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RECRUITING
NCT07069712
PHASE2

A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-07-17

Completion Date

2028-09-06

Last Updated

2026-03-10

Healthy Volunteers

No

Interventions

DRUG

AZD0901

AZD0901 will be administered as an IV infusion.

DRUG

Rilvegostomig

Rilvegostomig will be administered as an IV infusion.

DRUG

Trastuzumab Deruxtecan (T-DXd)

T-DXd will be administered as an IV infusion.

DRUG

Capecitabine

Capecitabine (Fluoropyrimidine) will be administered orally as chemotherapy standard of care.

DRUG

5-Fluorouracil (5-FU)

5-FU (Fluoropyrimidine) will be administered as an IV infusion as chemotherapy standard of care.

DRUG

FLOT Chemotherapy

FLOT (5-FU, leucovorin, oxaliplatin, and docetaxel) Chemotherapy will be administered as an IV infusion.

Locations (70)

Research Site

Newark, Delaware, United States

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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

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New York, New York, United States

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Pittsburgh, Pennsylvania, United States

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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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

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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

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Tbilisi, Georgia

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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

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Pisa, Italy

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Rozzano, Italy

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Udine, Italy

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Vicenza, Italy

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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

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Suita-shi, Japan

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Yokohama, Japan

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Bialystok, Poland

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Warsaw, Poland

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Barcelona, Spain

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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

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Taoyuan District, Taiwan

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Adapazarı, Turkey (Türkiye)

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Erzurum, Turkey (Türkiye)

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Fatih-Istanbul, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Bristol, United Kingdom

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Dundee, United Kingdom

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Headington, United Kingdom

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London, United Kingdom

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Norwich, United Kingdom