Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer
- Patients with histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease (Stage II or higher per AJCC 8th edition).
- Patients must undergo radical surgery.
- No prior anti-cancer therapy for the current malignancy.
- World Health Organization (WHO)/ECOG performance status of 0 or 1 at enrollment.
- Adequate organ and marrow function.
- Availability of tumor sample prior to study entry.
- Must have a life expectancy of at least 24 weeks.
- Patients with peritoneal dissemination or distant metastasis.
- Patients with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
- Contra-indication to any of the study drugs.
- History of allogeneic organ transplantation.
This study investigates treatment of durvalumab or placebo therapy combined with FLOT
chemotherapy (flurouroacil + leucovorin + oxaliplatin + docetaxel) given before surgery
(neoadjuvant) and durvalumab or placebo therapy combined with FLOT chemotherapy after surgery
(adjuvant), will work and be safe for the treatment of resectable (removable by surgery)
gastric or gastroesophageal cancer, and also to better understand the studied disease and
associated health problems.
Trial Phase Phase III
Trial Type Treatment
AstraZeneca Pharmaceuticals LP
- Primary ID D910GC00001
- Secondary IDs NCI-2021-01109, 2019-001555-40
- Clinicaltrials.gov ID NCT04592913