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

Phase 2

Withdrawn

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Pirarubicin; Drug: Oxaliplatin; Drug: Lipiodol; Device: Gelfoam

• Registration Number: NCT02585479
• Lead Sponsor: Guangxi Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-22
• Study First Posted: 2015-10-23
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-01
• Last Update Posted: 2019-06-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcatheter Arterial Chemoembolization	Gelfoam	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.
systemic chemotherapy	Pirarubicin	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.
systemic chemotherapy	Oxaliplatin	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.
Transcatheter Arterial Chemoembolization	Pirarubicin	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.
Transcatheter Arterial Chemoembolization	Lipiodol	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.
Transcatheter Arterial Chemoembolization	Oxaliplatin	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.

Primary Outcome Measures

Name	Time	Method
Progression-Free-Survival	3 months

Secondary Outcome Measures

Name	Time	Method
Objective response rate	3 months
Time-to-Progression	3 months
Time-to-Progression within liver	3 months
Time-to-Progression outside the liver	3 months
Overall survival	6 months and 12 months