TACE Combined With Synchronous Radiofrequency /Microwave Ablation to Treat Large and Huge Hepatocellular Carcinoma
NCT ID: NCT02630108
Last Updated: 2016-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
280 participants
INTERVENTIONAL
2015-12-31
2018-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Thermal Ablation & TACE
Transarterial chemoembolization (TACE) is performed immediately following thermal ablation.
EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
Thermal Ablation
Thermal ablation in this trial includes radiofrequency ablation and microwave ablation, one of them can be chosen to be performed.
EADM
EADM is a chemotherapy drug used in transarterial chemoembolization (TACE).Dosage: EADM 30-60 mg per patient,depending on the situation of the patient.
Ultra-fluid lipiodol
Ultra-fluid lipiodol is a kind of embolization material used in TACE. Standard: 38% ultra-fluid lipiodol .
Gelatin sponge articles
Gelatin sponge articles embolization material used in TACE. Standard: 350-560 um in diameter.
TACE alone
Only TACE is performed. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
EADM
EADM is a chemotherapy drug used in transarterial chemoembolization (TACE).Dosage: EADM 30-60 mg per patient,depending on the situation of the patient.
Ultra-fluid lipiodol
Ultra-fluid lipiodol is a kind of embolization material used in TACE. Standard: 38% ultra-fluid lipiodol .
Gelatin sponge articles
Gelatin sponge articles embolization material used in TACE. Standard: 350-560 um in diameter.
Interventions
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Thermal Ablation
Thermal ablation in this trial includes radiofrequency ablation and microwave ablation, one of them can be chosen to be performed.
EADM
EADM is a chemotherapy drug used in transarterial chemoembolization (TACE).Dosage: EADM 30-60 mg per patient,depending on the situation of the patient.
Ultra-fluid lipiodol
Ultra-fluid lipiodol is a kind of embolization material used in TACE. Standard: 38% ultra-fluid lipiodol .
Gelatin sponge articles
Gelatin sponge articles embolization material used in TACE. Standard: 350-560 um in diameter.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with large HCC (\>5cm in diameter) and huge HCC (≥10cm in diameter), including HCC and mixed type of liver cancer (HCC-ICC);
3. Patients with no thrombus in main portal vein (PV)
4. Patients' liver function classified as Child-Pugh A or B, ECOG PS ≤ 2;
5. Patients without bleeding tendency or coagulation disorder, or with reversible coagulopathy after therapy;
6. White blood cell count ≥ 3.0×10\^9/L;
7. Hemoglobin ≥ 8.5g/dl;
8. Platelet ≥ 50×10\^9/L;
9. INR ≤ 2.3 or PT not exceeding the upper limit of reference 3 seconds;
10. Blood creatinine less than 1.5 times of upper limit of reference;
11. Patients and/or their relatives willing to join in the clinical trial and signing the informed consent.
Exclusion Criteria
2. Cholangiocellular carcinoma
3. Patients with main PV thrombus;
4. Patients with hepatic vein thrombus;
5. Patients with lymph node or distant metastasis outside of liver;
6. Patients' liver function classified as Child-Pugh C and no improvement after treatment of liver protection;
7. Patients with irreversible coagulation disorder and abnormality in blood routine test, or having obvious bleeding tendency;
8. Patients with intractable massive ascites;
9. Patients' ECOG PS \>2;
10. Patients complicated with active infection, especially cholangitis;
11. Patients with severe disorders of heart, lungs, kidneys, or brain;
12. Patients and/or their relatives refuse to anticipate this study.
18 Years
80 Years
ALL
No
Sponsors
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Xijing Hospital
OTHER
Changhai Hospital
OTHER
Eastern Hepatobiliary Surgery Hospital
OTHER
Shanghai Cancer Hospital, China
OTHER
Shengjing Hospital
OTHER
The Third Affiliated Hospital of Harbin Medical University
OTHER
Jilin Provincial Tumor Hospital
OTHER
Zhejiang Cancer Hospital
OTHER
Jiangsu Cancer Institute & Hospital
OTHER
Guangdong Provincial People's Hospital
OTHER
Sichuan Cancer Hospital and Research Institute
OTHER
Henan Cancer Hospital
OTHER_GOV
Anhui Provincial Hospital
OTHER_GOV
The First Affiliated Hospital of Anhui Medical University
OTHER
Qilu Hospital of Shandong University
OTHER
Shandong Tumor Hospital
OTHER
First Affiliated Hospital of Xinjiang Medical University
OTHER
Chinese PLA General Hospital
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
LanZhou University
OTHER
Sun Yat-sen University
OTHER
Hunan Provincial People's Hospital
OTHER
Affiliated Zhongshan Hospital of Dalian University
OTHER
Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Principal Investigators
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Jianhua Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Locations
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Department of Interventional Radiology, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Related Links
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Link Text: wiley
Link Text:BioMed Central
Link Text:Elsevier Science
Link Text:PubMed Central
Link Text:PubMed Central
Link Text:ProQuest Health and Medical Complete New Platform
Link Text:Georg Thieme Verlag Stuttgart, New York
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Link Text:Springer
Link Text:HighWire
Link Text:Wiley
Other Identifiers
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B2015-146R
Identifier Type: -
Identifier Source: org_study_id
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