Status:
UNKNOWN
Microwave Ablation Combined With TACE in the Treatment of Unresectable Huge Hepatocellular Carcinoma Huge
Lead Sponsor:
Fan Weijun
Conditions:
Hepatocellular Carcinoma Non-resectable
Transarterial Chemoembolization
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study was to prospectively evaluate the efficacy and safety of TACE combined with MWA in patients with huge unresectable hepatocellular carcinoma.
Detailed Description
Hepatocellular carcinoma (HCC) is the fifth most common cancer worldwide. Despite the widespread application of surveillance programs in high-risk populations, patients continue to present with huge (...
Eligibility Criteria
Inclusion
- The performance status of Eastern Cooperative Oncology Group (ECOG) must be 0-1
- The diagnosis of primary hepatocellular carcinoma must be in line with the American Society for the study of liver diseases (AASLD) diagnostic criteria for hepatocellular carcinoma (HCC)
- Child-Pugh score A or B;
- Aged from 18 to 75 years;
- Subjects voluntarily join the study, and signe informed consent;
- No anti-tumor therapy was received；
- Meet the following 4 characteristics: A. primary tumor diameter more than or equal to 10cm; B. no more than 3 HCC foci, and the maximum diameter is less than or equal to 5cm; C. with IIa, I or no portal vein tumor thrombus (Cheng's Classification)；D. the tumor could not be surgically removed
- No extrahepatic metastases
Exclusion
- Abnormal coagulation function: PLT \< 40×109/L, PTA \< 40%;
- Patients have the past history of liver cancer treatment, such as transplantation, resection, radiotherapy, chemotherapy and so on;
- Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
- Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;
- Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
- Patients accompanied with other tumors or past medical history of malignancy;
- Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment;
- Allergic to adriamycin chemotherapy drugs，contrast agent and lipiodol;
- Patients have poor compliance.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03277716
Start Date
December 1 2017
End Date
December 30 2021
Last Update
May 7 2019
Active Locations (10)
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1
Cancer Institute &Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
2
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
3
The tumor hospital of Fujian Province
Fuzhou, Fujian, China, 350014
4
the First Affiliated Hospital of SunYat-senUniversity
Guangzhou, Guangdong, China, 510080