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Recruiting Phase 2 NCT07069712

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

Phase 2 – studying effectiveness and dosage
Conditions: Gastroesophageal Adenocarcinoma

Sponsor: AstraZeneca

trial.available_in: БГ
Overview
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.
Description
This Phase II, open-label, multi-drug, multi-center platform study consists of individual sub-studies, each allows the assessment of multiple novel agents or novel combinations. Participants will be assigned across 3 sub-studies, to have sufficient evaluable participants of the confirmed recommended dose by Safety Review Committee (SRC) for study intervention in each corresponding sub-study.
Who can participate
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
Interventions
AZD0901
DRUG
Rilvegostomig
DRUG
Trastuzumab Deruxtecan (T-DXd)
DRUG
Capecitabine
DRUG
5-Fluorouracil (5-FU)
DRUG
FLOT Chemotherapy
DRUG
Locations 70
Canada (3)
Research Site
Montreal , Quebec
Research Site
Montreal , Quebec
Research Site
Toronto , Ontario
SUSPENDED
China (12)
Research Site
Beijing
Research Site
Changchun
Research Site
Changzhi
Research Site
Chengdu
Research Site
Chengdu
Research Site
Fuzhou
NOT_YET_RECRUITING
Research Site
Hangzhou
Research Site
Hangzhou
Research Site
Kunming
Research Site
Qingdao
Research Site
Shanghai
Research Site
Shijiazhuang
WITHDRAWN
Georgia (4)
Research Site
Tbilisi
Research Site
Tbilisi
Research Site
Tbilisi
Research Site
Tbilisi
Italy (9)
Research Site
Florence
Research Site
Milan
Research Site
Milan
Research Site
Milan
Research Site
Modena
WITHDRAWN
Research Site
Pisa
Research Site
Rozzano
Research Site
Udine
NOT_YET_RECRUITING
Research Site
Vicenza
Japan (11)
Research Site
Chūōku
Research Site
Fukuoka
Research Site
Hidaka-shi
Research Site
Kashiwa
Research Site
Kitaadachi-gun
Research Site
Kōtoku
NOT_YET_RECRUITING
Research Site
Nagoya
Research Site
Osaka
Research Site
Osaka
WITHDRAWN
Research Site
Suita-shi
Research Site
Yokohama
Poland (2)
Research Site
Bialystok
WITHDRAWN
Research Site
Warsaw
WITHDRAWN
Spain (9)
Research Site
Barcelona
Research Site
Barcelona
Research Site
Elche
Research Site
Madrid
Research Site
Málaga
Research Site
Ourense
Research Site
Oviedo
Research Site
Santander
Research Site
Valencia
Taiwan (4)
Research Site
Kaohsiung City
Research Site
Tainan
Research Site
Taipei
Research Site
Taoyuan District
Turkey (4)
Research Site
Adapazarı
WITHDRAWN
Research Site
Erzurum
WITHDRAWN
Research Site
Fatih-Istanbul
WITHDRAWN
Research Site
Istanbul
WITHDRAWN
United Kingdom (5)
Research Site
Bristol
WITHDRAWN
Research Site
Dundee
Research Site
Headington
Research Site
London
NOT_YET_RECRUITING
Research Site
Norwich
United States (7)
Research Site
Fairway , Kansas
Research Site
New York , New York
NOT_YET_RECRUITING
Research Site
New York , New York
Research Site
Newark , Delaware
Research Site
North Shores , Michigan
Research Site
Pittsburgh , Pennsylvania
NOT_YET_RECRUITING
Research Site
Washington D.C. , District of Columbia
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
17.07.2025
Completion date
06.09.2028
Registry ID
NCT07069712
Source
clinicaltrials.gov
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