Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastroesophageal Adenocarcinoma | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil (5-FU) | Drug | Fluorouracil | ALIAS |
| Calcium folinate | Drug | Immunomodulatory Oligonucleotide | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| FLOT Chemotherapy | Drug | — | UNRESOLVED |
| Rilvegostomig | Drug | — | UNRESOLVED |
| Sonesitatug Vedotin | Drug | — | UNRESOLVED |
| Trastuzumab Deruxtecan (T-DXd) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Sub-study 1: Cohort 1a - Sonesitatug Vedotin plus Rilvegostomig and 5-FU or Capecitabine
- description
- 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.
- interventionNames
- Drug: Sonesitatug Vedotin
- Drug: Rilvegostomig
- Drug: Capecitabine
- Drug: 5-Fluorouracil (5-FU)
- type
- EXPERIMENTAL
- label
- Sub-study 2: T-DXd plus Rilvegostomig and 5-FU or Capecitabine
- description
- 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.
- interventionNames
- Drug: Rilvegostomig
- Drug: Trastuzumab Deruxtecan (T-DXd)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available