Last updated: April 25, 2022
Sponsor: Tata Memorial Hospital
Overall Status: Active - Recruiting
Phase
2/3
Condition
Digestive System Neoplasms
Primary Biliary Cholangitis
Liver Cancer
Treatment
N/AClinical Study ID
NCT02794337
TMC IEC III 91
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosis of HCC. Tissue diagnosis is not mandatory however desirable. In the absenceof tissue diagnosis imaging findings characteristic of HCC will be used. i.e. in highrisk population a nodule with arterial phase enhancement and wash out duringportovenous phase will be considered as diagnostic of HCC. In patients where oneimaging is not conclusive another imaging modality will be used. However if secondimaging is also inconclusive and Alpha Feto Protein (AFP) is within the nondiagnosticor borderline range than tissue diagnosis will be deemed mandatory.
- Barcelona Stage B/ Barcelona A not deemed suitable for Sx or refuse surgery. ChildPugh A/Select Child Pugh B (score7/10).
- Eastern Cooperative Oncology Group Performance Status 0-1.
- Total number of measurable target lesions 2 or less than 2, can be encompassed withina single hepatic field or 2 different hepatic fields without exceeding safe dose limitconstraints.
- Optimal predicted liver volume reserve >700 cc. No Contraindication for TACE. Tumorconsidered to be sufficiently away from GI structures to deliver safe radiation dose (>1 cm).
- Willing for molecular banking of tumour tissue (optional).
Exclusion
Exclusion Criteria:
- Metastatic or nodal disease on staging investigations.
- Child C Cirrhosis or previous history of liver failure. Expected life span <6 months.
- Active variceal bleeding or other signs of hepatic decompensation.
- Portal venous thrombosis rendering patients unsuitable for TACE. However if pt issuitable for superselective TACE then can be considered for trial inclusion.
Study Design
Total Participants: 67
Study Start date:
December 01, 2014
Estimated Completion Date:
January 31, 2024
Study Description
Connect with a study center
Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre
Navi Mumbai, Maharashtra 410210
IndiaActive - Recruiting
Advanced Centre of Treatment Research and Education In Cancer,Tata Memorial Centre
Navi Mumbai, Maharashtra 410210
IndiaActive - Recruiting

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