A PILOT STUDY TO IDENTIFY MOLECULAR PREDICTORS OF SENSITIVITY AND RESISTANCE TO TRANS-ARTERIAL EMBOLIZATION OF PRIMARY LIVER TUMORS AND LIVER METASTASES
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Liver Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Locations
- 1
- Primary Endpoint
- response
- Status
- Withdrawn
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to see if certain genes the tumor can help predict how the tumor will respond to Trans-Arterial Embolization (TAE). A gene is the basic physical and functional unit of heredity. Genes are made up of DNA; DNA (deoxyribonucleic acid) is the hereditary material in humans. Identifying a gene that can predict how liver tumors will respond to TAE will also help to determine if adjuvant therapy will be needed after TAE.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histopathologic evidence of primary liver cancer or liver metastases
- •Indication of TAE for the treatment of liver tumor
- •Age ≥ 18 years
- •Available tissue with adequate tissue for analysis, verified by a pathologist
Exclusion Criteria
- •History of a second active malignancy with evidence of metastatic disease
Outcomes
Primary Outcomes
response
Time Frame: within 4 weeks
Response will be categorized using standard mRECIST criteria. Tumor response will be catalogued as follows: Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions. Stable Disease (SD): Any cases that do not qualify for either partial response or progressive disease. Progressive Disease (PD): An increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the of viable (enhancing) target lesions recorded since treatment started.