NCT07069712From ClinicalTrials.govRecruiting

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)

Gastroesophageal Adenocarcinoma

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: AstraZeneca
Enrolment target: 100
Started: 17 July 2025
Main results due: 9 November 2027
Study sites: 70
Registry updated: 24 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

* Histologically documented gastric, GEJ, or esophageal adenocarcinoma with resectable disease
* Participants who are CLDN18.2-positive 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

Exclusion Criteria:

* 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(70)

Research Site
Newark, Delaware, United States
Recruiting
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Washington D.C., District of Columbia, United States
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Fairway, Kansas, United States
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North Shores, Michigan, United States
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New York, New York, United States
Withdrawn
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New York, New York, United States
Recruiting
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Pittsburgh, Pennsylvania, United States
Not yet recruiting
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Toronto, Ontario, Canada
Withdrawn
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Montreal, Quebec, Canada
Recruiting
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Montreal, Quebec, Canada
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Beijing, China
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Changchun, China
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Changzhi, China
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Chengdu, China
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Chengdu, China
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Fuzhou, China
Not yet recruiting
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Hangzhou, China
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Hangzhou, China
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Kunming, China
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Qingdao, China
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Shanghai, China
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Shijiazhuang, China
Withdrawn
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Tbilisi, Georgia
Recruiting
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Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Florence, Italy
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Milan, Italy
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Milan, Italy
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Milan, Italy
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Modena, Italy
Withdrawn
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Pisa, Italy
Recruiting
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Rozzano, Italy
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Udine, Italy
Not yet recruiting
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Vicenza, Italy
Recruiting
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Chūōku, Japan
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Fukuoka, Japan
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Hidaka-shi, Japan
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Kashiwa, Japan
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Kitaadachi-gun, Japan
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Kōtoku, Japan
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Nagoya, Japan
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Osaka, Japan
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Osaka, Japan
Withdrawn
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Suita-shi, Japan
Recruiting
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Yokohama, Japan
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Bialystok, Poland
Withdrawn
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Warsaw, Poland
Withdrawn
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Barcelona, Spain
Recruiting
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Barcelona, Spain
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Elche, Spain
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Madrid, Spain
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Málaga, Spain
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Ourense, Spain
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Oviedo, Spain
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Santander, Spain
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Valencia, Spain
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Kaohsiung City, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
Recruiting

Showing 60 of 70 sites — filter to narrow it down. 54 of the 70 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07069712. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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