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

NCT ID: NCT02585479

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-10-31

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pirarubicin

Intervention Type: DRUG

1. Pirarubicin 30mg/m2 intravenously

2. Pirarubicin17mg/m2 are infused through the right and left hepatic arteries

Oxaliplatin

Intervention Type: DRUG

1. Oxaliplatin 100 mg/m2 intravenously

2. Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries

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.

Group Type: ACTIVE_COMPARATOR

Pirarubicin

Intervention Type: DRUG

1. Pirarubicin 30mg/m2 intravenously

2. Pirarubicin17mg/m2 are infused through the right and left hepatic arteries

Oxaliplatin

Intervention Type: DRUG

1. Oxaliplatin 100 mg/m2 intravenously

2. Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries

Lipiodol

Intervention Type: DRUG

Lipiodol 5-10ml infused through the right and left hepatic arteries

Gelfoam

Intervention Type: DEVICE

Hepatic artery embolization with Gelfoam.

Interventions

Pirarubicin

1. Pirarubicin 30mg/m2 intravenously

2. Pirarubicin17mg/m2 are infused through the right and left hepatic arteries

Intervention Type: DRUG

Oxaliplatin

1. Oxaliplatin 100 mg/m2 intravenously

2. Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries

Intervention Type: DRUG

Lipiodol

Lipiodol 5-10ml infused through the right and left hepatic arteries

Intervention Type: DRUG

Gelfoam

Hepatic artery embolization with Gelfoam.

Intervention Type: DEVICE

Other Intervention Names

Eloxatin

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangxi Medical University

OTHER

Sponsor Role: lead

Responsible Party

Chengcheng Liao

Director, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lequn Li, PhD

Role: STUDY_DIRECTOR

Affiliated Tumor Hospital, Guangxi Medical University

References

Qin S, Bai Y, Lim HY, Thongprasert S, Chao Y, Fan J, Yang TS, Bhudhisawasdi V, Kang WK, Zhou Y, Lee JH, Sun Y. Randomized, multicenter, open-label study of oxaliplatin plus fluorouracil/leucovorin versus doxorubicin as palliative chemotherapy in patients with advanced hepatocellular carcinoma from Asia. J Clin Oncol. 2013 Oct 1;31(28):3501-8. doi: 10.1200/JCO.2012.44.5643. Epub 2013 Aug 26.

Reference Type: BACKGROUND

PMID: 23980077 (View on PubMed)

Li L, Sun F, Chen AJ, Li XY, Hu MD, Ran JH, Tang JH. [Capecitabine combined with TACE for advanced liver cancer]. Zhonghua Zhong Liu Za Zhi. 2004 Sep;26(9):565-6. Chinese.

Reference Type: BACKGROUND

PMID: 15555291 (View on PubMed)

Mabed M, Esmaeel M, El-Khodary T, Awad M, Amer T. A randomized controlled trial of transcatheter arterial chemoembolization with lipiodol, doxorubicin and cisplatin versus intravenous doxorubicin for patients with unresectable hepatocellular carcinoma. Eur J Cancer Care (Engl). 2009 Sep;18(5):492-9. doi: 10.1111/j.1365-2354.2008.00984.x.

Reference Type: BACKGROUND

PMID: 19453695 (View on PubMed)

Other Identifiers

TA-C/Ahcc

Identifier Type: -

Identifier Source: org_study_id