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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Biological: TORIPALIMAB INJECTION(JS001 )

• Study Type: Interventional
• Enrollment (Anticipated): 402
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital,Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; TORIPALIMAB 240mg ,Q3W, up to 16 cycles	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 16 cycles	Biological: TORIPALIMAB INJECTION(JS001 ); Arm A: Toripalimab 240mg IV(Injection of Vein) Q3W Arm B: Placebo 240mg IV(Injection of Vein) Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BICR-RFS	Defined as the time from randomization to the first documented disease recurrence or death.	Time frame is up to 31 months (for interim analysis, up to 44 months for Primary analysis)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 44 months
12-month recurrence-free survival rate (RFS12)	probability of patients without recurrence or death for any cause at Month 12	up to 44 months
24-month recurrence-free survival rate (RFS24)	probability of patients without recurrence or death for any cause at Month 24	up to 44 months
Time to recurrence (TTR)	the time from randomization to the first documented disease recurrence	up to 44 months
Time to local recurrence (TTLR)	the time from randomization to the first documented local disease recurrence	up to 44 months
Overall survival (OS)	the time from randomization to death for any cause	up to 44 months
12- and 24-month overall survival rate (OS12 and OS24)	probability of patients surviving at Month 12 and 24, respectively	up to 44 months
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	up to 44 months

Collaborators and Investigators

• Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2019
• Primary Completion (Anticipated): April 18, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: February 18, 2019
• First Submitted That Met QC Criteria: February 28, 2019
• First Posted (Actual): March 1, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: JS001-016-III-HCC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No