Gastrointestinal Stromal Tumors (GIST)
Conditions
Brief summary
Rate of Participants Achieving 3-Month Progression-Free Survival (PFSR) [Rate of participants who are progression-free at 3 months after the start of protocol therapy, using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria. Progression-free survival (PFS) is defined as the time from treatment initiation until documented disease progression or death (by any cause, in the absence of progression)].
Detailed description
Progression free survival (PFS) [time from treatment initiation to date of first documentation of progression of disease assessed by the Investigator (by RECIST version 1.1) or death due to any cause], Overall survival (OS) [time from the date of treatment initiation until the date of death from any cause], 1-year overall survival (OS) rate [proportion of patients that survive more than 1 year], Overall response rate (ORR) [ORR is defined as the proportion of patients with objective response [confirmed complete (CR) or partial response (PR) according to RECIST Version 1.1], Duration of response (DoR) [the time from documentation of tumor response to disease progression], Disease control rate (DCR) [patients whose best response was CR or PR or Stable Disease (SD)], Adverse events (graded according to the Common Toxicity Criteria for the Adverse Events, CTC-AE, version 4.0) assessed every 4 weeks, Relationship between PDL-1 expression and measures of efficacy, including ORR, DCR, PFS and OS, Relationship between biomarkers in blood/tissue and efficacy, including ORR, DCR, PFS and OS
Interventions
Sponsors
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Participants Achieving 3-Month Progression-Free Survival (PFSR) [Rate of participants who are progression-free at 3 months after the start of protocol therapy, using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria. Progression-free survival (PFS) is defined as the time from treatment initiation until documented disease progression or death (by any cause, in the absence of progression)]. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) [time from treatment initiation to date of first documentation of progression of disease assessed by the Investigator (by RECIST version 1.1) or death due to any cause], Overall survival (OS) [time from the date of treatment initiation until the date of death from any cause], 1-year overall survival (OS) rate [proportion of patients that survive more than 1 year], Overall response rate (ORR) [ORR is defined as the proportion of patients with objective response [confirmed complete (CR) or partial response (PR) according to RECIST Version 1.1], Duration of response (DoR) [the time from documentation of tumor response to disease progression], Disease control rate (DCR) [patients whose best response was CR or PR or Stable Disease (SD)], Adverse events (graded according to the Common Toxicity Criteria for the Adverse Events, CTC-AE, version 4.0) assessed every 4 weeks, Relationship between PDL-1 expression and measures of efficacy, including ORR, DCR, PFS and | — |
Countries
Italy, Poland
Outcome results
None listed