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Efficacy Study of TACE to Treat Hepatocellular Carcinoma After Operation

Primary Purpose

Carcinoma, Hepatocellular, Neoplastic Cells, Circulating

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
TACE
Epirubicin
lipiodol
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Circulating Tumor Cells, Hepatoectomy, TACE, prognosis, relapse, Chemoembolization, Therapeutic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HCC patients received curative hepatectomy with negative resection margin
  • Age from 18 to 75
  • Child-Pugh class A
  • ASA class I to II
  • ECOG performance status Grade 0 or 1
  • Preoperative CTC level ≥2 per 7.5 ml peripheral blood
  • No residual tumor revealed by hepatic arterial angiography 4-6 weeks after hepatectomy

Exclusion Criteria:

  • Patients diagnosed with other types of malignancies besides HCC
  • Patients receiving concomitant local ablation or previous TACE
  • Main portal vein tumor thrombus extraction during hepatectomy
  • Hepatic arterial angiography before adjuvant TACE treatment reveals residual tumors.
  • Presence of extra-hepatic or lymphatic metastasis
  • Impaired liver function with either clinically detected ascites, hepatic encephalopathy, serum albumin < 25g/L or bilirubin > 50micromol/L
  • Renal impairment with creatinine > 200micromol/L
  • Severe concurrent medical illness persisting > 6 weeks after hepatectomy
  • History of other cancer
  • Hepatic artery anomaly making TACE not possible
  • Allergy to 5-Fluorouracil, Epirubicin or lipiodol
  • Pregnant woman
  • Informed consent not available

Sites / Locations

  • Sun Yat-Sen University Cancer Center
  • Nantong Tumor Hospital
  • The First Affiliated Hospital of Soochow University
  • Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
  • Xinhua Hospital, Affliated with Shanghai Jiao Tong University, School of Medicine
  • Zhongshan hospital, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Adjuvant TACE

Control

Arm Description

TACE will be performed 4-6 weeks after hepatectomy in patients with preoperative CTC ≥2 Epirubicin, lipiodol and gelatin sponge articles are used in TACE.

no interventions were assigned after hepatectomy

Outcomes

Primary Outcome Measures

Early recurrence rates
Early recurrence was defined as any type of recurrence diagnosed within 1 year after hepatectomy.

Secondary Outcome Measures

Overall Survival
OS was defined as the interval from date of HCC resection to death due to any cause.

Full Information

First Posted
December 9, 2015
Last Updated
December 20, 2015
Sponsor
Fudan University
Collaborators
Shanghai Zhongshan Hospital, Johnson & Johnson Medical, China
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1. Study Identification

Unique Protocol Identification Number
NCT02631499
Brief Title
Efficacy Study of TACE to Treat Hepatocellular Carcinoma After Operation
Official Title
Post-hepatectomy Adjuvant Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Patients With Preoperative CTC Level ≥2: a Multicenter Randomized Controlled Trial in China
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
Collaborators
Shanghai Zhongshan Hospital, Johnson & Johnson Medical, China

