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Tadalafil Effect + Chemotherapy in Resectable Gastric/GEJ Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruitingv7 Show 4 more changesShow less
    • Enrollment target: estimated 10 to confirmed 11
    • Primary completion date changed from estimate of Mar 30, 2026 to Jun 3, 2026
    • Study completion date: May 31, 2026 to Oct 30, 2026
    • Site details revised
  2. Primary completion date: Sep 2025 to Mar 30, 2026
    • Study completion date: Sep 2025 to May 31, 2026
    v6
  3. Primary completion date: Mar 2025 to Sep 2025
    • Study completion date: May 2025 to Sep 2025
    v5
  4. Primary completion date: Mar 2024 to Mar 2025
    • Start date: Mar 3, 2023 to Apr 20, 2023
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2023 to Mar 3, 2023
    • Site details revised
    v3
  6. Primary endpoint revised
    • Secondary endpoints revised (2)
    • Study title shortened, about 4 words
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to assess the ability of Tadalafil alone and in combination with neoadjuvant FLOT (5-Fluorouracil, Oxaliplatin, and Docetaxel) chemotherapy to suppress myeloid derived suppressor cells (MDSCs) in patients with resectable gastric or gastroesophageal junction adenocarcinoma. Resectable means the tumor may be removed through surgical intervention. Neoadjuvant chemotherapy is chemotherapy received before the primary course of treatment i.e.surgical intervention. The main questions it aims to answer are: * Is Tadalafil treatment with FLOT feasible and safe? * How does tadalafil treatment with FLOT affect the tumor microenvironment (TME)? * Will 8 weeks of neoadjuvant exposure to tadalafil with chemotherapy reduce MDSCs in the TME? Participants will receive Tadalafil for 14 days followed by combination of Tadalafil + FLOT for approximately 8 weeks as a part of standard of care neoadjuvant treatment in the window between cancer diagnosis and surgical intervention to remove their tumor. Tumor tissue, blood, and urine will be collected at the start of the study, after 2 weeks of treatment with Tadalafil alone, and around the time of surgical intervention. Saliva will also be collected at the start of the study.
Trial Details
NCT Number NCT05709574
Lead Sponsor University of Arizona
Conditions
(from sponsor)		 Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Enrollment 11 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov