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Taking people in CanadaPhase 2

Tests new drug combinations before and after surgery for stomach and esophageal cancer

Tests new drugs given before and after surgery in adults with stomach or esophageal cancer.

Key facts

Who runs it
AstraZeneca
Where
Montreal and Toronto, CanadaSee the 2 sitesAlso in 10 other countries, 57 sites
Registry title
A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma
Status
Recruiting
Phase
Phase 2
People taking part
100 people, planned
Started
17 Jul 2025
Expected to end
16 Jul 2029
Type of study
Interventional, 5 groups
Treatments tested
  • Sonesitatug Vedotin
  • Rilvegostomig
  • Trastuzumab Deruxtecan (T-DXd)
  • Capecitabine
  • 5-Fluorouracil (5-FU)
  • FLOT Chemotherapy
  • Calcium folinate
Record updated
3 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with stomach, gastroesophageal junction or esophagus cancer (adenocarcinoma) that can be removed by surgery and has not been treated before.

Age
18 years or older
Sex
All sexes can join
Disease stage
Adenocarcinoma of the stomach, gastroesophageal junction or esophagus that can be removed by surgery (resectable). No known or suspected distant spread.
Earlier treatment
Cannot have had any earlier cancer treatment or surgery for this cancer.
Biomarker or test result
CLDN18.2-positive for Sub-study 1; HER2-positive for Sub-study 2; no specific requirement for Sub-study 3.

Main reasons for not taking part

  • Any earlier cancer treatment or surgery for this cancer
  • Autoimmune or inflammatory disease treated with steroids or other immune-suppressing drugs
  • Past or current interstitial lung disease or pneumonitis
  • Known or suspected distant spread of the cancer
  • History of another primary cancer

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

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 immunosuppressive treatment
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of study intervention
  • 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
  • Uncontrolled hepatitis B and/or chronic or active hepatitis B
  • Central nervous system (CNS) pathology
  • Participants with any known or suspicious distant metastasis

Where in Canada

Also in 10 other countries, 57 sites

  • Montreal, QuebecHospital not named in the registryTaking people
  • Toronto, OntarioHospital not named in the registryNo longer taking part

About the trial

What the trial wants to find out

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.

The 5 groups in the trial

  • Sub-study 1: Cohort 1a - Sonesitatug Vedotin plus Rilvegostomig and 5-FU or CapecitabineTreatment being tested

    Participants will receive Sonesitatug Vedotin (Dose A) plus Rilvegostomig and 5-FU or Capecitabine as neoadjuvant combination therapy (pre-surgery period) and adjuvant therapy 1 and later will receive Sonesitatug vedotin (Dose A) plus Rilvegostomig as adjuvant therapy 2.

    Treatment: Sonesitatug Vedotin, Rilvegostomig, Capecitabine, and 5-Fluorouracil (5-FU)

  • Sub-study 2: T-DXd plus Rilvegostomig and 5-FU or CapecitabineTreatment being tested

    Participants will receive T-DXd plus Rilvegostomig and 5-FU or Capecitabine as neoadjuvant combination therapy (pre-surgery period) and adjuvant therapy 1 and later will receive Rilvegostomig as adjuvant therapy 2.

    Treatment: Rilvegostomig, Trastuzumab Deruxtecan (T-DXd), Capecitabine, and 5-Fluorouracil (5-FU)

  • Sub-study 3: Rilvegostomig plus FLOT chemotherapyTreatment being tested

    Participants will receive Rilvegostomig plus FLOT chemotherapy as neoadjuvant combination therapy (pre-surgery period) and adjuvant therapy 1 and later will receive Rilvegostomig as adjuvant therapy 2.

    Treatment: Rilvegostomig and FLOT Chemotherapy

  • Sub-study 1: Cohort 1b - Sonesitatug Vedotin plus Rilvegostomig and CapecitabineTreatment being tested

    Participants will receive Sonesitatug vedotin (Dose B) plus Rilvegostomig and Capecitabine as neoadjuvant combination therapy (pre-surgery period) and adjuvant therapy 1 and later will receive Sonesitatug vedotin (Dose B) plus Rilvegostomig as adjuvant therapy 2.

    Treatment: Sonesitatug Vedotin, Rilvegostomig, and Capecitabine

  • Sub-study 1: Cohort 1c - Sonesitatug Vedotin plus Rilvegostomig plus 5-FU and calcium folinateTreatment being tested

    Participants will receive Sonesitatug Vedotin (Dose C) plus Rilvegostomig plus 5-FU and calcium folinate as neoadjuvant combination therapy (pre-surgery period) and adjuvant therapy 1 and later will receive Sonesitatug vedotin (Dose C) plus Rilvegostomig as adjuvant therapy 2.

    Treatment: Sonesitatug Vedotin, Rilvegostomig, 5-Fluorouracil (5-FU), and Calcium folinate

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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)
Plain-language title
Tests new drug combinations before and after surgery for stomach and esophageal cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
3 November 2026