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Study of New Treatments for Locally Advanced Gastroesophageal Adenocarcinoma

This study is looking at new treatments for locally advanced gastroesophageal adenocarcinoma (cancer of the stomach, where the esophagus meets the stomach, or the esophagus itself) that can be removed by surgery. Researchers are testing different combinations of drugs, including AZD0901, Rilvegostomig, Trastuzumab Deruxtecan (T-DXd), Capecitabine, and 5-Fluorouracil (5-FU). You might be able to join if you have this type of cancer, are 18 or older, and have not had previous treatment for it. Some parts of the study require your cancer to have specific biomarkers (HER2 or CLDN18.2). The main goals are to see how safe these treatments are and if they can completely get rid of the cancer before surgery.

Study design
This is a Phase II, open-label study, meaning both you and your doctors will know which treatment you are receiving. It is designed to test multiple new drugs or combinations in about 100 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and treatment response until the sub-study is completed, which could be up to 38 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07069712

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
AstraZeneca
~100 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:Sonesitatug VedotinRilvegostomigTrastuzumab Deruxtecan (T-DXd)Capecitabine5-Fluorouracil (5-FU)FLOT Chemotherapy

At a glance

Recruiting sites
54 of 70 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Measured over Until sub-study completion, up to 38 months
+1 more outcome measured

Conditions

Gastroesophageal Adenocarcinoma

Explore related trials

Esophageal AdenocarcinomaGastric CarcinomaGastroesophageal Junction AdenocarcinomaClaudin-18 Isoform A2

Where it's being run

70 sites across 17 states
China12
Japan11
Italy9
Spain9
United Kingdom5
Georgia4
Taiwan4
Turkey (Türkiye)4

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of participants with adverse events (AEs) and serious adverse events (SAEs)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)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.