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

NCT02585479 | Withdrawn Phase 2 DMC

• 1 other identifier: TA-C/Ahcc
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Progression-Free-Survival

  3 months

Secondary Outcomes (5)

• Objective response rate

  3 months

• Overall survival

  6 months and 12 months

• Time-to-Progression

  3 months

• Time-to-Progression within liver

  3 months

• Time-to-Progression outside the liver

  3 months

Study Arms (2)

systemic chemotherapy

EXPERIMENTAL

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; Drug: Oxaliplatin

Transcatheter Arterial Chemoembolization

ACTIVE COMPARATOR

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; Drug: Oxaliplatin; Drug: Lipiodol; Device: Gelfoam

Interventions

Pirarubicin DRUG

1. Pirarubicin 30mg/m2 intravenously 2. Pirarubicin17mg/m2 are infused through the right and left hepatic arteries

Transcatheter Arterial Chemoembolization; systemic chemotherapy

Oxaliplatin DRUG

1. Oxaliplatin 100 mg/m2 intravenously 2. Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries

Also known as: Eloxatin

Transcatheter Arterial Chemoembolization; systemic chemotherapy

Lipiodol DRUG

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

Transcatheter Arterial Chemoembolization

Gelfoam DEVICE

Hepatic artery embolization with Gelfoam.

Transcatheter Arterial Chemoembolization

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangxi Medical University: lead

Related Publications (3)

• 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.

  PMID: 23980077 BACKGROUND

• 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.

  PMID: 15555291 BACKGROUND

• 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.

  PMID: 19453695 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

pirarubicin; Oxaliplatin; Ethiodized Oil; Gelatin Sponge, Absorbable

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Iodized Oil; Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures; Surgical Sponges; Surgical Equipment; Equipment and Supplies

Study Officials

• Lequn Li, PhD

  Affiliated Tumor Hospital, Guangxi Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 23, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: June 4, 2019

Record last verified: 2019-06