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NCT03859128: JUPITER 04

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

Status unknown Phase 2, PHASE3 Last updated 31 March 2023
What this trial tests

Phase 2, PHASE3 trial testing TORIPALIMAB INJECTION(JS001 ) in Hepatocellular Carcinoma in 402 participants. Status unknown.

Timeline
5 March 2019
Primary endpoint
18 April 2023
1 August 2023

Quick facts

Lead sponsorShanghai Junshi Bioscience Co., Ltd.
PhasePhase 2, PHASE3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment402
Start date5 March 2019
Primary completion18 April 2023
Estimated completion1 August 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Shanghai Junshi Bioscience Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Emerging Therapies for Hepatocellular Carcinoma (HCC).
    Chakraborty E, Sarkar D. · · 2022 · cited 236× · PMID 35681776 · DOI 10.3390/cancers14112798
  2. Hepatocellular Carcinoma Immune Landscape and the Potential of Immunotherapies.
    Giraud J, Chalopin D, Blanc JF, Saleh M. · · 2021 · cited 172× · PMID 33815418 · DOI 10.3389/fimmu.2021.655697
  3. Advances in drug development for hepatocellular carcinoma: clinical trials and potential therapeutic targets.
    Luo XY, Wu KM, He XX. · · 2021 · cited 144× · PMID 34006331 · DOI 10.1186/s13046-021-01968-w
  4. A review of 2022 Chinese clinical guidelines on the management of hepatocellular carcinoma: updates and insights.
    Xie DY, Zhu K, Ren ZG, Zhou J, et al · · 2023 · cited 117× · PMID 37124695 · DOI 10.21037/hbsn-22-469
  5. [Guidelines for diagnosis and treatment of primary liver cancer in China (2019 edition)].
    Department of Medical Administration, National Health and Health Commission of the People's Republic of China. · · 2020 · cited 116× · PMID 32164061 · DOI 10.3760/cma.j.issn.1007-3418.2020.02.004
  6. Immunotherapy for Hepatocellular Carcinoma: Current Status and Future Prospects.
    Liu Z, Liu X, Liang J, Liu Y, et al · · 2021 · cited 109× · PMID 34675942 · DOI 10.3389/fimmu.2021.765101
  7. Immune Checkpoint Inhibitors in the Treatment of HCC.
    Donisi C, Puzzoni M, Ziranu P, Lai E, et al · · 2020 · cited 105× · PMID 33585218 · DOI 10.3389/fonc.2020.601240
  8. Liver Cancer Immunity.
    Ilyas SI, Wang J, El-Khoueiry AB. · · 2021 · cited 81× · PMID 32516437 · DOI 10.1002/hep.31416

Verify or expand the search:

Other trials of TORIPALIMAB INJECTION(JS001 )

Trials testing the same drug.

Other recruiting trials for Hepatocellular Carcinoma

Currently open trials in the same condition.

Other Shanghai Junshi Bioscience Co., Ltd. trials

Trials by the same sponsor.

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Data sources for this page

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