Tadalafil Effect + Chemotherapy in Resectable Gastric/GEJ Cancer

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT05709574
Phase
PHASE2
Status
Recruiting
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Conditions

  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tadalafil 20 MG — DRUG
    Tadalafil 20 mg tablets will be taken daily for 2 weeks alone and then for 8 weeks in combination with neoadjuvant chemotherapy in the window between gastric/GEJ adenocarcinoma diagnosis and interventional surgery.

Study Details

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.

Key Dates

Start date
Apr 20, 2023
Status verified
Oct 2025
Primary completion
Mar 30, 2026
Completion
May 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tadalafil + chemotherapy
    Subjects will receive Tadalafil monotherapy for 2 weeks followed by Tadalafil in combination with neoadjuvant FLOT chemotherapy for 8 weeks in the window between their cancer diagnosis and surgical intervention.

Primary Outcome Measure

Evaluating the safety and tolerability of tadalafil treatment with FLOT chemotherapy by assessing the number of participants with treatment related adverse events usting CTCAE v. 5.0. [ Time Frame: 10 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Arizona Cancer Center at UMC North/University Medical CenterTucsonArizona85719
Junaid Arshad, MD
[email protected]
520-694-2873
Prisca Zimmerman
[email protected]
520-626-8286
Junaid Arshad, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Arizona Cancer Center at UMC North/University Medical Center· Tucson, AZ

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