NCT04709380 is a Phase 3 clinical trial of Radiotherapy plus Toripalimab in Radiotherapy, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.

Who is sponsoring NCT04709380?

NCT04709380 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.

What drugs are being tested in NCT04709380?

Interventions in NCT04709380: Radiotherapy plus Toripalimab, Sorafenib.

What condition does NCT04709380 study?

NCT04709380 studies Radiotherapy, Toripalimab, Sorafenib, Advanced Hepatocellular Carcinoma.

Is NCT04709380 still recruiting?

NCT04709380 is currently terminated. Last updated 26 February 2025.

Last reviewed 2025-02-26 · How we verify

NCT04709380

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase III RCT of Radiotherapy Plus Toripalimab Versus Sorafenib in Advanced Hepatocellular Carcinoma With PVTT

Terminated Phase 3 Last updated 26 February 2025

What this trial tests

Phase 3 trial testing Radiotherapy plus Toripalimab in Radiotherapy in 36 participants. Terminated before completion.

Timeline

2 March 2021

Primary endpoint
27 December 2024

5 February 2025

Quick facts

Lead sponsor	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	2 March 2021
Primary completion	27 December 2024
Estimated completion	5 February 2025
Sites	1 location across China

Drugs / interventions tested

Radiotherapy plus Toripalimab
Sorafenib (SORAFENIB) — full drug profile →

Conditions studied

Radiotherapy — all drugs for Radiotherapy →
Toripalimab — all drugs for Toripalimab →
Sorafenib — all drugs for Sorafenib →
Advanced Hepatocellular Carcinoma — all drugs for Advanced Hepatocellular Carcinoma →

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Who can join

Adults 18 to 80, any sex, with Radiotherapy or Toripalimab. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To explore the efficacy of radiotherapy plus toripalimab Versus standard treatment of sorafenib in advanced hepatocellular carcinoma with Portal Vein/Hepatic vein Tumor Thrombosis.

Publications & conference data

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

Hepatocellular carcinoma: signaling pathways and therapeutic advances.
Zheng J, Wang S, Xia L, Sun Z, et al · · 2025 · cited 142× · PMID 39915447 · DOI 10.1038/s41392-024-02075-w
Reshaping the systemic tumor immune environment (STIE) and tumor immune microenvironment (TIME) to enhance immunotherapy efficacy in solid tumors.
Xu L, Zou C, Zhang S, Chu TSM, et al · · 2022 · cited 131× · PMID 35799264 · DOI 10.1186/s13045-022-01307-2
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
Advances in radiotherapy and immunity in hepatocellular carcinoma.
Yang Y, Xiong L, Li M, Jiang P, et al · · 2023 · cited 37× · PMID 37542324 · DOI 10.1186/s12967-023-04386-y
Overcoming resistance to immune checkpoint inhibitors in hepatocellular carcinoma: Challenges and opportunities.
Xie Q, Zhang P, Wang Y, Mei W, et al · · 2022 · cited 26× · PMID 36119533 · DOI 10.3389/fonc.2022.958720
Clinical Trials of Immune Checkpoint Inhibitors in Hepatocellular Carcinoma.
Dyhl-Polk A, Mikkelsen MK, Ladekarl M, Nielsen DL. · · 2021 · cited 14× · PMID 34208788 · DOI 10.3390/jcm10122662
The Role of Immunotherapy in a Tolerogenic Environment: Current and Future Perspectives for Hepatocellular Carcinoma.
Montella L, Sarno F, Ambrosino A, Facchini S, et al · · 2021 · cited 7× · PMID 34440678 · DOI 10.3390/cells10081909
Combination of radiotherapy and ICIs in advanced hepatocellular carcinoma: A systematic review of current evidence and future prospects (Review).
Ma C, Yu X, Zhang X, Su L, et al · · 2025 · cited 4× · PMID 40438865 · DOI 10.3892/ol.2025.15088

Verify or expand the search:

Other recruiting trials for Radiotherapy

Currently open trials in the same condition.

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NCT07447570 — Iparomlimab and Tuvonralimab Plus Hypofractionated Radiotherapy and Chemotherapy for HAHNSCC · Phase 2 · recruiting

Other Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials

Trials by the same sponsor.

NCT07531563 — Protein Supplementation for Radiation- Induced Oral Mucositis in Head and Neck Cancer Patients Receiving Radiotherapy · NA · not yet recruiting
NCT07537049 — BR101 in Patients With Relapsed/Refractory Multiple Myeloma · Phase 1 · not yet recruiting
NCT07187154 — The Application of Symptoms Management Program Based on the Patient Reported Outcome After Esophagectomy · NA · not yet recruiting
NCT07530549 — A Phase II Single-arm Clinical Study in the Treatment of Locally Advanced Esophageal Cancer After Failed Neoadjuvant Che · Phase 2 · not yet recruiting
NCT07507058 — Hypofractionated Radiotherapy for Postoperative Intermediate-Risk Head and Neck Squamous Cell Carcinoma · NA · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04709380 (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 Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Last refreshed: 26 February 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04709380.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing