TACE as an Adjuvant Therapy After Hepatectomy for HCC
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|ClinicalTrials.gov Identifier: NCT01966133|
Recruitment Status : Unknown
Verified January 2017 by Jia Fan, Fudan University.
Recruitment status was: Active, not recruiting
First Posted : October 21, 2013
Last Update Posted : January 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Ethiodized Oil + Doxorubicin||Phase 3|
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. The main complications of TACE are liver function damage, mild feverish symptoms, vomit , etc. But most of them are reversible.
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, or microvascular invasion).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomised Controlled Trial on Adjuvant Transarterial Chemoembolisation After Curative Hepatectomy for Hepatocellular Carcinoma|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||August 2017|
No Intervention: Control
no interventions were assigned
Active Comparator: TACE('Ethiodized Oil + Doxorubicin)
TACE using Ethiodized Oil + Doxorubicin mixture was infused through catheter placed at hepatic artery followed by gelfoam embolisation. This is performed 4-6 weeks after surgery.
Drug: Ethiodized Oil + Doxorubicin
TACE using doxorubicin-lipiodol mixture
Other Name: doxorubicin-lipiodol mixture
- Disease-free survival [ Time Frame: 3 years after operation ]
- Overall Survival [ Time Frame: 3-year after surgery ]
- Complications of transarterial chemoembolisation [ Time Frame: 3-month after transarterial chemoembolisation ]
- Health-related quality of life assessment [ Time Frame: 1-year after surgery ]The quality of life assessment was measured by Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire (Chinese version 3)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966133
|Shanghai, Shanghai, China, 200032|
|Principal Investigator:||Jia Fan, MD||Liver cancer institute, Fudan university|
|Study Director:||Jian Zhou, MD||Liver Cancer Institute, Zhong Shan Hospital, Fudan University|