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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Sonesitatug Vedotin (drug), Rilvegostomig (drug), Trastuzumab Deruxtecan (T-DXd) (drug), Capecitabine (drug)
How long the study runs: Study runs about 48 months (dates as stated)
About the drug or intervention: Sonesitatug Vedotin — drug: Sonesitatug Vedotin will be administered as an IV infusion. · Rilvegostomig — drug: Rilvegostomig will be administered as an IV infusion. · Trastuzumab Deruxtecan (T-DXd) — drug: T-DXd will be administered as an IV infusion. · Capecitabine — drug: Capecitabine (Fluoropyrimidine) will be administered orally as chemotherapy standard of care. · 5-Fluorouracil (5-FU) — drug: 5-FU (Fluoropyrimidine) will be administered as a continuous IV infusion as chemotherapy standard of care. · FLOT Chemotherapy — drug: FLOT (5-FU, leucovorin, oxaliplatin, and docetaxel) Chemotherapy will be administered as an IV infusion. · Calcium folinate — drug: Calcium folinate will be administered as an IV infusion as chemotherapy standard of care.
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 18 Years and over
Who: All
Number of participants: 100
Started: 2025-07-17
Last checked: 2026-11

Plain English Summary

What is this study?

• Testing a new treatment for gastroesophageal adenocarcinoma
• Phase2 - 100 participants
• 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

Who can take part?

• Ages 18 Years and over
• Diagnosed with gastroesophageal adenocarcinoma

Where?

• Bristol - Research Site
• Dundee - Research Site
• Headington - Research Site
• London - Research Site
• +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

This Phase II, open-label, multi-drug, multi-center platform study consists of individual sub-studies/cohorts, each allows the assessment of multiple novel agents or novel combinations. Participants will be assigned across different sub-studies/cohorts, to have sufficient evaluable participants of the confirmed recommended dose by Safety Review Committee (SRC) for study intervention in each corresponding sub-study/cohort.

Gastroesophageal Adenocarcinoma

How this trial compares with your answers

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What we know so far

Condition· Matched your search

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Still need:

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• Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years and over
Who can join: All genders

Biomarkers mentioned

HER2

What the study is looking for

✓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...
✓activity scale (ECOG) performance status of 0 or 1
✓Adequate organ and bone marrow function
✓Body weight \> 35 kg

Who cannot take part

✗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...
✗Central nervous system (CNS) pathology
✗Uncontrolled infections
✗Participants with history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, current ILD/pneumonitis,...

See the full 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

Where Is This Study? (5 UK sites)

Research Site

Bristol BS2 8ED, United Kingdom

WITHDRAWN

Research Site

Dundee DD1 9SY, United Kingdom

Recruiting

Research Site

Headington OX3 7LJ, United Kingdom

Recruiting

Research Site

London E1 1BB, United Kingdom

WITHDRAWN

Research Site

Norwich NR4 7UY, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com

Data sourced from ClinicalTrials.gov · Last verified: 2026-11