Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Ca… (NCT04592913) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer
United States957 participantsStarted 2020-11-17
Plain-language summary
This is a Global Study of Neoadjuvant-Adjuvant Durvalumab or Placebo and FLOT Chemotherapy Followed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN).
Who can participate
Age range18 Years – 200 Years
SexALL
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Key Inclusion Criteria:
* 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.
Key Exclusion Criteria:
* 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.