical Resection
Acronym
JUPITER 04
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) Versus Placebo as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence Following Radical Resection
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 5, 2019 (Actual)
Primary Completion Date
April 18, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Junshi Bioscience Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
402 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
TORIPALIMAB 240mg ,Q3W, up to 16 cycles
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
Placebo 240mg Q3W, up to 16 cycles
Intervention Type
Biological
Intervention Name(s)
TORIPALIMAB INJECTION(JS001 )
Intervention Description
Arm A: Toripalimab 240mg IV(Injection of Vein) Q3W Arm B: Placebo 240mg IV(Injection of Vein) Q3W
Primary Outcome Measure Information:
Title
BICR-RFS
Description
Defined as the time from randomization to the first documented disease recurrence or death.
Time Frame
Time frame is up to 31 months (for interim analysis, up to 44 months for Primary analysis)
Secondary Outcome Measure Information:
Title
Investigator-RFS
Description
the time from randomization to the date of the first documented progressive disease (tumor evlauation by BICR in accordance with RECIST 1.1), or to the date of death for any cause, whichever occurs first
Time Frame
up to 44 months
Title
12-month recurrence-free survival rate (RFS12)
Description
probability of patients without recurrence or death for any cause at Month 12
Time Frame
up to 44 months
Title
24-month recurrence-free survival rate (RFS24)
Description
probability of patients without recurrence or death for any cause at Month 24
Time Frame
up to 44 months
Title
Time to recurrence (TTR)
Description
the time from randomization to the first documented disease recurrence
Time Frame
up to 44 months
Title
Time to local recurrence (TTLR)
Description
the time from randomization to the first documented local disease recurrence
Time Frame
up to 44 months
Title
Overall survival (OS)
Description
the time from randomization to death for any cause
Time Frame
up to 44 months
Title
12- and 24-month overall survival rate (OS12 and OS24)
Description
probability of patients surviving at Month 12 and 24, respectively
Time Frame
up to 44 months
Title
Incidence of AEs
Description
Incidence of AEs (including SAEs and AESIs) is evaluated by the investigator, and severity is determined in accordance with CTCAE v5.0
Time Frame
up to 44 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HCC with at least one protocol defined risk factor, diagnosed confirmed by central pathological review and received R0 resection; BICR confirmed no resdual tumor lesions are detected in liver; Child-Puch score, Class A; ECOG score is 0; Exclusion Criteria: 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; Portal vein tumor thrombi or liver metastases or recurrent liver cancer; With symptoms of central nervous system metastasis; With any history of active autoimmune disease or autoimmune disease; Known liver diseases with clinical significance; Patients infected by hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis D virus (HDV): Other protocol defined inclusion/exclusion criteria could apply
Facility Information:
Facility Name
Zhongshan Hospital,Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

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Toripalimab or Placebo as Adjuvant Therapy in Hepatocellular Carcinoma After Radical Resection

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