M-TACE Treatment for Unresectable Hepatocellular Carcinoma
Not Applicable
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Procedure: M-TACE
- Registration Number
- NCT05875558
- Lead Sponsor
- Shanghai Zhongshan Hospital
- Brief Summary
This study aims to investigate the safety and efficacy of transarterial chenmoembolization（TACE） combined with microspheres for unresectable hepatocellular carcinoma(HCC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- 18≤Age<80 on day of signing informed consent.
- Have histologically confirmed diagnosis or radiological diagnosis of HCC with at least one >3cm targeted lesion.
- 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.
- Have a Child-Pugh Class A/B（<7） liver score.
- Have a performance status of 0 or 1 using the ECOG.
- Have a predicted life expectancy of greater than 3 months.
Exclusion Criteria
- The targeted lesions have received TACE or other locoregional therapy within 3 months.
- Tumor burden over 70% of the liver volume.
- Lesions can not be measured by mRECIST.
- Has a diagnosed additional malignancy.
- 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.
- Severe heart, lung or cerebral disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description M-TACE M-TACE -
- Primary Outcome Measures
Name Time Method ORR 3 months after first mTACE Objective response rate according to the mRECIST
- Secondary Outcome Measures
Name Time Method OS 3 years Overall survival
Trial Locations
- Locations (1)
Department of Interventional Radiology, Zhongshan Hospital, Fudan University.
🇨🇳Shanghai, Shanghai, China