Systemic Chemotherapy Versus Transcatheter Arterial Chemoembolization(TACE) for Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pirarubicin
Oxaliplatin
Lipiodol
Gelfoam
Sponsored by

About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
systemic chemotherapy
Transcatheter Arterial Chemoembolization
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Progression-Free-Survival
Secondary Outcome Measures
Objective response rate
Overall survival
Time-to-Progression
Time-to-Progression within liver
Time-to-Progression outside the liver
Full Information
NCT ID
NCT02585479
First Posted
October 20, 2015
Last Updated
June 1, 2019
Sponsor
Guangxi Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02585479
Brief Title
Systemic Chemotherapy Versus Transcatheter Arterial Chemoembolization(TACE) for Hepatocellular Carcinoma
Official Title
Systemic Chemotherapy VersusTranscatheter Arterial Chemoembolization As Palliative Chemotherapy in Patients With Advanced Hepatocellular Carcinoma(HCC)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Withdrawn
Why Stopped
It doesn't meet the requirements of randomized trials
Study Start Date
October 2015 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangxi Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
systemic chemotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Transcatheter Arterial Chemoembolization
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pirarubicin
Intervention Description
Pirarubicin 30mg/m2 intravenously
Pirarubicin17mg/m2 are infused through the right and left hepatic arteries
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Eloxatin
Intervention Description
Oxaliplatin 100 mg/m2 intravenously
Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries
Intervention Type
Drug
Intervention Name(s)
Lipiodol
Intervention Description
Lipiodol 5-10ml infused through the right and left hepatic arteries
Intervention Type
Device
Intervention Name(s)
Gelfoam
Intervention Description
Hepatic artery embolization with Gelfoam.
Primary Outcome Measure Information:
Title
Progression-Free-Survival
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Objective response rate
Time Frame
3 months
Title
Overall survival
Time Frame
6 months and 12 months
Title
Time-to-Progression
Time Frame
3 months
Title
Time-to-Progression within liver
Time Frame
3 months
Title
Time-to-Progression outside the liver
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lequn Li, PhD
Organizational Affiliation
Affiliated Tumor Hospital, Guangxi Medical University
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
23980077
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.
Results Reference
background
PubMed Identifier
15555291
Citation
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.
Results Reference
background
PubMed Identifier
19453695
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.
Results Reference
background
Learn more about this trial
Systemic Chemotherapy Versus Transcatheter Arterial Chemoembolization(TACE) for Hepatocellular Carcinoma
We'll reach out to this number within 24 hrs