RecruitingPhase 2NCT05709574

Tadalafil Effect + Chemotherapy in Resectable Gastric/GEJ Cancer

An Open-Label, Phase II Single-Arm, Window Trial of Tadalafil Effect + Chemotherapy in Patients With Resectable Gastric/GEJ Adenocarcinoma


Sponsor

University of Arizona

Enrollment

10 participants

Start Date

Apr 20, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding tadalafil (a drug commonly used for erectile dysfunction and blood pressure) to standard chemotherapy can improve outcomes in patients with stomach or stomach-esophagus junction cancer that is eligible for surgery. **You may be eligible if...** - You have been diagnosed with stage I–III stomach or gastroesophageal junction cancer, confirmed by biopsy - Your cancer is measurable on imaging - You are 18 or older - Your blood counts, liver, and kidney function are within acceptable ranges - You are in generally good health (ECOG performance status 0–1) **You may NOT be eligible if...** - You have a serious heart condition, recent heart attack, or uncontrolled blood pressure - You are taking certain medications that interact with tadalafil (e.g., nitrates) - You have recently used blood thinners beyond a certain threshold - You are pregnant or breastfeeding - You have poor kidney or liver function beyond study thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTadalafil 20 MG

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.


Locations(1)

Arizona Cancer Center at UMC North/University Medical Center

Tucson, Arizona, United States

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NCT05709574


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