Adjuvant Transcatheter Arterial Chemoembolization Versus Adjuvant Systemic Chemotherapy for Hepatocellular Carcinoma

Phase 2

Withdrawn

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Transcatheter Arterial Chemoembolization; Drug: systemic chemotherapy

• Registration Number: NCT02584556
• Lead Sponsor: Guangxi Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-21
• Study First Posted: 2015-10-22
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-01
• Last Update Posted: 2019-06-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. a preoperative diagnosis of HCC with no previous treatment;
2. compensated cirrhosis with Child-Pugh class A, B or no cirrhosis;
3. 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;
4. 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.
5. 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.

Exclusion Criteria

1. documented allergy to study drugs; any previous TACE or systemic chemotherapy treatment before random assignment;
2. 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);
3. CNS metastasis;
4. Other serious illness or medical condition.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcatheter Arterial Chemoembolization	Transcatheter Arterial Chemoembolization	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).
systemic chemotherapy	systemic chemotherapy	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).

Primary Outcome Measures

Name	Time	Method
recurrence free survival	6 months

Secondary Outcome Measures

Name	Time	Method
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