NCT05608200 is a Phase 3 clinical trial of Lenvatinib, sintilimab plus TACE in Hepatocellular Carcinoma Non-resectable, sponsored by Second Affiliated Hospital of Guangzhou Medical University.

Who is sponsoring NCT05608200?

NCT05608200 is sponsored by Second Affiliated Hospital of Guangzhou Medical University.

What drugs are being tested in NCT05608200?

Interventions in NCT05608200: Lenvatinib, sintilimab plus TACE, Lenvatinib plus TACE.

What condition does NCT05608200 study?

NCT05608200 studies Hepatocellular Carcinoma Non-resectable.

Is NCT05608200 still recruiting?

NCT05608200 is currently recruiting now. Last updated 31 May 2023.

Last reviewed 2023-05-31 · How we verify

NCT05608200

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

Lenvatinib+Sintilimab+TACE vs. Lenvatinib+TACE for Advanced HCC

Recruiting now Phase 3 Last updated 31 May 2023

What this trial tests

Phase 3 trial testing Lenvatinib, sintilimab plus TACE in Hepatocellular Carcinoma Non-resectable in 427 participants. Currently enrolling.

Timeline

2 November 2022

Primary endpoint
31 October 2026

31 October 2026

Quick facts

Lead sponsor	Second Affiliated Hospital of Guangzhou Medical University
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	427
Start date	2 November 2022
Primary completion	31 October 2026
Estimated completion	31 October 2026
Sites	1 location across China

Drugs / interventions tested

Lenvatinib, sintilimab plus TACE — full drug profile →
Lenvatinib plus TACE — full drug profile →

Conditions studied

Hepatocellular Carcinoma Non-resectable — all drugs for Hepatocellular Carcinoma Non-resectable →

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Who can join

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

Sponsor's own description

This study is conducted to evaluate the efficacy and safety of lenvatinib, sintilimab plus TACE (Len-Sin-TACE) compared with lenvatinib plus TACE (Len-TACE) for patients with advanced hepatocellular carcinoma (HCC).

Publications & conference data

6 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
New Opportunities in the Systemic Treatment of Hepatocellular Carcinoma-Today and Tomorrow.
Becht R, Kiełbowski K, Wasilewicz MP. · · 2024 · cited 15× · PMID 38338736 · DOI 10.3390/ijms25031456
Small-molecule-based targeted therapy in liver cancer.
Ming Y, Gong Y, Fu X, Ouyang X, et al · · 2024 · cited 6× · PMID 39113358 · DOI 10.1016/j.ymthe.2024.08.001
Insights in Molecular Therapies for Hepatocellular Carcinoma.
Heumann P, Albert A, Gülow K, Tümen D, et al · · 2024 · cited 5× · PMID 38791911 · DOI 10.3390/cancers16101831
T-cell Receptor Repertoire Analysis in the Context of Transarterial Chemoembolization Synergy with Systemic Therapy for Hepatocellular Carcinoma.
Li J, Zhang Y, Hu L, Ye H, et al · · 2025 · cited 1× · PMID 39801788 · DOI 10.14218/jcth.2024.00238
The State of the Art in Combination Locoregional and Systemic Treatment Strategies for Hepatocellular Carcinoma: Recent Advancements and Future Horizons.
Fazlollahi F, Carfora AD, King M, Wrasman ES, et al · · 2026 · PMID 41892200 · DOI 10.3390/curroncol33030172

Verify or expand the search:

Other recruiting trials for Hepatocellular Carcinoma Non-resectable

Currently open trials in the same condition.

NCT06904183 — Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT · Phase 2 · recruiting
NCT06904196 — Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC · Phase 2 · recruiting
NCT06561399 — Triple Therapy Sequential Radiotherapy in Unresectable HCC (TALENP003) · recruiting
NCT06492395 — Lenvatinib Plus DEB-TACE and HAIC vs. Lenvatinib Plus DEB-TACE for Large HCC With PVTT · Phase 3 · recruiting
NCT06397235 — DEB-TACE+RALOX-HAIC vs DEB-TACE for Large HCC · Phase 2 · recruiting

Other Second Affiliated Hospital of Guangzhou Medical University trials

Trials by the same sponsor.

NCT06966830 — Lacosamide Intravenous Injection for Emergency Termination of Status Epilepticus · not yet recruiting
NCT06936683 — Herpes Simplex Virus Type 1 Infection/Reactivation of Patients With Severe Pneumonia（the HSV-SP Study） · not yet recruiting
NCT07374328 — Triple Hypoglycemic Regimens In Patients With Newly Diagnosed Type 2 Diabetes Mellitus · Phase 1, PHASE2 · recruiting
NCT06904183 — Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT · Phase 2 · recruiting
NCT06904196 — Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC · Phase 2 · 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 NCT05608200 (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 Second Affiliated Hospital of Guangzhou Medical University
Last refreshed: 31 May 2023

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/NCT05608200.

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