Hepatocellular Carcinoma
Conditions
Brief summary
This study aims to investigate the safety and efficacy of transarterial chenmoembolization（TACE） combined with microspheres for unresectable hepatocellular carcinoma(HCC).
Interventions
PROCEDUREM-TACE
Lipiodol combined with microspheres
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 1 month after first mTACE | Objective response rate according to the mRECIST |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 1 year | Overall survival |
Countries
China
Outcome results
None listed