Resistance to Immunotherapy in Gastric Cancer
MERIT
Mechanisms of Resistance to Immunotherapy Based on Checkpoint Inhibitors in Metastatic Gastric Cancers
1 other identifier
observational
50
1 country
1
Brief Summary
This project seeks to analyze and define the mechanism (s) involved in the resistance to checkpoint therapy in metastatic GC patients. The investigators propose the use of a Next-Generation Sequencing (NGS) assay that involves 395 genes allowing us to define a specific molecular signature to characterize responder and non-responder patients to checkpoint therapy in combination with IHC analyses of specific factors. Such signature (s) could then be used to predict which individuals who might get the most benefit out of checkpoint therapy treatment. Analysis will be perfomed retrospectively using biopsies provided by mGC patients recruited at the Red de Salud UC treated with checkpoint therapy, the response of patients to treatment is evaluated by RECIST 1.1 criteria and thereby they are classified as "responders" or "non-responders".
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 4, 2018
CompletedFirst Submitted
Initial submission to the registry
July 30, 2018
CompletedFirst Posted
Study publicly available on registry
August 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedAugust 6, 2018
August 1, 2018
2 years
July 30, 2018
August 2, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Survival
Overall survival
3-12 weeks
Study Arms (1)
Immunotherapy responders/non-responders
paraffin samples and relevant clinical data including RECIST 1.1 will be obtained from metastatic gastric cancer patients
Interventions
paraffin samples will be collected retrospectively along with clinical data
Eligibility Criteria
Adult, chilean metastatic gastric cancer patients \>18 year-old, that received immunotherapy (checkpoint inhibitors) with clinical follow up for at least 6-12 weeks and categorized as responders or non-responders by RECIST 1. -
You may qualify if:
- Chilean residents, male or female \>18 yr-old
- Histologically confirmed metastatic gastric cancer
- Received immunotherapy using checkpoint inhibitors with clinical followup for at least 6 weeks
- Patients with paraffin samples or biopsies obtained form primary tumor
- Able to speak and understand Spanish and sign a written informed consent form
You may not qualify if:
- Patients without clinical records or no paraffin or biopsy sample
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro de Cancer UC CHRISTUS
Santiago, 8330032, Chile
Biospecimen
paraffin sections from primary tumors
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcelo Garrido, MD
Pontificia Universidad Catolica de Chile
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2018
First Posted
August 3, 2018
Study Start
July 4, 2018
Primary Completion
June 30, 2020
Study Completion
March 31, 2021
Last Updated
August 6, 2018
Record last verified: 2018-08