Microwave Ablation Combined With TACE in the Treatment of Unresectable Huge Hepatocellular Carcinoma Huge

NCT03277716 | Unknown DMC

• 1 other identifier: sysucc01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 10

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.

Conditions

Hepatocellular Carcinoma Non-resectable; Transarterial Chemoembolization; Microwave Ablation

Keywords

Huge hepatocellular carcinoma; Microwave ablation; TACE; Safety; Non-resectable; Treatment

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  Overall survival (OS) will be defined as the elapsed time from the enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive). Follow-up for OS will occur every 12 weeks (±1 month) until death or withdrawal of consent from the study.

  up to 3 years

Secondary Outcomes (3)

• Progression-free survival (PFS)

  up to 3 years

• Adverse event rate

  up to 3 years

• Distant metastasis-free survival

  up to 3 years

Study Arms (1)

TACE+MWA

EXPERIMENTAL

Transcatheter arterial chemoembolization combined with microwave ablation: 2-3 times of TACE treatment, then followed by ablation treatment using MWA system.

Procedure: TACE; Procedure: MWA; Device: MWA system; Drug: Chemoembolization

Interventions

TACE PROCEDURE

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.

Also known as: Transcatheter arterial chemoembolization procedure

TACE+MWA

MWA PROCEDURE

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.

Also known as: Microwave ablation

TACE+MWA

MWA system DEVICE

MWA system is a kind of medical treatment instrument to restrain and kill tumor based on microwave heating technique and biology heating effect theory.

Also known as: Microwave ablation system

TACE+MWA

Chemoembolization DRUG

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.

Also known as: Chemotherapeutic drugs and Embolic agent

TACE+MWA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fan Weijun: lead

Study Sites (10)

Cancer Institute &Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

NOT YET RECRUITING

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

The tumor hospital of Fujian Province

Fuzhou, Fujian, 350014, China

NOT YET RECRUITING

the First Affiliated Hospital of SunYat-senUniversity

Guangzhou, Guangdong, 510080, China

NOT YET RECRUITING

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

RECRUITING

Peking University Hospital of Shenzhen

Shenzhen, Guangdong, 518036, China

RECRUITING

The Second Affiliated Hospital of Shandong University

Jinan, Shandong, 250000, China

RECRUITING

Shandong Province Hospital

Jinan, Shandong, 250014, China

RECRUITING

the Affiliated Hospital of Medical College Qingdao University

Qingdao, Shandong, 26555, China

RECRUITING

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

NOT YET RECRUITING

Related Publications (18)

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 22634125 BACKGROUND

• 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.

  PMID: 16681964 BACKGROUND

• 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.

  PMID: 16393290 BACKGROUND

• 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.

  PMID: 21445671 BACKGROUND

• 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.

  PMID: 23174905 BACKGROUND

• 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.

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• 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.

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• 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.

  PMID: 23901320 BACKGROUND

MeSH Terms

Interventions

Chemoembolization, Therapeutic

Intervention Hierarchy (Ancestors)

Embolization, Therapeutic; Hemostatic Techniques; Therapeutics; Therapeutic Occlusion

Study Officials

• Weijun Fan, M.D

  Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Weijun Fan, M.D.

CONTACT

+86-020-87343272; fanweijun1964@126.com

Han Qi, M.D.

CONTACT

+86-020-87343272; qihan@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: the professor of Sun Yat-sen University

Model Details: Microwave Ablation Combined With TACE in the Treatment of Non-resectable Huge Hepatocellular Carcinoma

Study Record Dates

• First Submitted: August 6, 2017
• First Posted: September 11, 2017
• Study Start: December 1, 2017
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2021
• Last Updated: May 7, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)