A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma
A Master Protocol of an Open-Label, Multi-Drug, Multi-Center, Phase II Platform Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (GEMINI-PeriOp GC)
2 other identifiers
interventional
100
11 countries
70
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2025
Typical duration for phase_2
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2025
CompletedFirst Posted
Study publicly available on registry
July 17, 2025
CompletedStudy Start
First participant enrolled
July 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 6, 2028
April 23, 2026
April 1, 2026
1.5 years
June 24, 2025
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
To assess the safety and tolerability of perioperative treatment.
Until sub-study completion, up to 38 months
Percentage of participants with pathological complete response (pCR)
pCR is defined as no viable cancer cells, including lymph nodes after complete evaluation in the resected gastric, GEJ, or esophageal cancer specimen and all sampled regional lymph nodes following neoadjuvant treatment.
Until sub-study completion, up to 38 months
Secondary Outcomes (9)
Surgery completion rate as planned
Until sub-study completion, up to 38 months
R0 resection (complete resection) rate as planned
Until sub-study completion, up to 38 months
Percentage of participants with tumor downstaging
Until sub-study completion, up to 38 months
Event-free survival (EFS)
Until sub-study completion, up to 38 months
Disease-free survival (DFS)
Until sub-study completion, up to 38 months
- +4 more secondary outcomes
Study Arms (3)
Sub-study 1: AZD0901 plus Rilvegostomig and 5-FU or Capecitabine
EXPERIMENTALParticipants will receive AZD0901 plus Rilvegostomig and 5-FU or Capecitabine as neoadjuvant combination therapy (pre-surgery period) and adjuvant combination therapy (post-surgery period) and later will receive Rilvegostomig as adjuvant monotherapy.
Sub-study 2: T-DXd plus Rilvegostomig and 5-FU or Capecitabine
EXPERIMENTALParticipants will receive T-DXd plus Rilvegostomig and 5-FU or Capecitabine as neoadjuvant combination therapy (pre-surgery period) and adjuvant combination therapy (post-surgery period) and later will receive Rilvegostomig as adjuvant monotherapy.
Sub-study 3: Rilvegostomig plus FLOT chemotherapy
EXPERIMENTALParticipants will receive Rilvegostomig plus FLOT chemotherapy as neoadjuvant combination therapy (pre-surgery period) and adjuvant combination therapy (post-surgery period) and later will receive Rilvegostomig as adjuvant monotherapy.
Interventions
AZD0901 will be administered as an IV infusion.
Rilvegostomig will be administered as an IV infusion.
T-DXd will be administered as an IV infusion.
Capecitabine (Fluoropyrimidine) will be administered orally as chemotherapy standard of care.
5-FU (Fluoropyrimidine) will be administered as an IV infusion as chemotherapy standard of care.
FLOT (5-FU, leucovorin, oxaliplatin, and docetaxel) Chemotherapy will be administered as an IV infusion.
Eligibility Criteria
You may qualify if:
- Histologically documented gastric, GEJ, or esophageal adenocarcinoma 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 for Sub-study 3
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and bone marrow function
- Body weight \> 35 kg
You may not qualify if:
- Participants had any prior anti-cancer treatment or surgery for the current 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 suspected ILD/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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Parexelcollaborator
Study Sites (70)
Research Site
Newark, Delaware, 19713, United States
Research Site
Washington D.C., District of Columbia, 20007, United States
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Fairway, Kansas, 66205, United States
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North Shores, Michigan, 49444, United States
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New York, New York, 10032, United States
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New York, New York, 10065, United States
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Pittsburgh, Pennsylvania, 15232, United States
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H2X 3E4, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Beijing, 100142, China
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Changchun, 130021, China
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Changzhi, 046000, China
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Chengdu, 610041, China
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Chengdu, 610042, China
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Fuzhou, 350014, China
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Hangzhou, 310003, China
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Hangzhou, 310014, China
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Kunming, 650118, China
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Qingdao, 266003, China
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Shanghai, 200025, China
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Shijiazhuang, 050020, China
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Tbilisi, 0112, Georgia
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Tbilisi, 0114, Georgia
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Tbilisi, 0144, Georgia
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Tbilisi, 0159, Georgia
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Florence, 50134, Italy
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Milan, 20133, Italy
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Milan, 20141, Italy
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Milan, 20162, Italy
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Modena, 41124, Italy
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Pisa, 56100, Italy
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Rozzano, 20089, Italy
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Udine, 33100, Italy
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Vicenza, 36100, Italy
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Chūōku, 104-0045, Japan
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Fukuoka, 812-8582, Japan
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Hidaka-shi, 350-1298, Japan
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Kashiwa, 277-8577, Japan
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Kitaadachi-gun, 362-0806, Japan
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Kōtoku, 135-8550, Japan
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Nagoya, 464-8681, Japan
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Osaka, 541-8567, Japan
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Osaka, 558-8558, Japan
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Suita-shi, 565-0871, Japan
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Yokohama, 241-8515, Japan
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Bialystok, 15-027, Poland
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Warsaw, 02-034, Poland
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Elche, 03203, Spain
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Madrid, 28007, Spain
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Málaga, 29010, Spain
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Ourense, 32005, Spain
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Oviedo, 33011, Spain
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Santander, 39008, Spain
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Valencia, 46010, Spain
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Kaohsiung City, 80756, Taiwan
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Tainan, 704, Taiwan
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Taipei, 11217, Taiwan
Research Site
Taoyuan District, 33305, Taiwan
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Adapazarı, 54100, Turkey (Türkiye)
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Erzurum, 25240, Turkey (Türkiye)
Research Site
Fatih-Istanbul, 34098, Turkey (Türkiye)
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Istanbul, 34722, Turkey (Türkiye)
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Bristol, BS2 8ED, United Kingdom
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Dundee, DD1 9SY, United Kingdom
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Headington, OX3 7LJ, United Kingdom
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London, E1 1BB, United Kingdom
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Norwich, NR4 7UY, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2025
First Posted
July 17, 2025
Study Start
July 17, 2025
Primary Completion (Estimated)
January 28, 2027
Study Completion (Estimated)
September 6, 2028
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.