Microwave Ablation Combined With TACE in the Treatment of Unresectable Huge Hepatocellular Carcinoma Huge
NCT ID: NCT03277716
Last Updated: 2019-05-07
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
100 participants
INTERVENTIONAL
2017-12-01
2021-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
TACE Combined With Synchronous Radiofrequency /Microwave Ablation to Treat Large and Huge Hepatocellular Carcinoma
NCT02630108
TACE Combined With RFA/MV Treatment in Hepatocellular Carcinoma Beyond Milan Criterial
NCT03636620
PVE/PVL Combined With DEB-TACE in the Treatment of Patients With Large and Unresectable Liver Cancer
NCT05103007
Combined Therapy for Hepatocellular Carcinoma >3-<5 cm
NCT04721470
Efficacy of Sequential TACE and PVE on the Resectability of Hepatitis B Related HCC
NCT00834158
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TACE+MWA
Transcatheter arterial chemoembolization combined with microwave ablation: 2-3 times of TACE treatment, then followed by ablation treatment using MWA system.
TACE
TACE: With the patient under local anesthesia, a 5F French catheter was introduced into the abdominal aorta via the femoral artery using the Seldinger technique. Hepatic arterial angiography was performed using fluoroscopy to guide the catheter into the celiac and superior mesenteric arteries. Then, the feeding arteries, tumor, and vascular anatomy surrounding the tumor were identified. Subsequently, a microcatheter was super-selectively inserted into the feeding arteries. Then, a mixture solution containing chemotherapeutic agents and embolic agents were infused into the artery according to the size and blood supply of the tumors.
MWA
MWA: All patients were instructed to fast from all foods for 12 hours preoperatively. During the procedure, a CT scan was used to locate the liver tumors, and to design the optimal puncture needle route. Routine disinfection and local anesthesia was applied around the puncture point, and a 16-gauge microwave antenna was gradually inserted into the tumor along the pre-determined angle. Settings of the MWA parameters depended on the manufacturer's recommendation and our experience.
MWA system
MWA system is a kind of medical treatment instrument to restrain and kill tumor based on microwave heating technique and biology heating effect theory.
Chemoembolization
Chemotherapeutic drugs: adriamycin，epirubicin and pirarubicin. Embolic agent: lipiodol and embolic microspherea The mixture solution containing chemotherapeutic drugs and embolic agent were infused into the artery according to by the number and size of the lesions, liver and kidney function of the patient, and blood supply of the tumors.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TACE
TACE: With the patient under local anesthesia, a 5F French catheter was introduced into the abdominal aorta via the femoral artery using the Seldinger technique. Hepatic arterial angiography was performed using fluoroscopy to guide the catheter into the celiac and superior mesenteric arteries. Then, the feeding arteries, tumor, and vascular anatomy surrounding the tumor were identified. Subsequently, a microcatheter was super-selectively inserted into the feeding arteries. Then, a mixture solution containing chemotherapeutic agents and embolic agents were infused into the artery according to the size and blood supply of the tumors.
MWA
MWA: All patients were instructed to fast from all foods for 12 hours preoperatively. During the procedure, a CT scan was used to locate the liver tumors, and to design the optimal puncture needle route. Routine disinfection and local anesthesia was applied around the puncture point, and a 16-gauge microwave antenna was gradually inserted into the tumor along the pre-determined angle. Settings of the MWA parameters depended on the manufacturer's recommendation and our experience.
MWA system
MWA system is a kind of medical treatment instrument to restrain and kill tumor based on microwave heating technique and biology heating effect theory.
