HAIC Versus TACE for Large Hepatocellular Carcinoma Staged BCLC A/B.

Last updated: June 8, 2023
Sponsor: Sun Yat-sen University
Overall Status: Completed

Phase

3

Condition

Liver Cancer

Digestive System Neoplasms

Carcinoma

Treatment

TACE Drug Protocol

Hepatic arterial infusion chemotherapy

Folfox Protocol

Clinical Study ID

NCT02973685
HCC-S023
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with large hepatocellular carcinoma staged BCLC A/B.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age range from 18-75 years;
  • KPS≥70;
  • The diagnosis of HCC was based on the diagnostic criteria for HCC used by the EuropeanAssociation for the Study of the Liver (EASL), simultaneously staged as BCLC A or BCLCB based on Barcelona Clinic Liver Cancer staging system.
  • Patients must have at least one tumor lesion that can be accurately measured;
  • The sum of diameters of all lesions longer than 10 cm with the maximum lesion longerthan 7 cm.
  • Diagnosed as unresectable with consensus by the panel of liver surgery experts;
  • Re commanded treated by TAI or TACE with consensus by the panel of liver MDT;
  • No past history of TACE, TAI, chemotherapy or molecule-targeted treatment;
  • No Cirrhosis or cirrhotic status of Child-Pugh class A only
  • Meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL;(b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin ≥ 32 g/L;(e) ASL and AST ≤ 6 x upper limit of normal;(f) Serum creatinine ≤ 1.5 x upper limit of normal;(g) INR > 2.3 or PT/APTT within normal limits;(h) Absolute neutrophil count (ANC) >1,500/mm3;
  • Ability to understand the protocol and to agree to and sign a written informed consentdocument.

Exclusion

Exclusion Criteria:

  • Patients with clinically significant gastrointestinal bleeding within 30 days prior tostudy entry.
  • Known of serious heart disease which can nor endure the treatment such as cardiacventricular arrhythmias requiring anti-arrhythmic therapy
  • Evidence of hepatic decompensation including ascites, gastrointestinal bleeding orhepatic encephalopathy
  • Known history of HIV
  • History of organ allograft
  • Known or suspected allergy to the investigational agents or any agent given inassociation with this trial.
  • Evidence of bleeding diathesis.
  • Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose ofstudy drug
  • Serious non-healing wound, ulcer, or bone fracture
  • Known central nervous system tumors including metastatic brain disease
  • Poor compliance that can not comply with the course of treatment and follow up.

Study Design

Total Participants: 315
Treatment Group(s): 4
Primary Treatment: TACE Drug Protocol
Phase: 3
Study Start date:
October 01, 2016
Estimated Completion Date:
November 28, 2020

Study Description

Transarterial chemoembolization (TACE) is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients. While a number of studies demonstrate poor effect of TACE for patients with large hepatocellular carcinoma staged BCLC A/B especially for those with tumor larger than 10 cm. Our previous prospective study also revealed similar results of large HCC patients treated with TACE. Recently, the results of our preliminary pilot study suggested that, compared with TACE, hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for HCC with large HCC. Thus, the investigators carried out this prospective randomized control to demonstrate the superiority of HAIC over TACE.

Connect with a study center

  • Dongguan People's Hospital

    Dongguan, Guangdong 523059
    China

    Site Not Available

  • The First People's Hospital of Foshan

    Foshan, Guangdong 510060
    China

    Site Not Available

  • Cancer Center Sun Yat-sen University

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • Guangzhou Twelfth People's Hospital

    Guangzhou, Guangdong 510620
    China

    Site Not Available

  • Kaiping Central Hospital

    Kaiping, Guangdong 529300
    China

    Site Not Available

  • The First Affiliated Hospital of University Of South China

    Hengyang, Hunan 421001
    China

    Site Not Available

  • The First Affiliated Hospital Of Xi'an Jiaotong University

    Xi'an, Shanxi 710061
    China

    Site Not Available

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