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

June 1, 2019 updated by: Chengcheng Liao, Guangxi Medical University

Systemic Chemotherapy VersusTranscatheter Arterial Chemoembolization As Palliative Chemotherapy in Patients With Advanced Hepatocellular Carcinoma(HCC)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Eligible patients were age 18 to 75 years;
  • The patients had histologically, cytologically,or clinically diagnosed unresectable HCC;and were ineligible for local invasive treatment. Clinically diagnosed patients had to have: (1) evidence of HBV or HCV with hepatic cirrhosis; (2) a-fetoprotein levels 400g/L; and (3) morphologic evidence of hypervascular liver tumor. Patients had to have at least one measurable lesion according to RECIST (version 1.0; ≥2 cm on computed tomography [CT]; 1 cm on spiral CT or magnetic resonance imaging). Lesions that had undergone previous interventional or local therapy were not considered measurable 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, platelet count≥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 ventricular ejection fraction_lower limit of normal for the institution. Patients with AST and ALT<5 ×ULN could be recruited if total bilirubin was in the normal range.
  • Patients had to provide signed informed consent to participate.

Exclusion Criteria:

  • documented allergy to lipoidal or other study drugs; any previous treatment before random assignment;
  • Previous liver transplantation;
  • concomitant use of any other anticancer therapy, including interferon alfa and herbal medicine approved by the local authority to be used as anticancer medicine (except palliative radiotherapy to a nontarget lesion);
  • CNS metastasis;
  • Other serious illness or medical condition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: systemic chemotherapy
Pirarubicin 30mg/m2 intravenously on Day 1 and Oxaliplatin 100 mg/m2 intravenously on Day 2 every 3 weeks until disease progression or limiting toxicity.
Drug: Pirarubicin
  1. Pirarubicin 30mg/m2 intravenously
  2. Pirarubicin17mg/m2 are infused through the right and left hepatic arteries
Drug: Oxaliplatin
  1. Oxaliplatin 100 mg/m2 intravenously
  2. Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries
Other Names:
  • Eloxatin
Active Comparator: Transcatheter Arterial Chemoembolization
Lipiodol 5-10ml,Pirarubicin17mg/m2 and Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries,followed by embolization using Gelfoam every 4 weeks until disease progression or limiting toxicity.
Drug: Pirarubicin
  1. Pirarubicin 30mg/m2 intravenously
  2. Pirarubicin17mg/m2 are infused through the right and left hepatic arteries
Drug: Oxaliplatin
  1. Oxaliplatin 100 mg/m2 intravenously
  2. Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries
Other Names:
  • Eloxatin
Drug: Lipiodol
Lipiodol 5-10ml infused through the right and left hepatic arteries
Device: Gelfoam
Hepatic artery embolization with Gelfoam.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-Free-Survival
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response rate
Time Frame: 3 months
3 months
Overall survival
Time Frame: 6 months and 12 months
6 months and 12 months
Time-to-Progression
Time Frame: 3 months
3 months
Time-to-Progression within liver
Time Frame: 3 months
3 months
Time-to-Progression outside the liver
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangxi Medical University

Investigators

  • Study Director: Lequn Li, PhD, Affiliated Tumor Hospital, Guangxi Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

October 20, 2015

First Submitted That Met QC Criteria

October 22, 2015

First Posted (Estimate)

October 23, 2015

Study Record Updates

Last Update Posted (Actual)

June 4, 2019

Last Update Submitted That Met QC Criteria

June 1, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TA-C/Ahcc

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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