Phase 2Recruiting
A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal 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)
- Sponsor
- AstraZeneca (Industry)
- Enrolment
- 100 planned
- Conditions
- Gastroesophageal Adenocarcinoma
- Interventions
- Sonesitatug Vedotin; Rilvegostomig; Trastuzumab Deruxtecan (T-DXd); Capecitabine; 5-Fluorouracil (5-FU); FLOT Chemotherapy; Calcium folinate
- Ages
- adults, older adults
- Registry
- NCT07069712, CTIS2024-516909-23-00
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)
- Percentage of participants with pathological complete response (pCR)
History
Study completion expected
Primary completion expected
Last registry update
Registered
Started