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NCT Number: NCT03859128

Toripalimab or Placebo as Adjuvant Therapy in Hepatocellular Carcinoma After 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Zhongshan Hospital,Fudan University

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TORIPALIMAB INJECTION(JS001 )

Biological

Arm A: Toripalimab 240mg IV(Injection of Vein) Q3W Arm B: Placebo 240mg IV(Injection of Vein) Q3W

Primary outcomes

  1. BICR-RFS

    Time frame: Time frame is up to 100 months (for interim analysis, up to 92 months for Primary analysis)

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

Secondary outcomes

  1. Investigator-RFS

    Time frame: up to 100 months

    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

  2. 12-month recurrence-free survival rate (RFS12)

    Time frame: up to 100 months

    probability of patients without recurrence or death for any cause at Month 12

  3. 24-month recurrence-free survival rate (RFS24)

    Time frame: up to 100 months

    probability of patients without recurrence or death for any cause at Month 24

  4. Time to recurrence (TTR)

    Time frame: up to 44 months

    the time from randomization to the first documented disease recurrence

  5. Time to local recurrence (TTLR)

    Time frame: up to 44 months

    the time from randomization to the first documented local disease recurrence

  6. Overall survival (OS)

    Time frame: up to 44 months

    the time from randomization to death for any cause

  7. 12- and 24-month overall survival rate (OS12 and OS24)

    Time frame: up to 44 months

    probability of patients surviving at Month 12 and 24, respectively

  8. Incidence of AEs

    Time frame: up to 44 months

    Incidence of AEs (including SAEs and AESIs) is evaluated by the investigator, and severity is determined in accordance with CTCAE v5.0

Sponsors and collaborators

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd.

Other

Registry information

Official study 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

Acronym: JUPITER 04

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Mar 1, 2019
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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