NCT07069712 · AstraZeneca
A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma
What this study is about
GEMINI-PeriOp GC study will assess the safety, tolerability, how the drug moves through the body (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.
View original scientific 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.
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.
Primary outcome measures
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Until sub-study completion, up to 38 months
To assess the safety and tolerability of perioperative treatment.
Percentage of participants with pathological complete response (pCR)
Time frame: Until sub-study completion, up to 38 months
pCR is defined as no viable cancer cells, including lymph nodes after complete evaluation in the resected gastric, GEJ, or esophageal cancer specimen and all sampled regional lymph nodes following neoadjuvant treatment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Histologically documented gastric, GEJ, or esophageal adenocarcinoma with resectable disease
- 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
- 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
Where
- Newark, Delaware
- Washington D.C., District of Columbia
- Fairway, Kansas
- North Shores, Michigan
- New York, New York
- Pittsburgh, Pennsylvania
Collaborators
Parexel
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations