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A Master Protocol for 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)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516909-23-00
Acronym
D9804C00001
Enrollment
17
Registered
2025-09-01
Start date
2025-10-28
Completion date
Unknown
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Resectable Gastroesophageal Adenocarcinoma

Brief summary

-The measures of interest include the incidence of AEs and SAEs, and descriptive statistics summarizing laboratory findings, vital signs, and ECGs., -The analysis will include participants in mITT. -The measure of interest is the pCR rate, which is the proportion of participants with 0% residual viable tumor cells within all resected tissue.

Interventions

DRUGDS-8201a
DRUGRilvegostomig

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
-The measures of interest include the incidence of AEs and SAEs, and descriptive statistics summarizing laboratory findings, vital signs, and ECGs., -The analysis will include participants in mITT. -The measure of interest is the pCR rate, which is the proportion of participants with 0% residual viable tumor cells within all resected tissue.

Countries

Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026