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Tadalafil with Chemotherapy for Gastric/GEJ Cancer

This study is looking at how Tadalafil, a medication, works alone and with standard chemotherapy (FLOT) for people with resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma. Resectable means the tumor can be removed with surgery. The goal is to see if Tadalafil can help reduce certain cells called myeloid derived suppressor cells (MDSCs) that can make cancer treatments less effective. You could be eligible if you are 18 or older and have Stage I-III gastric or GEJ adenocarcinoma that can be measured on scans. The main goal is to check the safety of Tadalafil with FLOT chemotherapy over 10 weeks by tracking any side effects.

Study design
This is an interventional study with a planned enrollment of 11 participants. The phase of the study is not specified.
What's involved
You would take Tadalafil daily for 2 weeks alone, and then for 8 weeks with chemotherapy before surgery. Imaging scans are required within 28 days before starting treatment.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for safety and tolerability is measured at 10 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05709574

Tadalafil Effect + Chemotherapy in Resectable Gastric/GEJ Cancer

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Arizona
~11 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Tadalafil 20 MG

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over 10 weeks

Conditions

Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma

Explore related trials

Gastric AdenocarcinomaGastroesophageal Junction Adenocarcinoma

NCT05709574

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Arizona Cancer Center at UMC North/University Medical Center

    Tucson, Arizonano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Junaid Arshad, MD · PRINCIPAL_INVESTIGATOR · University of Arizona

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Males: (140 - age) x weight (kg)/(serum creatinine \[mg/dL\] × 72)
Females: \[(140 - age) x weight (kg)/(serum creatinine \[mg/dL\] × 72)\] × 0.85 5. ECOG performance status ≤ 1. 6. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 6 months after the last dose of study treatment. 7. Female subjects of childbearing potential must not be pregnant at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria are met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \> 45 years-of-age in the absence of other biological or physiological causes. Note: Documentation may include review of medical records, medical examinations, or medical history interview by study site. 8. Ability to understand and the willingness to sign a written informed consent.

What this trial measures

  • 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. 5.0.10 weeks

    To evaluate the safety and tolerability by assessing the number of participants with treatment related adverse events using CTCAE v5.0.