Study on New Treatments Before Surgery for Locally Advanced Gastroesophageal Cancer

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT07069712

This clinical trial is testing new drugs or drug combinations given before surgery to see if they are safe and effective in treating locally advanced gastroesophageal cancer that can be surgically removed.

Patient Parameters

Program Overview

The GEMINI-PeriOp GC study is exploring the safety and effectiveness of new treatments given before surgery in patients with locally advanced gastroesophageal cancer. The study focuses on patients who have not received any previous treatment for their cancer and aims to find out how well these new treatments work in shrinking tumors before surgery.

Description

This Phase II study involves testing multiple new drugs or combinations of drugs in patients with locally advanced gastroesophageal cancer that can be surgically removed. The study is divided into different sub-studies, each testing different treatments. Participants will be assigned to one of three sub-studies to determine the best dose and effectiveness of the treatments. The study will help researchers understand how these new treatments can be used safely and effectively before surgery.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma that can be surgically removed.
  • For Sub-study 1, participants must be CLDN18.2-positive and HER2-negative; for Sub-study 2, participants must be HER2-positive; no specific requirements for Sub-study 3.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ and bone marrow function as determined by specific medical tests.
  • Weigh more than 35 kg (about 77 pounds).

Exclusion Criteria

  • Have received any prior treatment or surgery for the current gastric, GEJ, or esophageal cancer.
  • Have active or previously documented autoimmune or inflammatory disorders requiring treatment with steroids or other immunosuppressive drugs.
  • Have any central nervous system (CNS) disorders.
  • Have uncontrolled infections.
  • Have a history of lung diseases like interstitial lung disease (ILD) or pneumonitis, or currently have or are suspected to have these conditions.
  • Have a history of another primary cancer.
  • Have any known or suspected cancer spread to distant parts of the body.
  • Have uncontrolled hepatitis B or chronic or active hepatitis B.
  • Have used immunosuppressive medication within 14 days before starting the study treatment.

Locations

FACILITYZIPCITYSTATE
Research Site19713NewarkDelaware
Research Site20007Washington D.C.District of Columbia
Research Site66205FairwayKansas
Research Site49444North ShoresMichigan
Research Site10032New YorkNew York
Research Site10065New YorkNew York
Research Site15232PittsburghPennsylvania

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