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to prospectively evaluate whether post-hepatectomy adjuvant transcatheter arterial chemoembolization (TACE) is effective in reducing early recurrence in HCC patients with preoperative CTC ≥2.
Detailed Description
Hepatocellular carcinoma (HCC) is one of the most prevalent malignancies worldwide, and associated morbidity and mortality rates have escalated in recent years. Despite improvements in surveillance and clinical treatment strategies, the prognosis of HCC remains very poor due to high incidence of recurrence and metastasis. Recent clinical studies have provided evidence that circulating tumor cell (CTC) may directly participate in the metastasis cascade in various types of malignancies. The investigators previous data indicated that HCC patients with preoperative CTC levels ≥2 suffered significantly earlier recurrence (within 1 year) than patients with lower levels. However, the benefits of postoperative adjuvant therapies in preventing early recurrence in patients with preoperative CTC ≥2 remain to be elucidated. Transarterial chemoembolisation (TACE) is an effective palliative treatment for HCC. The investigators design a randomised controlled trial evaluating the efficacy of using TACE after hepatectomy to reduce early recurrence rates in HCC patients with preoperative CTC level ≥2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular, Neoplastic Cells, Circulating
Keywords
Circulating Tumor Cells, Hepatoectomy, TACE, prognosis, relapse, Chemoembolization, Therapeutic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
256 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adjuvant TACE
Arm Type
Experimental
Arm Description
TACE will be performed 4-6 weeks after hepatectomy in patients with preoperative CTC ≥2 Epirubicin, lipiodol and gelatin sponge articles are used in TACE.
Arm Title
Control
Arm Type
No Intervention
Arm Description
no interventions were assigned after hepatectomy
Intervention Type
Procedure
Intervention Name(s)
TACE
Other Intervention Name(s)
Transcatheter Arterial Chemoembolization, Chemoembolization
Intervention Description
TACE is performed 4-6 weeks after hepatectomy. Epirubicin and lipiodol are used in TACE.
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Other Intervention Name(s)
EADM
Intervention Description
Epirubicin is a chemotherapy drug used in TACE
Intervention Type
Drug
Intervention Name(s)
lipiodol
Other Intervention Name(s)
Ultra-fluid lipiodol
Intervention Description
lipiodol is a kind of embolization material used in TACE
Primary Outcome Measure Information:
Title
Early recurrence rates
Description
Early recurrence was defined as any type of recurrence diagnosed within 1 year after hepatectomy.
Time Frame
1 year after hepatectomy
Secondary Outcome Measure Information:
Title
Overall Survival
Description
OS was defined as the interval from date of HCC resection to death due to any cause.
Time Frame
up to 3 years

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: HCC patients received curative hepatectomy with negative resection margin Age from 18 to 75 Child-Pugh class A ASA class I to II ECOG performance status Grade 0 or 1 Preoperative CTC level ≥2 per 7.5 ml peripheral blood No residual tumor revealed by hepatic arterial angiography 4-6 weeks after hepatectomy Exclusion Criteria: Patients diagnosed with other types of malignancies besides HCC Patients receiving concomitant local ablation or previous TACE Main portal vein tumor thrombus extraction during hepatectomy Hepatic arterial angiography before adjuvant TACE treatment reveals residual tumors. Presence of extra-hepatic or lymphatic metastasis Impaired liver function with either clinically detected ascites, hepatic encephalopathy, serum albumin < 25g/L or bilirubin > 50micromol/L Renal impairment with creatinine > 200micromol/L Severe concurrent medical illness persisting > 6 weeks after hepatectomy History of other cancer Hepatic artery anomaly making TACE not possible Allergy to 5-Fluorouracil, Epirubicin or lipiodol Pregnant woman Informed consent not available
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin-Rong Yang, MD & PhD
Phone
008618616881978
Email
yang.xinrong@zs-hospital.sh.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yun-Fan Sun, MD & PhD
Phone
008613162601787
Email
yunfan_sun@msn.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia Fan, MD & PhD
Organizational Affiliation
Shanghai Zhongshan Hospital, Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Nantong Tumor Hospital
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226000
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Soochow
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Facility Name
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Xinhua Hospital, Affliated with Shanghai Jiao Tong University, School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Zhongshan hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23175471
Citation
Sun YF, Xu Y, Yang XR, Guo W, Zhang X, Qiu SJ, Shi RY, Hu B, Zhou J, Fan J. Circulating stem cell-like epithelial cell adhesion molecule-positive tumor cells indicate poor prognosis of hepatocellular carcinoma after curative resection. Hepatology. 2013 Apr;57(4):1458-68. doi: 10.1002/hep.26151. Epub 2013 Mar 4.
Results Reference
background
PubMed Identifier
19408012
Citation
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.
Results Reference
background
PubMed Identifier
15334671
Citation
Ren ZG, Lin ZY, Xia JL, Ye SL, Ma ZC, Ye QH, Qin LX, Wu ZQ, Fan J, Tang ZY. Postoperative adjuvant arterial chemoembolization improves survival of hepatocellular carcinoma patients with risk factors for residual tumor: a retrospective control study. World J Gastroenterol. 2004 Oct 1;10(19):2791-4. doi: 10.3748/wjg.v10.i19.2791.
Results Reference
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Efficacy Study of TACE to Treat Hepatocellular Carcinoma After Operation

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