Efficacy Study of TACE to Treat Hepatocellular Carcinoma After Operation
Post-hepatectomy Adjuvant Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Patients With Preoperative CTC Level ≥2: a Multicenter Randomized Controlled Trial in China
1 other identifier
interventional
256
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2015
Longer than P75 for phase_4
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 9, 2015
CompletedFirst Posted
Study publicly available on registry
December 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedDecember 22, 2015
December 1, 2015
3 years
December 9, 2015
December 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Early recurrence rates
Early recurrence was defined as any type of recurrence diagnosed within 1 year after hepatectomy.
1 year after hepatectomy
Secondary Outcomes (1)
Overall Survival
up to 3 years
Study Arms (2)
Adjuvant TACE
EXPERIMENTALTACE will be performed 4-6 weeks after hepatectomy in patients with preoperative CTC ≥2 Epirubicin, lipiodol and gelatin sponge articles are used in TACE.
Control
NO INTERVENTIONno interventions were assigned after hepatectomy
Interventions
TACE is performed 4-6 weeks after hepatectomy. Epirubicin and lipiodol are used in TACE.
lipiodol is a kind of embolization material used in TACE
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
- Shanghai Zhongshan Hospitalcollaborator
- Johnson & Johnson Medical, Chinacollaborator
Study Sites (6)
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510000, China
Nantong Tumor Hospital
Nantong, Jiangsu, 226000, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000, China
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Shanghai, Shanghai Municipality, 200000, China
Xinhua Hospital, Affliated with Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai Municipality, 200000, China
Zhongshan hospital, Fudan University
Shanghai, Shanghai Municipality, 200000, China
Related Publications (3)
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.
PMID: 23175471BACKGROUNDZhong 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: 19408012BACKGROUNDRen 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.
PMID: 15334671BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jia Fan, MD & PhD
Shanghai Zhongshan Hospital, Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- President of Shanghai Zhongshan Hospital
Study Record Dates
First Submitted
December 9, 2015
First Posted
December 16, 2015
Study Start
December 1, 2015
Primary Completion
December 1, 2018
Study Completion
December 1, 2019
Last Updated
December 22, 2015
Record last verified: 2015-12