Single-arm, Window Trial of Tadalafil Effect + Chemotherapy in Resectable Gastric/GEJ Cancer
Status:
Not yet recruiting
Trial end date:
2025-05-01
Target enrollment:
Participant gender:
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.