Actively Recruiting
Tadalafil Effect + Chemotherapy in Resectable Gastric/GEJ Cancer
Led by University of Arizona · Updated on 2025-10-16
10
Participants Needed
1
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tadalafil Effect + Chemotherapy in Resectable Gastric/GEJ Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Stage I-III (T1-3Nx) gastric or gastroesophageal junction adenocarcinoma confirmed by histology or cytology
- Radiographically measurable disease by RECIST 1.1 with MRI or CT scan within 28 days prior to treatment
- Age 18 years or older
- Adequate organ and marrow function based on specified laboratory tests within 14 days before treatment
- ECOG performance status of 0 or 1
- Agreement to use medically accepted contraception during study and for 6 months after treatment if sexually active and fertile
- Female subjects of childbearing potential must not be pregnant at screening
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Prior treatment for gastric cancer
- Prior treatment with Tadalafil or other PDE inhibitors within 28 days
- Known metastatic disease
- Uncontrolled or significant recent illnesses including serious cardiovascular disorders
- Gastrointestinal disorders with high risk of perforation or fistula
- Active or history of autoimmune disease or immune deficiency with specified exceptions
- Active infection requiring systemic treatment except specified infections
- Recent SARS-COV-2 infection without full recovery
- Known HIV or tuberculosis infection
- Use of nitrates, alpha-blockers, CYP3A4 inhibitors or inducers
- Serious non-healing wounds, uncompensated hypothyroidism, or moderate to severe liver impairment
- Major surgery within 2 weeks before first dose without complete wound healing
- Recent treatment with systemic immunosuppressive medication with specified exceptions
- Pregnancy, breastfeeding, or intention to become pregnant during or within 6 months after study
- Inability to swallow tablets
- Allergy or hypersensitivity to study treatment components
- Previous non-arteritic anterior ischemic optic neuropathy
- Other active malignancy requiring treatment within 3 years except certain localized cancers
AI-Screening
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Trial Site Locations
Total: 1 location
1
Arizona Cancer Center at UMC North/University Medical Center
Tucson, Arizona, United States, 85719
Actively Recruiting
Research Team
P
Prisca Zimmerman
CONTACT
R
Rachel E Jarrett
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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