TATE
Brief description of study
Primary:
To determine the preliminary efficacy of TATE in the locoregional treatment of NET liver metastases using ORR based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 and the DoR.
Secondary:
Determine the toxicity of TATE in NET patients with liver-dominant metastases
Determine the PFS by mRECIST and RECIST 1.1 and OS at 12 and 24 months after first TATE treatment This is an expansion cohort of a phase I study to explore the preliminary efficacy of TATE in
NET liver metastases. It is a single arm, open-label study and all enrolled patients will receive
TATE treatment. The primary endpoint is ORR by RECIST 1.1 criteria per standard approach
and DoR. Secondary endpoints include ORR and DoR by mRECIST 1.1 criteria, RR for tumor target
lesions that are treated with TATE, PFS and OS at 12 and 24 months, toxicity of tirapazamine when combined with TAE. Response will be plotted in a waterfall plot, and RR will be
calculated by mRECIST and RECIST 1.1 criteria.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
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Age: - 99 Years
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Gender: All
TBD
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