Active Not Recruiting PHASE3 INTERVENTIONAL 2-arm NCT04523493

Phase III Study of Toripalimab（JS001） Combined With Lenvatinib for Advanced HCC

A Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter Phase III Study to Compare Toripalimab Combined With Lenvatinib Versus Placebo Combined With Lenvatinib as the 1st-line Therapy for Advanced HCC

Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Conditions Advanced Hepatocellular Carcinoma (HCC)

Interventions Placebo combined with Lenvatinib Toripalimab combined with Lenvatinib

Updated 14 times since 2020 Last updated: Dec 8, 2025 Started: Jun 29, 2020 Primary completion: Dec 31, 2025 Completion: Sep 1, 2026

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Advanced Hepatocellular Carcinoma (HCC) and is currently ongoing. Shanghai Junshi Bioscience Co., Ltd. leads this study, which shows 14 recorded versions since 2020 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

14 versions recorded

Jan 2026 — Present [monthly]

Active Not Recruiting PHASE3
Sep 2025 — Jan 2026 [monthly]

Active Not Recruiting PHASE3
Aug 2025 — Sep 2025 [monthly]

Active Not Recruiting PHASE3
Mar 2025 — Aug 2025 [monthly]

Active Not Recruiting PHASE3
Sep 2024 — Mar 2025 [monthly]

Active Not Recruiting PHASE3

▶ Show 9 earlier versions

Aug 2024 — Sep 2024 [monthly]

Active Not Recruiting PHASE3
Jul 2024 — Aug 2024 [monthly]

Active Not Recruiting PHASE3
Oct 2023 — Jul 2024 [monthly]

Active Not Recruiting PHASE3
Aug 2023 — Oct 2023 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Dec 2022 — Aug 2023 [monthly]

Recruiting PHASE3
Jun 2022 — Dec 2022 [monthly]

Recruiting PHASE3
Oct 2021 — Jun 2022 [monthly]

Recruiting PHASE3
Jan 2021 — Oct 2021 [monthly]

Recruiting PHASE3
Sep 2020 — Jan 2021 [monthly]

Recruiting PHASE3

First recorded

Jun 2020

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Shanghai Junshi Bioscience Co., Ltd.

Data source: Shanghai Junshi Bioscience Co., Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Dnipro, Ukraine , Gdansk, Poland , Kharkiv, Ukraine , Koszalin, Poland , Krakow, Poland , Kyiv, Ukraine , Lutsk, Ukraine , Milan, Italy , Mysłowice, Poland , Nanjing, China and 11 more locations