Adjuvant Transcatheter Arterial Chemoembolization Versus Adjuvant Systemic Chemotherapy for Hepatocellular Carcinoma

NCT02584556 | Withdrawn Phase 2 DMC

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

Brief Summary

The purpose of this study is to determine that adjuvant systemic chemotherapy is superior to adjuvant transcatheter arterial chemoembolization(TACE) in prolonging recurrence free survival（RFS） in patients after radical resection of hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• recurrence free survival

  6 months

Secondary Outcomes (4)

• Overall survival

  3 months and 24 months

• Time to Recurrence

  6 months and 12 months

• Time to Recurrence within liver

  3 months and 12 months

• Time of tumor distant metastasis

  3 months and 12 months

Study Arms (2)

systemic chemotherapy

EXPERIMENTAL

Pirarubicin(Brand Name:Pirarubicin - Main Luck Pharmaceutical, China) 30mg/m2 intravenously on Day 1 and Oxaliplatin(Brand Name: Eloxatin) 100 mg/m2 intravenously on Day 2 every 3 weeks within 4-6 weeks after hepatic resection(a total of 4 cycles).

Drug: systemic chemotherapy

Transcatheter Arterial Chemoembolization

ACTIVE COMPARATOR

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 gelatin sponge particles(Gelfoam; Guangzhou)) within 4-6 weeks after hepatic resection(a total of 1 cycle).

Drug: Transcatheter Arterial Chemoembolization

Interventions

systemic chemotherapy DRUG

Pirarubicin(Brand Name:Pirarubicin - Main Luck Pharmaceutical, China) 30mg/m2 intravenously on Day 1 and Oxaliplatin(Brand Name: Eloxatin) 100 mg/m2 intravenously on Day 2 every 3 weeks starting 4-6 weeks after hepatic resection.

systemic chemotherapy

Transcatheter Arterial Chemoembolization DRUG

Lipiodol 5-10ml,Pirarubicin17mg/m2 and Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries,followed by embolization using gelatin sponge particles(Gelfoam; Guangzhou) starting 4-6 weeks after hepatic resection.

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:

• a preoperative diagnosis of HCC with no previous treatment;
• compensated cirrhosis with Child-Pugh class A, B or no cirrhosis;
• multiple tumors more than 5 cm or tumor involving a major branch (the Wrstor second branch) of the portal or hepatic vein(s) on preoperative investigations, and on intraoperative ultrasonography and gross examination of the liver during operation;
• on exploration and intraoperative ultrasonography, the tumor with multiple lesions localized in right or left hemiliver,or the main tumor localized in one lobe only with a small solitary lesion in contralateral lobe, or tumor involving a major branch (the Wrst or second branch) of the portal or hepatic vein(s), which could be safely resected without grossly remaining tumors, and the patient was judged to have well preserved liver function to survive the operation.
• 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.

You may not qualify if:

• documented allergy to study drugs; any previous TACE or systemic chemotherapy treatment before random assignment;
• 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)

• Zhong C, Guo RP, Li JQ, Shi M, Wei W, Chen MS, Zhang YQ. A randomized controlled trial of hepatectomy with adjuvant transcatheter arterial chemoembolization versus hepatectomy alone for Stage III A hepatocellular carcinoma. J Cancer Res Clin Oncol. 2009 Oct;135(10):1437-45. doi: 10.1007/s00432-009-0588-2. Epub 2009 May 1.

  PMID: 19408012 BACKGROUND

• Peng BG, He Q, Li JP, Zhou F. Adjuvant transcatheter arterial chemoembolization improves efficacy of hepatectomy for patients with hepatocellular carcinoma and portal vein tumor thrombus. Am J Surg. 2009 Sep;198(3):313-8. doi: 10.1016/j.amjsurg.2008.09.026. Epub 2009 Mar 12.

  PMID: 19285298 BACKGROUND

• 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

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Neoadjuvant Therapy

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)

Combined Modality Therapy; Therapeutics

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: PREVENTION
• 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 22, 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