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NCT04181931: NeoconceptC

Neo-TACE-HAIC for PVTT-HCC

Status unknown NA Last updated 26 October 2020
What this trial tests

NA trial testing neo-TACE-HAIC+Surgery in Hepatocellular Carcinoma in 320 participants. Status unknown.

Timeline
16 December 2019
Primary endpoint
30 December 2022
30 December 2024

Quick facts

Lead sponsorSun Yat-sen University
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment320
Start date16 December 2019
Primary completion30 December 2022
Estimated completion30 December 2024
Sites2 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Sun Yat-sen University

Who can join

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

Sponsor's own description

Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. During the disease course, 20%-50% patients suffered portal vein tumor thrombus (PVTT), which is characterized with poor outcome and low response for treatments. Although BCLC (Barcelona clinical liver cancer) system recommend to palliative targeted treatment, the East Asian countries recommend to resection or transartery chemoembolization (TACE). Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for advanced HCC. Pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate. Whether TACE-HAIC would improve survival for patients with PVTT is need to further to study. A randomized clinical trial compared neo-TACE-HAIC with surgery versus surgery alone is aimed to answer this question.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Hepatic Artery Infusion Chemotherapy for Primary and Secondary Malignancies of the Liver: State of the Art and Current High-Level Evidence.
    Kuemmerli C, Hess V, Dutkowski P, Sinz S, et al · · 2024 · cited 3× · PMID 38368862 · DOI 10.1159/000537887

Verify or expand the search:

Other trials of neo-TACE-HAIC+Surgery

Trials testing the same drug.

Other recruiting trials for Hepatocellular Carcinoma

Currently open trials in the same condition.

Other Sun Yat-sen University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT04181931.

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