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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02585479
• Other study ID #: TA-C/Ahcc
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: October 2015
• Est. completion date: October 2017

Study information

• Verified date: June 2019
• Source: Guangxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Pirarubicin
Pirarubicin 30mg/m2 intravenously Pirarubicin17mg/m2 are infused through the right and left hepatic arteries
• Oxaliplatin
Oxaliplatin 100 mg/m2 intravenously Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries
• Lipiodol
Lipiodol 5-10ml infused through the right and left hepatic arteries

Device:
• Gelfoam
Hepatic artery embolization with Gelfoam.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangxi Medical University

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free-Survival		3 months
Secondary	Objective response rate		3 months
Secondary	Overall survival		6 months and 12 months
Secondary	Time-to-Progression		3 months
Secondary	Time-to-Progression within liver		3 months
Secondary	Time-to-Progression outside the liver		3 months