Actively Recruiting
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
Led by AstraZeneca · Updated on 2026-05-18
100
Participants Needed
70
Research Sites
83 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
P
Parexel
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, how the body processes, and early anti-tumor effects of new drugs or drug combinations given around the time of surgery in adults with locally advanced gastric, gastroesophageal junction GEJ, or esophageal adenocarcinoma who have not been treated before. This phase II, open-label study includes multiple sub-studies to assess different novel treatments. Participants are assigned to sub-studies based on the recommended dose determined by a safety review. Participants receive one of three treatment plans that combine novel drugs and chemotherapy before surgery neoadjuvant and after surgery adjuvant. One group receives AZD0901 plus Rilvegostomig with either 5-FU or Capecitabine another receives Trastuzumab Deruxtecan T-DXd plus Rilvegostomig with 5-FU or Capecitabine the third group receives Rilvegostomig plus FLOT chemotherapy. After initial combination therapy, all groups continue with Rilvegostomig alone in the adjuvant phase. Treatments are given through intravenous infusions or orally, depending on the drug. During the study, participants undergo surgery as planned and are monitored for side effects, tumor response, and survival outcomes up to 38 months. Researchers collect data on adverse events, tumor shrinkage, surgery success rates, event-free and disease-free survival, and overall survival. Blood samples are taken to measure drug levels and immune responses. Participants are followed closely to assess treatment safety and effectiveness throughout the study period.
CONDITIONS
Brief Title
A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically documented gastric, gastroesophageal junction, or esophageal adenocarcinoma with resectable disease
- CLDN18.2-positive and HER2-negative for Sub-study 1 or HER2-positive for Sub-study 2; no specific biomarker requirements for Sub-study 3
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and bone marrow function
- Body weight greater than 35 kg
- Age 18 years or older
You will not qualify if you...
- Prior anti-cancer treatment or surgery for current gastric, gastroesophageal junction, or esophageal cancer
- Active or prior autoimmune or inflammatory disorders requiring systemic steroids or immunosuppressive treatment
- Central nervous system pathology
- Uncontrolled infections
- History or current interstitial lung disease (ILD) or pneumonitis
- History of another primary malignancy
- Known or suspected distant metastasis
- Uncontrolled or chronic active hepatitis B
- Use of immunosuppressive medication within 14 days before first study drug dose
Research Team
A
AstraZeneca Clinical Study Information Center
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