RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2025-07-17
Study Completion:2028-09-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07069712

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically documented gastric, GEJ, or esophageal adenocarcinoma with resectable disease
  2. * Participants who are CLDN18.2-positive and HER2-negative in Sub-study 1 or HER2-positive in Sub-study 2; no specific requirements for Sub-study 3
  3. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  4. * Adequate organ and bone marrow function
  5. * Body weight \> 35 kg
  1. * Participants had any prior anti-cancer treatment or surgery for the current gastric, GEJ, or esophageal cancer.
  2. * Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment
  3. * Central nervous system (CNS) pathology
  4. * Uncontrolled infections
  5. * Participants with history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, current ILD/pneumonitis, or suspected ILD/pneumonitis
  6. * History of another primary malignancy
  7. * Participants with any known or suspicious distant metastasis
  8. * Uncontrolled hepatitis B and/or chronic or active hepatitis B
  9. * Current or prior use of immunosuppressive medication within 14 days before the first dose of study intervention

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Newark, Delaware, 19713
United States
Research Site
Washington, District of Columbia, 20007
United States
Research Site
Fairway, Kansas, 66205
United States
Research Site
N. Shores, Michigan, 49444
United States
Research Site
New York, New York, 10032
United States
Research Site
New York, New York, 10065
United States
Research Site
Pittsburgh, Pennsylvania, 15232
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-17
Study Completion Date2028-09-20

Study Record Updates

Study Start Date2025-07-17
Study Completion Date2028-09-20

Terms related to this study

Keywords Provided by Researchers

  • Locally Advanced Resectable Gastroesophageal Adenocarcinoma
  • Gastroesophageal Junction
  • Neoadjuvant Treatment
  • Perioperative Treatment
  • Gastric cancer
  • Immune checkpoint inhibitors
  • Chemotherapy

Additional Relevant MeSH Terms

  • Gastroesophageal Adenocarcinoma