Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC (TIGeR-PaC)

  • STATUS
    Recruiting
  • End date
    Sep 10, 2023
  • participants needed
    320
  • sponsor
    RenovoRx
Updated on 10 March 2022

Summary

The study is a multi-center, un-blinded, randomized control study of subjects with locally advanced pancreatic adenocarcinoma which is unresectable.

Description

All subjects will receive induction therapy of IV gemcitabine plus nab-paclitaxel, as well as radiation therapy for approximately four months. Subjects who remain eligible will then be randomized to receive either intra-arterial chemotherapy with gemcitabine; or to continue gemcitabine plus nab-paclitaxel. Subjects will receive the randomized treatments for up to 16 weeks or until progression. Both groups will receive either IV gemcitabine and nab-paclitaxel or oral capecitabine following the 16 week treatment course until disease progression at the discretion of the Investigator.

Details
Condition Locally Advanced Pancreatic Cancer
Treatment Gemcitabine, Nab-paclitaxel, RenovoCath
Clinical Study IdentifierNCT03257033
SponsorRenovoRx
Last Modified on10 March 2022

Eligibility

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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