TACE as an Adjuvant Therapy After Hepatectomy for HCC
Overview[ - collapse ][ - ]
| Purpose | We hypothesise that the use of transarterial chemoembolisation (TACE) after liver resection in patients with hepatocellular carcinoma can eradicate residual cancer cells in the liver and thus improve survival of patients with high risk factors for residual tumor. The aim of this study is to compare the survival of patients with high risk factors for residual tumor undergoing liver resection plus post-operative TACE versus liver resection alone. |
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| Condition | Hepatocellular Carcinoma |
| Intervention | Drug: Ethiodized Oil + Doxorubicin |
| Phase | Phase 3 |
| Sponsor | Jia Fan |
| Responsible Party | Fudan University |
| ClinicalTrials.gov Identifier | NCT01966133 |
| First Received | October 16, 2013 |
| Last Updated | October 22, 2013 |
| Last verified | October 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 16, 2013 |
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| Last Updated Date | October 22, 2013 |
| Start Date | January 2012 |
| Estimated Primary Completion Date | January 2017 |
| Current Primary Outcome Measures | 1-year recurrence rate [Time Frame: 1-year after hepatectomy] [Designated as safety issue: No]The 1-year recurrence rate after hepatectomy in both arms of study were compared |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | TACE as an Adjuvant Therapy After Hepatectomy for HCC |
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| Official Title | Randomised Controlled Trial on Adjuvant Transarterial Chemoembolisation After Curative Hepatectomy for Hepatocellular Carcinoma |
| Brief Summary | We hypothesise that the use of transarterial chemoembolisation (TACE) after liver resection in patients with hepatocellular carcinoma can eradicate residual cancer cells in the liver and thus improve survival of patients with high risk factors for residual tumor. The aim of this study is to compare the survival of patients with high risk factors for residual tumor undergoing liver resection plus post-operative TACE versus liver resection alone. |
| Detailed Description | Liver resection is the mainstay of curative treatment for hepatocellular carcinoma (HCC). However, recurrence is common after surgery and most occurs in the liver, especially for the patients with high risk factors for residual tumor, such as tumors with a diameter more than 5 cm, multiple nodules, and microvascular invasion. Transarterial chemoembolisation (TACE) is an effective palliative treatment for HCC. It involves the infusion of chemotherapeutic agent admixed with iodised oil followed by embolisation of the hepatic arterial flow using small particles. This procedures allows application of smaller dose of chemotherapy concentrated to the liver and thus is well tolerated with minimal side effects. We conduct a randomised controlled trial evaluating the efficacy of using TACE after hepatectomy in HCC patients with high risk factors for residual tumor (tumors with a diameter more than 5 cm, multiple nodules, and microvascular invasion). |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Hepatocellular Carcinoma |
| Intervention | Drug: Ethiodized Oil + Doxorubicin TACE using doxorubicin-lipiodol mixture Other Names: doxorubicin-lipiodol mixture |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Enrolling by invitation |
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| Estimated Enrollment | 120 |
| Estimated Completion Date | January 2017 |
| Estimated Primary Completion Date | January 2015 |
| Eligibility Criteria | Inclusion Criteria: - HCC patients received curative hepatectomy with negative resection margin - Tumors with a diameter more than 5 cm, multiple nodules, and microvascular invasion were defined as high risk factors for residual tumor and used for patient stratification. - Age from 18 to 70 - Child-Pugh class A - ASA class I to III - ECOG performance status Grade 0 or 1 Exclusion Criteria: - Patients receiving concomitant local ablation or previous TACE - Main portal vein tumour thrombus extraction during hepatectomy - Tumour arising from caudate lobe - Presence of extra-hepatic disease - 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 doxorubicin or lipiodol - Pregnant woman - Informed consent not available |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | China |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01966133 |
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| Other Study ID Numbers | LCI-125-009 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Fudan University |
| Study Sponsor | Jia Fan |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Jia Fan, MD Liver cancer institute, Fudan university |
| Verification Date | October 2013 |
Locations[ + expand ][ + ]
| Zhongshan Hospital | Shanghai, Shanghai, China, 200032 |
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