HAIC of FOLFOX vs. HAIC of OXA for Advanced HCC

Last updated: March 11, 2018
Sponsor: Sun Yat-sen University
Overall Status: Trial Status Unknown

Phase

3

Condition

Liver Cancer

Cancer/tumors

Cancer

Treatment

N/A

Clinical Study ID

NCT03468231
HCC-20180309
  • 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) of oxaliplatin plus fluorouracil/leucovorin compared with HAIC of oxaliplatin alone in patients with hepatocellular carcinoma (HCC) with major portal venous tumor thrombus (PVTT).

Eligibility Criteria

Inclusion

Inclusion Criteria: The diagnosis of HCC was based on the diagnostic criteria for HCC used by the EuropeanAssociation for the Study of the Liver (EASL)

  • Patients must have at least one tumor lesion that can be accurately measured accordingto EASL criteria.

  • diagnosed with major or main portal vein invasion (Vp3 or Vp4)

  • KPS≥70;

  • with no previous treatment

  • No Cirrhosis or cirrhotic status of Child-Pugh class A only

  • Not amendable to surgical resection ,local ablative therapy and any other curedtreatment.

  • The following laboratory parameters:

  • Platelet count ≥ 75,000/µL

  • Hemoglobin ≥ 8.5 g/dL

  • Total bilirubin ≤ 30mmol/L

  • Serum albumin ≥ 30 g/L

  • ASL and AST ≤ 5 x upper limit of normal

  • Serum creatinine ≤ 1.5 x upper limit of normal

  • INR ≤ 1.5 or PT/APTT within normal limits

  • 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:

  • 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.

  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

  • Evidence of bleeding diathesis.

  • Patients with clinically significant gastrointestinal bleeding within 30 days prior tostudy entry.

  • 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

Study Design

Total Participants: 300
Study Start date:
March 09, 2018
Estimated Completion Date:
March 09, 2020

Study Description

Sorafenib is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients with portal venous tumor thrombus (PVTT). Our previous prospective study revealed that sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin plus fluorouracil/leucovorin confer a survival benefit to HCC with major PVTT. However, HAIC of fluorouracil is not such for advanced HCC. Whether HAIC of oxaliplatin is as effective as HAIC of oxaliplatin plus fluorouracil/leucovorin is controversial. Thus, the investigators carried out this prospective randomized control study to find out it.

Connect with a study center

  • Dongguan People's Hospital

    Dongguan, Guangdong 523059
    China

    Active - Recruiting

  • Cancer Center Sun Yat-sen University

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

  • Guangzhou Twelfth People 's Hospital

    Guangzhou, Guangdong 510620
    China

    Active - Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

  • Kaiping Central Hospital

    Kaiping, Guangdong 529300
    China

    Active - Recruiting

  • First Affiliated Hospital of University Of South China

    Hengyang, Hunan 421001
    China

    Active - Recruiting

  • The First Affiliated Hospital Of Xi'an Jiaotong University

    Xi'an, Shanxi 710061
    China

    Active - Recruiting

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