A Randomized, Double-blind, Placebo-controlled, Phase III Study of Neoadjuvant-Adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Patients With Resectable Gastric and Gastroesophageal Junction Cancer (GC/GEJC)
- Conditions
- Gastrointestinal Neoplasms, Esophagogastric Junction
- Registration Number
- JPRN-jRCT2031210307
- Lead Sponsor
- Hibi Kazushige
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 86
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method