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NCT03591705

TACE-HAIC vs. HAIC for Potentially Resectable HCC

Status unknown NA Last updated 22 September 2021
What this trial tests

NA trial testing TACE-HAIC in Potentially Resection in 240 participants. Status unknown.

Timeline
6 July 2018
Primary endpoint
30 December 2023
30 December 2024

Quick facts

Lead sponsorSun Yat-sen University
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment240
Start date6 July 2018
Primary completion30 December 2023
Estimated completion30 December 2024
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Sun Yat-sen University

Who can join

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

Sponsor's own description

Hepatocellular carcinoma (HCC) is one of the most commonly malignant tumors around the world. Hepatic resection or liver transplantation is the radical method to cure the disease. However, due to large tumors, surgical treatment is suitable for early-stage and well-reserved liver function patients. Therefore, in clinical practice, transarterial chemoembolization (TACE) is a preferential and standard treatment of potentially resectable HCC. EACH trial opened the door to FOLFOX-based system chemotherapy for advanced HCC patients. Recently, investigators have showed that hepatic arterial infusion of FOLFOX-based chemotherapy (HAIC) was safe and efficient for HCC patients. Several clinical studies showed that HAIC bring better tumor response rate that the conditional TACE. The combination of TACE with HAIC (TACE-HAIC), theoretically can significantly increase the local doses of chemotherapeutic agents in the liver, reduce the viability of HCC cells and increase the hepatectomy rate. However, this hasn't been verified in clinical application. To identify a more effective and safety way for treating potentially resectable HCC patients, this study is designed to compare the safety and efficacy between HAIC and TACE-HAIC for those patients.

Publications & conference data

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

  1. Conversion to Resectability Using Transarterial Chemoembolization Combined With Hepatic Arterial Infusion Chemotherapy for Initially Unresectable Hepatocellular Carcinoma.
    Li B, Qiu J, Zheng Y, Shi Y, et al · · 2021 · cited 60× · PMID 37636551 · DOI 10.1097/as9.0000000000000057
  2. Neoadjuvant Therapy for Hepatocellular Carcinoma.
    Yin Z, Chen D, Liang S, Li X. · · 2022 · cited 22× · PMID 36068876 · DOI 10.2147/jhc.s357313
  3. 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

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Other trials of TACE-HAIC

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