Back to resultsMicrowave Ablation Combined With TACE in the Treatment of Unresectable Huge Hepatocellular Carcinoma Huge
Primary Purpose
Hepatocellular Carcinoma Non-resectable, Transarterial Chemoembolization, Microwave Ablation
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TACE
MWA
MWA system
Chemoembolization
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma Non-resectable focused on measuring Huge hepatocellular carcinoma, Microwave ablation, TACE, Safety, Non-resectable, Treatment
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Cancer Institute &Hospital, Chinese Academy of Medical Sciences
- The First Affiliated Hospital of Fujian Medical UniversityRecruiting
- The tumor hospital of Fujian Province
- the First Affiliated Hospital of SunYat-senUniversity
- Shenzhen People's HospitalRecruiting
- Peking University Hospital of ShenzhenRecruiting
- The Second Affiliated Hospital of Shandong UniversityRecruiting
- Shandong Province HospitalRecruiting
- the Affiliated Hospital of Medical College Qingdao UniversityRecruiting
- The First Affiliated Hospital of Zhejiang University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TACE+MWA
Arm Description
Transcatheter arterial chemoembolization combined with microwave ablation: 2-3 times of TACE treatment, then followed by ablation treatment using MWA system.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Progression-free survival (PFS)
Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per mRECIST) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment.
Adverse event rate
Adverse event rate will be defined as the rate of patients who developed adverse event.
Distant metastasis-free survival
Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented distant metastasis (as per RECIST 1.1) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment .
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03277716
Brief Title
Microwave Ablation Combined With TACE in the Treatment of Unresectable Huge Hepatocellular Carcinoma Huge
Official Title
Effectivity and Safety of Microwave Ablation Combined With Transcatheter Arterial Chemoembolization(TACE) for Huge Unresectable Hepatocellular Carcinoma: a Multicenter Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fan Weijun
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 (≥ 10 cm) HCCs.And it's still a challenge to treat huge HCC nowadays.Surgical resection is currently the only curative treatment for huge HCCs ; however, only a minority of patients are candidates for curative resection. Sorafenib is recommended for the treatment of advanced HCCs, including huge HCCs, but the usage is severely limited by high adverse event rates and low efficiency. Thus, transarterial chemoembolization (TACE) is considered the first choice for huge unresectable HCCs. Several studies have concluded that TACE effectively improves the overall survival of patients with huge HCCs. Meanwhile, microwave ablation (MWA) now has been shown to be safe and effective for local tumor control in HCC patients. However, neither MWA nor TACE alone can achieve complete control of large HCCs . Therefore, the combination of TACE and MWA (TACE+MWA) is an appealing approach to treat HCCs. TACE+MWA now has been shown to improve overall survival rates compared with TACE alone in patients with small to large HCCs. But little data is available on TACE+MWA in patients with huge unresectable HCCs. Thus, the study was designed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma Non-resectable, Transarterial Chemoembolization, Microwave Ablation
Keywords
Huge hepatocellular carcinoma, Microwave ablation, TACE, Safety, Non-resectable, Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Microwave Ablation Combined With TACE in the Treatment of Non-resectable Huge Hepatocellular Carcinoma
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TACE+MWA
Arm Type
Experimental
Arm Description
Transcatheter arterial chemoembolization combined with microwave ablation: 2-3 times of TACE treatment, then followed by ablation treatment using MWA system.
Intervention Type
Procedure
Intervention Name(s)
TACE
Other Intervention Name(s)
Transcatheter arterial chemoembolization procedure
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
MWA
Other Intervention Name(s)
Microwave ablation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
MWA system
Other Intervention Name(s)
Microwave ablation system
Intervention Description
MWA system is a kind of medical treatment instrument to restrain and kill tumor based on microwave heating technique and biology heating effect theory.
Intervention Type
Drug
Intervention Name(s)
Chemoembolization
Other Intervention Name(s)
Chemotherapeutic drugs and Embolic agent
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall survival (OS)
Description
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.
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per mRECIST) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment.
Time Frame
up to 3 years
Title
Adverse event rate
Description
Adverse event rate will be defined as the rate of patients who developed adverse event.
Time Frame
up to 3 years
Title
Distant metastasis-free survival
Description
Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented distant metastasis (as per RECIST 1.1) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment .
Time Frame
up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weijun Fan, M.D.
Phone
+86-020-87343272
Email
fanweijun1964@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Han Qi, M.D.
Phone
+86-020-87343272
Email
qihan@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weijun Fan, M.D
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Institute &Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao Li, M.D
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenyu Lin, M.D.
Facility Name
The tumor hospital of Fujian Province
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hailan Lin, M.D
Facility Name
the First Affiliated Hospital of SunYat-senUniversity
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiaping Li, M.D
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanfang Zhang, M.D.
Facility Name
Peking University Hospital of Shenzhen
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518036
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junhui Chen, M.D.
Facility Name
The Second Affiliated Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuliang Li, M.D
Facility Name
Shandong Province Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Ye, M.D
Facility Name
the Affiliated Hospital of Medical College Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
26555
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zixiang Li, M.D
Facility Name
The First Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junhui Sun, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
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Microwave Ablation Combined With TACE in the Treatment of Unresectable Huge Hepatocellular Carcinoma Huge
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