A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma
Start Date
7/17/2025
Completion Date
9/6/2028
Summary
GEMINI-PeriOp GC study will assess the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of novel agents or novel combinations as perioperative treatment in participants with locally advanced resectable gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma who have not received previous treatment for the disease.
Detailed Description
This Phase II, open-label, multi-drug, multi-center platform study consists of individual sub-studies, each allows the assessment of multiple novel agents or novel combinations. Participants will be assigned across 3 sub-studies, to have sufficient evaluable participants of the confirmed recommended dose by Safety Review Committee (SRC) for study intervention in each corresponding sub-study.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
AZD0901
Rilvegostomig
Trastuzumab Deruxtecan (T-DXd)
Capecitabine
5-Fluorouracil (5-FU)
FLOT Chemotherapy
Conditions
Locations
Research Site
Newark, Delaware 19713
United States
Research Site
Washington D.C., District of Columbia 20007
United States
Research Site
Fairway, Kansas 66205
United States
Research Site
North Shores, Michigan 49444
United States
Research Site
New York, New York 10032
United States
Research Site
New York, New York 10065
United States
Research Site
Pittsburgh, Pennsylvania 15232
United States
Research Site
Toronto, Ontario M5G 2M9
Canada
Research Site
Montreal, Quebec H2X 3E4
Canada
Research Site
Montreal, Quebec H4A 3J1
Canada
Research Site
Beijing, 100142
China
Research Site
Changchun, 130021
China
Research Site
Changzhi, 046000
China
Research Site
Chengdu, 610041
China
Research Site
Chengdu, 610042
China
Research Site
Fuzhou, 350014
China
Research Site
Hangzhou, 310003
China
Research Site
Hangzhou, 310014
China
Research Site
Kunming, 650118
China
Research Site
Qingdao, 266003
China
Research Site
Shanghai, 200025
China
Research Site
Shijiazhuang, 050020
China
Research Site
Tbilisi, 0112
Georgia
Research Site
Tbilisi, 0114
Georgia
Research Site
Tbilisi, 0144
Georgia
Research Site
Tbilisi, 0159
Georgia
Research Site
Florence, 50134
Italy
Research Site
Milan, 20133
Italy
Research Site
Milan, 20141
Italy
Research Site
Milan, 20162
Italy
Research Site
Modena, 41124
Italy
Research Site
Pisa, 56100
Italy
Research Site
Rozzano, 20089
Italy
Research Site
Udine, 33100
Italy
Research Site
Vicenza, 36100
Italy
Research Site
Chūōku, 104-0045
Japan
Research Site
Fukuoka, 812-8582
Japan
Research Site
Hidaka-shi, 350-1298
Japan
Research Site
Kashiwa, 277-8577
Japan
Research Site
Kitaadachi-gun, 362-0806
Japan
Research Site
Kōtoku, 135-8550
Japan
Research Site
Nagoya, 464-8681
Japan
Research Site
Osaka, 541-8567
Japan
Research Site
Osaka, 558-8558
Japan
Research Site
Suita-shi, 565-0871
Japan
Research Site
Yokohama, 241-8515
Japan
Research Site
Bialystok, 15-027
Poland
Research Site
Warsaw, 02-034
Poland
Research Site
Barcelona, 08035
Spain
Research Site
Barcelona, 08036
Spain
Research Site
Elche, 03203
Spain
Research Site
Madrid, 28007
Spain
Research Site
Málaga, 29010
Spain
Research Site
Ourense, 32005
Spain
Research Site
Oviedo, 33011
Spain
Research Site
Santander, 39008
Spain
Research Site
Valencia, 46010
Spain
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Kaohsiung City, 80756
Taiwan
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Tainan, 704
Taiwan
Research Site
Taipei, 11217
Taiwan
Research Site
Taoyuan, 33305
Taiwan
Research Site
Adapazarı, 54100
Turkey (Türkiye)
Research Site
Erzurum, 25240
Turkey (Türkiye)
Research Site
Fatih-Istanbul, 34098
Turkey (Türkiye)
Research Site
Istanbul, 34722
Turkey (Türkiye)
Research Site
Bristol, BS2 8ED
United Kingdom
Research Site
Dundee, DD1 9SY
United Kingdom
Research Site
Headington, OX3 7LJ
United Kingdom
Research Site
London, E1 1BB
United Kingdom
Research Site
Norwich, NR4 7UY
United Kingdom