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Trial Title:
M-TACE Treatment for Unresectable Hepatocellular Carcinoma
NCT ID:
NCT05875558
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
M-TACE
Description:
Lipiodol combined with microspheres
Arm group label:
M-TACE
Summary:
This study aims to investigate the safety and efficacy of transarterial
chenmoembolization（TACE） combined with microspheres for unresectable hepatocellular
carcinoma(HCC).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 18≤Age<80 on day of signing informed consent.
2. Have histologically confirmed diagnosis or radiological diagnosis of HCC with at
least one >3cm targeted lesion.
3. Have Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease,
BCLC stage A disease but refuse a surgical or ablation therapy.
4. Have a Child-Pugh Class A/B（<7） liver score.
5. Have a performance status of 0 or 1 using the ECOG.
6. Have a predicted life expectancy of greater than 3 months.
Exclusion Criteria:
1. The targeted lesions have received TACE or other locoregional therapy within 3
months.
2. Tumor burden over 70% of the liver volume.
3. Lesions can not be measured by mRECIST.
4. Has a diagnosed additional malignancy.
5. Patients with Hb<9.0g/dL, WBC<1.0×10^9/L， TB>3mg/dL，ALT/AST>5 UL, ALB<2.8g/dL，
INR>2.3, Cr >2mg/mL or CCr<30mL/min.
6. Severe heart, lung or cerebral disease.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Interventional Radiology, Zhongshan Hospital, Fudan University.
Address:
City:
Shanghai
Zip:
200032
Country:
China
Start date:
July 1, 2022
Completion date:
July 1, 2024
Lead sponsor:
Agency:
Shanghai Zhongshan Hospital
Agency class:
Other
Source:
Shanghai Zhongshan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05875558
