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NCT03859128: JUPITER 04
Toripalimab or Placebo as Adjuvant Therapy in Hepatocellular Carcinoma After Radical Resection
Phase 2, PHASE3 trial testing TORIPALIMAB INJECTION(JS001 ) in Hepatocellular Carcinoma in 402 participants. Status unknown.
18 April 2023
Quick facts
| Lead sponsor | Shanghai Junshi Bioscience Co., Ltd. |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 402 |
| Start date | 5 March 2019 |
| Primary completion | 18 April 2023 |
| Estimated completion | 1 August 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- TORIPALIMAB INJECTION(JS001 ) — full drug profile →
Conditions studied
- Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →
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):
-
Emerging Therapies for Hepatocellular Carcinoma (HCC).
Chakraborty E, Sarkar D. · · 2022 · cited 236× · PMID 35681776 · DOI 10.3390/cancers14112798 -
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 -
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 -
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 -
[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 -
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 -
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 -
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:
- PubMed search for NCT03859128
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of TORIPALIMAB INJECTION(JS001 )
Trials testing the same drug.
- NCT06919848 — Oncolytic Virus H101 Combined With Lenvatinib Plus Toripalimab Compared With FOLFOX in Patients With Advanced Biliary Tr · Phase 2 · not yet recruiting
- NCT06903871 — Toripalimab Adjuvant Therapy in Subjects With Resected Esophageal Squamous Cell Carcinoma Who Achieved Pathological Comp · Phase 2 · not yet recruiting
- NCT06705127 — Radiotherapy Followed by Chemotherapy Combined With Toripalimab in Local Advanced HR-positive,HER2-negative BC. · Phase 2 · recruiting
- NCT03924050 — Toripalimab Plus Pemetrexed+Platinus in Advanced Non-small-cell Lungcancer Patients Previsouly Treated EGFR-TKI · Phase 3 · unknown
- NCT06889649 — SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC · Phase 2 · recruiting
Other recruiting trials for Hepatocellular Carcinoma
Currently open trials in the same condition.
- NCT06902246 — Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma · Phase 2 · recruiting
- NCT05842174 — Targeting Ischemia-Induced Autophagy Dependence in Hepatocellular Carcinoma · Phase 1, PHASE2 · recruiting
- NCT07417397 — Adjuvant TACE in HCC With High-risk Recurrence Factors · Phase 3 · recruiting
- NCT07317414 — β-alanine in the Treatment of Advanced Hepatocellular Carcinoma · Phase 2 · recruiting
- NCT07148050 — Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimer · Phase 1 · recruiting
Other Shanghai Junshi Bioscience Co., Ltd. trials
Trials by the same sponsor.
- NCT07503756 — JS212 Combination Therapies in Metastatic Colorectal Cancer · Phase 2 · not yet recruiting
- NCT07480733 — Phase II Study of JS212/JS213 as Monotherapy and in Combination in Patients With Advanced Malignant Solid Tumors · Phase 2 · not yet recruiting
- NCT07484724 — A Study Evaluating the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Ce · Phase 2 · not yet recruiting
- NCT07518160 — JS212 Plus JS111 in EGFR-Mutant Advanced NSCLC: A Phase II Study · Phase 2 · not yet recruiting
- NCT07309276 — A Phase II Clinical Study Evaluating the Combination Therapy of JS212 in Patients With Advanced Lung Cancer · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03859128 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Junshi Bioscience Co., Ltd.
- Last refreshed: 31 March 2023
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