NCT07858500Toborzás még nem indult
Zolbetuximab and Other Cancer Treatments in People With Advanced Gastric or GEJ Cancer in Clinical Practice (RADIANCE)
Real-world Clinical Outcomes, Patient Characteristics, and Treatment Patterns Among Patients With Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2-negative, Claudin-18 Isoform 2-positive Gastric or Gastroesophageal Junction Adenocarcinoma Treated With Zolbetuximab or Other First Line Treatments: A Cohort Study Using Secondary Data in Europe and Canada
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 28.
Rövid összefoglaló (regiszter, angolul)
There is an unmet medical need to treat people with advanced cancer in the stomach, or where the food pipe joins the stomach. These conditions are known as advanced gastric cancer or advanced gastroesophageal cancer (GEJ for short). Zolbetuximab is an approved treatment for people with advanced stomach (gastric) cancer or advanced GEJ cancer. Some people with stomach or GEJ cancer have a protein called Claudin 18.2 in their tumor. Zolbetuximab works by attaching to the Claudin 18.2 protein in their tumor. This switches on the body's immune system to attack the tumor. The main aim of the study is to collect information about zolbetuximab and other cancer treatments in people with advanced gastric or GEJ cancer. This includes safety information, how long people respond to treatment and how long people live for without their cancer getting worse. This study is about collecting information only. This is known as an observational study. The individual's doctor decides on treatment, not the sponsor (Astellas). This study will use information from European and Canadian health registries and databases to learn more about people with advanced gastric or GEJ cancers who used zolbetuximab and other cancer treatments. The entire study will last about 4 years.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 1000 (tervezett)
- Első benyújtás
- 2026. szept. 29.
- Kezdés
- 2027. jan. 31.
- Elsődleges befejezés
- 2029. jún. 30.
- Fő szponzor
- Astellas Pharma Europe Ltd.
- Betegségek
- Gyomor- és nyelőcsőrák
- NCT-szám
- NCT07858500
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 1000
- 2027. jan. 31. és az elsődleges befejezés (2029. jún. 30.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Evidence of any other primary malignancy in the 5 years prior to and including the index date, as identified according to ICD-10 codes or data source equivalent and excluding non-melanoma skin cancer (ICD-10 code C44.x).
- Cohort A only:
- Evidence that 1L treatment with zolbetuximab was received as part of a clinical trial.
- Cohort B only:
- Evidence that 1L treatment was received as part of a clinical trial.
- Cohort C only:
- Evidence that zolbetuximab was received as part of a clinical trial.
Egyéb
- Cohorts A, B and C:
Kiket keres a vizsgálat
- Cohorts A, B and C:
- Incident diagnosis of G/GEJ adenocarcinoma, as identified according to ICD-10 diagnosis codes (C16.x, C15.2, C15.5, C15.8, C15.9) and ICD for Oncology Third Edition (ICD-O-3) morphology codes (8140-8149, 8160-8162, 8190-8221, 8260-8337, 8350 8551, 8570-8576, 8940-8941) or data source equivalent.
- At least 18 years of age at the date of 1L treatment initiation.
- Cohorts A and B:
- Evidence of unresectable stage 3 or stage 4 disease.
- Evidence of HER2(-) tumor any time prior to and including the date of 1L treatment initiation.
- Evidence of CLDN18.2-positive tumor, defined as ≥75% of tumor cells showing moderate (2+) or strong (3+) membranous staining by IHC, assessed prior to or on the date of 1L treatment initiation.
- Cohort A only:
- 1L treatment with zolbetuximab in combination with platinum-fluoropyrimidine doublet chemotherapy which begins during the patient enrolment period.
- Cohort B only:
- 1L treatment that does not include zolbetuximab which begins during the patient enrolment period.
- Cohort C only:
- Zolbetuximab administered during the patient enrolment period under any of the following off-label conditions:
- NOT delivered in 1L for la/m disease and/or
- NOT delivered in combination with platinum-fluoropyrimidine doublet, and/or
- Delivered in combination with any systemic anti-cancer treatment that is not platinum-fluoropyrimidine doublet, and/or
- NOT delivered to a patient with evidence of HER2(-) tumor any time prior to and including the date of zolbetuximab initiation, and/or
- NOT delivered to a patient with evidence of CLDN18.2(+)-positive tumor, defined as ≥75% of tumor cells demonstrating moderate (2+) or strong (3+) membranous staining by IHC, assessed prior to or on the date of zolbetuximab initiation.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Research Institution | Alberta | Kanada | Ismeretlen állapot |
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