It is a prospective and multi-center clinical research in China to compare the efficacy,
safety and related impact factors between TACE alone and TACE combined with synchronous
multi-point MWA/RFA for large and huge liver cancer.
Procedure: Thermal Ablation
Drug: Ultra-fluid lipiodol
Other: Gelatin sponge articles
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Locations near you
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Full eligibility criteria for NCT02630108
Ages eligible for Study
18 Years to 80 Years
Genders eligible for Study
Accepts Healthy Volunteers
Patients with primary liver cancer aged from 18-80 years, and life expectancy longer than three months;
Patients with large HCC (>5cm in diameter) and huge HCC (≥10cm in diameter), including HCC and mixed type of liver cancer (HCC-ICC);
Patients with no thrombus in main portal vein (PV)
Patients' liver function classified as Child-Pugh A or B, ECOG PS ≤ 2;
Patients without bleeding tendency or coagulation disorder, or with reversible coagulopathy after therapy;
White blood cell count ≥ 3.0×10^9/L;
Hemoglobin ≥ 8.5g/dl;
Platelet ≥ 50×10^9/L;
INR ≤ 2.3 or PT not exceeding the upper limit of reference 3 seconds;
Blood creatinine less than 1.5 times of upper limit of reference;
Patients and/or their relatives willing to join in the clinical trial and signing the informed consent.
Patients with diffuse type of liver cancer;
Patients with main PV thrombus;
Patients with hepatic vein thrombus;
Patients with lymph node or distant metastasis outside of liver;
Patients' liver function classified as Child-Pugh C and no improvement after treatment of liver protection;
Patients with irreversible coagulation disorder and abnormality in blood routine test, or having obvious bleeding tendency;
Patients with intractable massive ascites;
Patients' ECOG PS >2;
Patients complicated with active infection, especially cholangitis;
Patients with severe disorders of heart, lungs, kidneys, or brain;
Patients and/or their relatives refuse to anticipate this study.
All locations for NCT02630108
Department of Interventional Radiology, Zhongshan Hospital, Fudan University
Shanghai, Shanghai, China, 200032
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View full eligibility
Tris trial is registered with FDA with number: NCT02630108. The sponsor of the trial is Shanghai Zhongshan Hospital and it is looking for 280 volunteers for the current phase.
Official trial title: Clinical Study of Transarterial Chemoembolization (TACE) Combined With Synchronous Radiofrequency /Microwave Ablation to Treat Large and Huge Hepatocellular Carcinoma
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