Systemic Chemotherapy Versus Transcatheter Arterial Chemoembolization(TACE) for Hepatocellular Carcinoma

Last updated: June 1, 2019
Sponsor: Guangxi Medical University
Overall Status: Trial Not Available

Phase

2/3

Condition

Carcinoma

Liver Cancer

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT02585479
TA-C/Ahcc
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to determine that systemic chemotherapy is superior to transcatheter arterial chemoembolization in prolonging progression-free survival(PFS) in patients with Advanced Hepatocellular Carcinoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eligible patients were age 18 to 75 years;

  • The patients had histologically, cytologically,or clinically diagnosed unresectableHCC;and were ineligible for local invasive treatment. Clinically diagnosed patientshad to have: (1) evidence of HBV or HCV with hepatic cirrhosis; (2) a-fetoproteinlevels 400g/L; and (3) morphologic evidence of hypervascular liver tumor. Patients hadto have at least one measurable lesion according to RECIST (version 1.0; ≥2 cm oncomputed tomography [CT]; 1 cm on spiral CT or magnetic resonance imaging). Lesionsthat had undergone previous interventional or local therapy were not consideredmeasurable lesions.

  • ECOG score≤2;

  • life expectancy 3 months;

  • Barcelona Clinic liver cancer (BCLC) stage B or C disease;

  • Child-Pugh stage A or B disease;

  • Adequate organ and marrow function, with neutrophil count≥1.5X10e9/L, plateletcount≥75×10e9/L, AST or ALT﹤2.5×upper limit of normal (ULN), total bilirubin

<1.5×ULN, international normalized ratio <1.5;normal baseline left ventricularejection fraction_lower limit of normal for the institution. Patients with AST andALT<5 ×ULN could be recruited if total bilirubin was in the normal range.

  • Patients had to provide signed informed consent to participate.

Exclusion

Exclusion Criteria:

  • documented allergy to lipoidal or other study drugs; any previous treatment beforerandom assignment;

  • Previous liver transplantation;

  • concomitant use of any other anticancer therapy, including interferon alfa and herbalmedicine approved by the local authority to be used as anticancer medicine (exceptpalliative radiotherapy to a nontarget lesion);

  • CNS metastasis;

  • Other serious illness or medical condition.

Study Design

Study Start date:
October 01, 2015
Estimated Completion Date:
October 31, 2017