Chemoembolization
Chemotherapeutic drugs: adriamycin，epirubicin and pirarubicin. Embolic agent: lipiodol and embolic microspherea The mixture solution containing chemotherapeutic drugs and embolic agent were infused into the artery according to by the number and size of the lesions, liver and kidney function of the patient, and blood supply of the tumors.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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)
3. Child-Pugh score A or B;
4. Aged from 18 to 75 years;
5. Subjects voluntarily join the study, and signe informed consent;
6. No anti-tumor therapy was received；
7. 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
8. No extrahepatic metastases
Exclusion Criteria
2. Patients have the past history of liver cancer treatment, such as transplantation, resection, radiotherapy, chemotherapy and so on;
3. Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
4. Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;
5. Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
6. Patients accompanied with other tumors or past medical history of malignancy;
7. Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment;
8. Allergic to adriamycin chemotherapy drugs，contrast agent and lipiodol;
9. Patients have poor compliance.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fan Weijun
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Fan Weijun
the professor of Sun Yat-sen University
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Weijun Fan, M.D
Role: STUDY_CHAIR
Sun Yat-sen University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cancer Institute &Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The tumor hospital of Fujian Province
Fuzhou, Fujian, China
the First Affiliated Hospital of SunYat-senUniversity
Guangzhou, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Peking University Hospital of Shenzhen
Shenzhen, Guangdong, China
The Second Affiliated Hospital of Shandong University
Jinan, Shandong, China
Shandong Province Hospital
Jinan, Shandong, China
the Affiliated Hospital of Medical College Qingdao University
Qingdao, Shandong, China
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Xiao Li, M.D
Role: primary
Zhenyu Lin, M.D.
Role: primary
Hailan Lin, M.D
Role: primary
Jiaping Li, M.D
Role: primary
Yanfang Zhang, M.D.
Role: primary
Junhui Chen, M.D.
Role: primary
Yuliang Li, M.D
Role: primary
Xin Ye, M.D
Role: primary
Zixiang Li, M.D
Role: primary
Junhui Sun, M.D.
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Maida M, Orlando E, Camma C, Cabibbo G. Staging systems of hepatocellular carcinoma: a review of literature. World J Gastroenterol. 2014 Apr 21;20(15):4141-50. doi: 10.3748/wjg.v20.i15.4141.
Bruix J, Sherman M; American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma: an update. Hepatology. 2011 Mar;53(3):1020-2. doi: 10.1002/hep.24199. No abstract available.
Yamashita Y, Taketomi A, Shirabe K, Aishima S, Tsuijita E, Morita K, Kayashima H, Maehara Y. Outcomes of hepatic resection for huge hepatocellular carcinoma (>/= 10 cm in diameter). J Surg Oncol. 2011 Sep 1;104(3):292-8. doi: 10.1002/jso.21931. Epub 2011 Apr 4.
Brunocilla PR, Brunello F, Carucci P, Gaia S, Rolle E, Cantamessa A, Castiglione A, Ciccone G, Rizzetto M. Sorafenib in hepatocellular carcinoma: prospective study on adverse events, quality of life, and related feasibility under daily conditions. Med Oncol. 2013 Mar;30(1):345. doi: 10.1007/s12032-012-0345-2. Epub 2012 Dec 22.
Abdelaziz AO, Nabeel MM, Elbaz TM, Shousha HI, Hassan EM, Mahmoud SH, Rashed NA, Ibrahim MM, Abdelmaksoud AH. Microwave ablation versus transarterial chemoembolization in large hepatocellular carcinoma: prospective analysis. Scand J Gastroenterol. 2015 Apr;50(4):479-84. doi: 10.3109/00365521.2014.1003397. Epub 2015 Jan 16.
Xue T, Le F, Chen R, Xie X, Zhang L, Ge N, Chen Y, Wang Y, Zhang B, Ye S, Ren Z. Transarterial chemoembolization for huge hepatocellular carcinoma with diameter over ten centimeters: a large cohort study. Med Oncol. 2015 Mar;32(3):64. doi: 10.1007/s12032-015-0504-3. Epub 2015 Feb 15.
Min YW, Lee JH, Gwak GY, Paik YH, Lee JH, Rhee PL, Koh KC, Paik SW, Yoo BC, Choi MS. Long-term survival after surgical resection for huge hepatocellular carcinoma: comparison with transarterial chemoembolization after propensity score matching. J Gastroenterol Hepatol. 2014 May;29(5):1043-8. doi: 10.1111/jgh.12504.
Chen MS, Li JQ, Zheng Y, Guo RP, Liang HH, Zhang YQ, Lin XJ, Lau WY. A prospective randomized trial comparing percutaneous local ablative therapy and partial hepatectomy for small hepatocellular carcinoma. Ann Surg. 2006 Mar;243(3):321-8. doi: 10.1097/01.sla.0000201480.65519.b8.
