Clinical trial · Observational
Identification of Biomarkers for Prediction of Response or Resistance Against Target Therapy in Gastric Cancer
Identification of Biomarkers for Prediction of Response or Resistance Against Target Therapy in Adenocarcinoma of the Stomach or Gastroesophageal Junction. A Non-interventional Study
NCT02305043CI-TRIAL-00033708VARIANZcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to identify biomarkers predicting response or resistance factors of a targeted therapy with trastuzumab in advanced gastric cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| non-interventional | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Percentage of Participants With Objective Response
- timeFrame
- 12 months
- description
- Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least 30% decrease in the sum of the longest dimension of the target lesion
Secondary outcomes (2)
- measure
- time-to-progression
- timeFrame
- up to 24 months
- description
- The period from study entry until disease progression, death, or date of last contact.
- measure
- overall survival
- timeFrame
- up to 24 months
- description
- OS is the duration from enrollment to death.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically proven adenocarcinoma of the stomach or gastroesophageal junction * stage IV * patient receives chemotherapy * signed informed consent * Age \> 18 years Exclusion Criteria: * Patient can not understand meaning and purpose of the study * patient already received a chemotherapy treatment for advanced disease.
References
Publications (3)
- DERIVEDWang J, Sun N, Kunzke T, Shen J, Feuchtinger A, Wang Q, Meixner R, Gleut RL, Haffner I, Luber B, Lordick F, Walch A. Metabolic heterogeneity affects trastuzumab response and survival in HER2-positive advanced gastric cancer. Br J Cancer. 2024 Apr;130(6):1036-1045. doi: 10.1038/s41416-023-02559-6. Epub 2024 Jan 24. PMID 38267634
- DERIVEDEbert K, Haffner I, Zwingenberger G, Keller S, Raimundez E, Geffers R, Wirtz R, Barbaria E, Hollerieth V, Arnold R, Walch A, Hasenauer J, Maier D, Lordick F, Luber B. Combining gene expression analysis of gastric cancer cell lines and tumor specimens to identify biomarkers for anti-HER therapies-the role of HAS2, SHB and HBEGF. BMC Cancer. 2022 Mar 9;22(1):254. doi: 10.1186/s12885-022-09335-4. PMID 35264144
- DERIVEDHaffner I, Schierle K, Raimundez E, Geier B, Maier D, Hasenauer J, Luber B, Walch A, Kolbe K, Riera Knorrenschild J, Kretzschmar A, Rau B, Fischer von Weikersthal L, Ahlborn M, Siegler G, Fuxius S, Decker T, Wittekind C, Lordick F. HER2 Expression, Test Deviations, and Their Impact on Survival in Metastatic Gastric Cancer: Results From the Prospective Multicenter VARIANZ Study. J Clin Oncol. 2021 May 1;39(13):1468-1478. doi: 10.1200/JCO.20.02761. Epub 2021 Mar 25. PMID 33764808