TATE

Recruiting
99 years and younger
All
Phase N/A
15 participants needed
1 Location

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
  • Age: - 99 Years
  • Gender: All

TBD

Updated on 01 Aug 2024. Study ID: 854569

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