Feng K, Yan J, Li X, Xia F, Ma K, Wang S, Bie P, Dong J. A randomized controlled trial of radiofrequency ablation and surgical resection in the treatment of small hepatocellular carcinoma. J Hepatol. 2012 Oct;57(4):794-802. doi: 10.1016/j.jhep.2012.05.007. Epub 2012 May 23.
Lu MD, Kuang M, Liang LJ, Xie XY, Peng BG, Liu GJ, Li DM, Lai JM, Li SQ. [Surgical resection versus percutaneous thermal ablation for early-stage hepatocellular carcinoma: a randomized clinical trial]. Zhonghua Yi Xue Za Zhi. 2006 Mar 28;86(12):801-5. Chinese.
Huang YH, Wu JC, Chen SC, Chen CH, Chiang JH, Huo TI, Lee PC, Chang FY, Lee SD. Survival benefit of transcatheter arterial chemoembolization in patients with hepatocellular carcinoma larger than 10 cm in diameter. Aliment Pharmacol Ther. 2006 Jan 1;23(1):129-35. doi: 10.1111/j.1365-2036.2006.02704.x.
Kim JH, Won HJ, Shin YM, Kim SH, Yoon HK, Sung KB, Kim PN. Medium-sized (3.1-5.0 cm) hepatocellular carcinoma: transarterial chemoembolization plus radiofrequency ablation versus radiofrequency ablation alone. Ann Surg Oncol. 2011 Jun;18(6):1624-9. doi: 10.1245/s10434-011-1673-8. Epub 2011 Mar 29.
Mizukoshi E, Yamashita T, Arai K, Sunagozaka H, Ueda T, Arihara F, Kagaya T, Yamashita T, Fushimi K, Kaneko S. Enhancement of tumor-associated antigen-specific T cell responses by radiofrequency ablation of hepatocellular carcinoma. Hepatology. 2013 Apr;57(4):1448-57. doi: 10.1002/hep.26153.
Zerbini A, Pilli M, Penna A, Pelosi G, Schianchi C, Molinari A, Schivazappa S, Zibera C, Fagnoni FF, Ferrari C, Missale G. Radiofrequency thermal ablation of hepatocellular carcinoma liver nodules can activate and enhance tumor-specific T-cell responses. Cancer Res. 2006 Jan 15;66(2):1139-46. doi: 10.1158/0008-5472.CAN-05-2244.
Kim YS, Lim HK, Rhim H, Lee MW, Choi D, Lee WJ, Paik SW, Koh KC, Lee JH, Choi MS, Gwak GY, Yoo BC. Ten-year outcomes of percutaneous radiofrequency ablation as first-line therapy of early hepatocellular carcinoma: analysis of prognostic factors. J Hepatol. 2013 Jan;58(1):89-97. doi: 10.1016/j.jhep.2012.09.020. Epub 2012 Sep 27.
Shiina S, Tateishi R, Arano T, Uchino K, Enooku K, Nakagawa H, Asaoka Y, Sato T, Masuzaki R, Kondo Y, Goto T, Yoshida H, Omata M, Koike K. Radiofrequency ablation for hepatocellular carcinoma: 10-year outcome and prognostic factors. Am J Gastroenterol. 2012 Apr;107(4):569-77; quiz 578. doi: 10.1038/ajg.2011.425. Epub 2011 Dec 13.
Peng ZW, Zhang YJ, Chen MS, Xu L, Liang HH, Lin XJ, Guo RP, Zhang YQ, Lau WY. Radiofrequency ablation with or without transcatheter arterial chemoembolization in the treatment of hepatocellular carcinoma: a prospective randomized trial. J Clin Oncol. 2013 Feb 1;31(4):426-32. doi: 10.1200/JCO.2012.42.9936. Epub 2012 Dec 26.
Kim JW, Shin SS, Kim JK, Choi SK, Heo SH, Lim HS, Hur YH, Cho CK, Jeong YY, Kang HK. Radiofrequency ablation combined with transcatheter arterial chemoembolization for the treatment of single hepatocellular carcinoma of 2 to 5 cm in diameter: comparison with surgical resection. Korean J Radiol. 2013 Jul-Aug;14(4):626-35. doi: 10.3348/kjr.2013.14.4.626. Epub 2013 Jul 17.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
sysucc01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.