Status:
UNKNOWN
The Efficacy of Transarterial Chemoinfusion (TAI) Combine Stereotactic Body Radiation Therapy (SBRT) in Unresectable Hepatocellular Carcinoma (HCC)
Lead Sponsor:
Sun Yat-sen University
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To evaluate the efiicacy of TAI combine SBRT in unresectable HCC
Eligibility Criteria
Inclusion
- older than 18 years old and younger than 75 years;
- ECOG PS≤1;
- proven advanced hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
- not previous treated for tumor;
- cannot accepted hepatectomy;
- the lab test could meet:
- neutrophil count≥2.0×109/L;
- hemoglobin≥100g/L;
- platelet count≥75×109/L;
- serum albumin≥35g/L;
- total bilirubin\<2-times upper limit of normal;
- ALT\<3-times upper limit of normal;
- AST\<3-times upper limit of normal;
- serum creatine\<1.5-times upper limit of normal;
- PT≤upper limit of normal plus 4 seconds;
- INR≤2.2;
- sign up consent.
Exclusion
- cannot tolerate TAI or SBRT;
- known history of other malignancy;
- be allergic to related drugs;
- underwent organ transplantation before;
- be treated before (interferon included);
- known history of HIV infection;
- known history of drug or alcohol abuse;
- have GI hemorrhage or cardiac/brain vascular events within 30 days;
- pregnancy.
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2022
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03851887
Start Date
December 1 2018
End Date
January 31 2022
Last Update
February 22 2019
Active Locations (1)
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1
SUN YAT-SEN University Cancer Center
Guangzhou, Guangdong, China, 510060