Status:
UNKNOWN
Combine TACE and RFA Versus TACE Alone for HCC With PVTT
Lead Sponsor:
Ming Zhao
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether combined radiofrequency ablation and transcatheter chemoembolization (TACE) result in better survival outcomes than TACE alone in patients with HCC an...
Detailed Description
Hepatocellular carcinoma (HCC) is the sixth most common cancer and the second most common cause of death from cancer globally. Although the development of imaging techniques has improved early HCC dia...
Eligibility Criteria
Inclusion
- HCC with portal vein tumor thrombus in the first or second branch
- Refused sorafenib or could not tolerate the adverse effect of sorafenib
- A solitary HCC ≤ 5.0 cm in diameter, or multiple HCC ≤ 3 lesions, each ≤ 5.0 cm in diameter
- Eastern Cooperative Oncology Group Performance Status 0-1
- Child-Pugh Score ≤ 8
- A platelet counts of \> 60,000/mm3, hemoglobin\>8.5 g/dL, prothrombin time prolong \<6s
- Albumin \>2.8 g/dL, total bilirubin \<51.3 umol/L; alanine aminotransferase (ALT) and aspartate transaminase（AST）\<5 times of upper limit
- Sign the informed consent.
Exclusion
- Presence of extrahepatic metastasis except lymph node metastasis
- The blood supply of tumor lesions is absolutely poor or arterial-venous shunt that TACE can not be performed
- Uncontrolled or refractory ascites, ongoing variceal bleeding or encephalopathy;
- Severe heart, brain or kidney diseases
- Previous or concurrent cancer that is distinct in primary site or histology from HCC
- Pregnant women or lactating women.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2019
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT02301091
Start Date
October 1 2014
End Date
October 1 2019
Last Update
April 14 2016
Active Locations (1)
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1
Minimally Invasive Interventional Division, Medical Imaging Center, Sun Yat-sen University Cancer Center,
Guangzhou, Guangdong, China, 500060