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

NCT07069712 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-18

No results posted yet for this study

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.

Conditions

  • Gastroesophageal Adenocarcinoma

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.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY
  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-17
Primary Completion
2027-01-28
Completion
2028-09-06
FDA Drug
Yes

Countries

  • United States
  • Canada
  • China
  • Georgia
  • Italy
  • Japan
  • Poland
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07069712 on ClinicalTrials.gov