Tadalafil Effect + Chemotherapy in Resectable Gastric/GEJ Cancer (NCT05709574)
An Open-Label, Phase II Single-Arm, Window Trial of Tadalafil Effect + Chemotherapy in Patients With Resectable Gastric/GEJ Adenocarcinoma
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Arizona Cancer Center at UMC North/University Medical Center — Tucson, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Arizona Cancer Center at UMC North/University Medical Center — Tucson, Arizona
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Gastric Adenocarcinoma
- Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors — Scottsdale, Arizona
- Neoadjuvant Intra-tumoral RP2 and FLOT in Gastroesophageal Adenocarcinoma — Philadelphia, Pennsylvania
- Magnetic Sentinel Lymph Node Mapping in Gastric Cancer — Houston, Texas
- GI-05: The Impact of Olanzapine Among Patients Receiving Neoadjuvant Chemotherapy for Gastric Cancer — Chicago, Illinois
- A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology — Houston, Texas
Explore by condition: All Gastric Adenocarcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.