Gastroesophageal Adenocarcinoma
Conditions
Interventions
Sub-study 1: AZD0901 plus rilvegostomig and 5-FU or capecitabine
Participants will receive AZD0901 plus rilvegostomig and 5-FU orcapecitabine as neoadjuvantcombination therapy (pre-surgeryperiod) and
Sponsors
Hibi Kazushige
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically documented gastric, GEJ, or esophagealadenocarcinoma with resectable disease - Participants who are CLDN18.2-positive and HER2-negative in Sub-study 1 or HER2-positive in Sub-study 2; no specific requirements forSub-study 3 - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Adequate organ and bone marrow function - Body weight > 35 kg
Exclusion criteria
Exclusion criteria: - Participants had any prior anti-cancer treatment or surgery for thecurrent gastric, GEJ, or esophageal cancer. - Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment - Central nervous system (CNS) pathology - Uncontrolled infections - Participants with history of (non-infectious) interstitial lung disease(ILD)/pneumonitis, current ILD/pneumonitis, or suspectedILD/pneumonitis - History of another primary malignancy - Participants with any known or suspicious distant metastasis - Uncontrolled hepatitis B and/or chronic or active hepatitis B - Current or prior use of immunosuppressive medication within 14 days before the first dose of study intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverseevents (AEs) and serious adverse events (SAEs) Percentage of participants with pathological complete response(pCR) | — |
Countries
Canada, China, Gergia, Italy, Japan, Poland, Spain, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactKazushige Hibi
Astrazeneka K.K
Outcome results
None listed