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Novel perioperative drug combinations for locally advanced resectable gastric and gastroesophageal junction adenocarcinoma

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)

Phase 2 Interventional AstraZeneca · NCT07069712

This trial will test new drugs or drug combinations given before and around surgery for people with locally advanced, resectable stomach or gastroesophageal junction adenocarcinoma who haven't had prior treatment.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Locations70 sites (Newark, Delaware and 69 other locations)
Trial IDNCT07069712 on ClinicalTrials.gov

What this trial studies

This Phase II, open-label, multi-center platform tests multiple novel agents or combinations as perioperative therapy for patients with locally advanced resectable gastric, gastroesophageal junction, or esophageal adenocarcinoma who are treatment-naïve. Participants are assigned into one of three biomarker-driven sub-studies (CLDN18.2-positive/HER2-negative, HER2-positive, or unselected) and receive the recommended dose confirmed by a Safety Review Committee. The protocol collects data on safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity before and after surgery. Individual sub-studies can add or compare different agents such as trastuzumab deruxtecan, AZD0901, rilvegostomig, capecitabine, or 5-FU.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed, locally advanced but resectable gastric, GEJ, or esophageal adenocarcinoma with ECOG 0–1, adequate organ function, body weight >35 kg, and the biomarker profile required for the assigned sub-study.

Not a fit: Patients who have had prior treatment or surgery for the current cancer, have known distant metastases, active uncontrolled infections, interstitial lung disease, or autoimmune conditions needing systemic immunosuppression are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, these perioperative combinations could shrink tumors before surgery and lower the risk of recurrence, potentially improving long-term outcomes.

How similar studies have performed: Some agents—most notably trastuzumab deruxtecan in HER2-positive gastric cancer and CLDN18.2-directed therapies—have shown promise in advanced settings, but perioperative use in resectable disease is less well established.

Eligibility criteria

Show full inclusion / exclusion criteria 
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
* 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

Where this trial is running

Newark, Delaware and 69 other locations

+20 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Gastroesophageal AdenocarcinomaLocally Advanced Resectable Gastroesophageal AdenocarcinomaGastroesophageal JunctionNeoadjuvant TreatmentPerioperative TreatmentGastric cancerImmune checkpoint inhibitorsChemotherapy
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.