NCT04103398 (TREAT) is a Phase 3 clinical trial of TACE+sorafenib in Hepatocellular Carcinoma, sponsored by Sun Yat-sen University.

Who is sponsoring NCT04103398?

NCT04103398 is sponsored by Sun Yat-sen University.

What drugs are being tested in NCT04103398?

Interventions in NCT04103398: TACE+sorafenib, TACE.

What condition does NCT04103398 study?

NCT04103398 studies Hepatocellular Carcinoma, Sorafenib, Transarterial Chemoembolization.

Is NCT04103398 still recruiting?

NCT04103398 is currently completed. Last updated 28 February 2024.

Last reviewed 2024-02-28 · How we verify

NCT04103398: TREAT

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

TACE Plus Sorafenib Versus TACE Alone for Recurrent Intermediate Hepatocellular Carcinoma

Completed Phase 3 Last updated 28 February 2024

What this trial tests

Phase 3 trial testing TACE+sorafenib in Hepatocellular Carcinoma in 162 participants. Completed in 31 December 2023.

Timeline

2 October 2019

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	162
Start date	2 October 2019
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across China

Drugs / interventions tested

TACE+sorafenib
TACE

Conditions studied

Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →
Sorafenib — all drugs for Sorafenib →
Transarterial Chemoembolization — all drugs for Transarterial Chemoembolization →

Sponsor

Sun Yat-sen University

Who can join

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

Sponsor's own description

The study is a multicenter phase III randomized trial. The purpose is to investigate both the efficacy and safety of transarterial chemoembolization (TACE) plus sorafenib versus TACE alone for recurrent intermediate hepatocellular carcinoma patients.

Publications & conference data

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

Survival in Patients With Recurrent Intermediate-Stage Hepatocellular Carcinoma: Sorafenib Plus TACE vs TACE Alone Randomized Clinical Trial.
Fan W, Zhu B, Chen S, Wu Y, et al · · 2024 · cited 38× · PMID 38900435 · DOI 10.1001/jamaoncol.2024.1831
Optimizing Survival and the Changing Landscape of Targeted Therapy for Intermediate and Advanced Hepatocellular Carcinoma: A Systematic Review.
Lim H, Ramjeesingh R, Liu D, Tam VC, et al · · 2021 · cited 38× · PMID 32898239 · DOI 10.1093/jnci/djaa119

Verify or expand the search:

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 Sun Yat-sen University trials

Trials by the same sponsor.

NCT07255612 — Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negat · Phase 2 · not yet recruiting
NCT07371897 — Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial · Phase 3 · not yet recruiting
NCT07489703 — SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC · Phase 2 · not yet recruiting
NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
NCT07522281 — Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles · 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 NCT04103398 (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 Sun Yat-sen University
Last refreshed: 28 February 2024

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/NCT04103398.

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