NCT05582109 is a Phase 2 clinical trial of Envafolimab, Lenvatinib Combined With TACE in Objective Response Rate (ORR), sponsored by Tianjin Medical University Cancer Institute and Hospital.

Who is sponsoring NCT05582109?

NCT05582109 is sponsored by Tianjin Medical University Cancer Institute and Hospital.

What drugs are being tested in NCT05582109?

Interventions in NCT05582109: Envafolimab, Lenvatinib Combined With TACE.

What condition does NCT05582109 study?

NCT05582109 studies Objective Response Rate (ORR).

Is NCT05582109 still recruiting?

NCT05582109 is currently status unknown. Last updated 17 October 2022.

Last reviewed 2022-10-17 · How we verify

NCT05582109

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

Envafolimab, Lenvatinib Combined With TACE in the Treatment of Unresectable Locally Advanced Hepatocellular Carcinoma

Status unknown Phase 2 Last updated 17 October 2022

What this trial tests

Phase 2 trial testing Envafolimab, Lenvatinib Combined With TACE in Objective Response Rate (ORR) in 30 participants. Status unknown.

Timeline

30 October 2022

Primary endpoint
30 October 2023

30 October 2025

Quick facts

Lead sponsor	Tianjin Medical University Cancer Institute and Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	30 October 2022
Primary completion	30 October 2023
Estimated completion	30 October 2025

Drugs / interventions tested

Envafolimab, Lenvatinib Combined With TACE — full drug profile →

Conditions studied

Objective Response Rate (ORR) — all drugs for Objective Response Rate (ORR) →

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Who can join

18 and older, any sex, with Objective Response Rate (ORR). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

TACE lays a theoretical foundation for synergistic enhancement in combination with PD-1/PD-L1 immunosuppressive agents by reducing tumor burden and peripheral blood treg, improving the immune status of patients, reducing immune tolerance, and enhancing anti-tumor effects. TACE then causes locally treated tumor cell death and releases tumor-specific antigens, which further induce tumor-associated antigen-specific responses due to this immunogenic cell death (ICD), thereby activating the immune system to attack tumor cells. This is a single-arm, open-label, exploratory clinical study to evaluate the efficacy and safety of Envafolimab, Lenvatinib combined with TACE in the treatment of unresectable locally advanced hepatocellular carcinoma.

Publications & conference data

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

Immunogenic cell death-based cancer vaccines: promising prospect in cancer therapy.
Wang J, Ma J, Xie F, Miao F, et al · · 2024 · cited 19× · PMID 38745666 · DOI 10.3389/fimmu.2024.1389173
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

Verify or expand the search:

Other Tianjin Medical University Cancer Institute and Hospital trials

Trials by the same sponsor.

NCT07493993 — Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Nab-Paclitaxel in Neoa · Phase 2 · not yet recruiting
NCT07515469 — A Prospective, Single-Arm, Exploratory Study of the Safety and Efficacy of Neoadjuvant Treatment With QL1706, an Anti-PD · Phase 2 · not yet recruiting
NCT07475026 — A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence · Phase 3 · not yet recruiting
NCT07510594 — A Phase II Study of Benmelstobart + Anlotinib + Chemotherapy as First-Line Treatment for LCNEC and EP-NEC · Phase 2 · not yet recruiting
NCT07528274 — Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure · 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 NCT05582109 (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 Tianjin Medical University Cancer Institute and Hospital
Last refreshed: 17 October 2022

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/NCT05582109.

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