Safety and Efficacy of Avapritinib in Chinese Patients With Gastrointestinal Stromal Tumor (GIST) in the Real World

Study Overview
=================
Brief Summary
-----------------
This study is an observational, multicenter, Real-word study to evaluate the safety and clinical efficacy of avapritinib in Chinese subjects with GIST.

Official Title
-----------------
A National Multicenter, Noninterventional Clinical Study Evaluating the Safety and Efficacy of Avapritinib in Chinese Patients With Gastrointestinal Stromal Tumor (GIST) in the Real World

Conditions
-----------------
Gastrointestinal Stromal Tumors

Intervention / Treatment
-----------------
* Drug: Avapritinib
* Drug: Tyrosine kinase inhibitors other than avapritinib ( imatinib, sunitinib, et al )


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cohort 1 and 4: Participants must have a confirmed diagnosis of unresectable GIST with mutations in the PDGFRα gene exon 18. Cohort 2: Participants must have a confirmed diagnosis of GIST with mutations in the PDGFRα gene exon 18 and was/will be administrated avapritinib in an neoadjuvant and/or adjuvant setting. Cohort 3: Participants must have a confirmed diagnosis of unresectable GIST without mutations in the PDGFRα gene exon 18, KIT gene exon 13, and KIT gene exon 14. Exclusion Criteria: Participants who have participated and may participate in any other interventional clinical trail in the future. Participants with any comorbidities not suitable for avapritinib (other TKIs, Cohort 4) treatment assessed by researchers.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ava-mGSIT-P18<br>Unresectable or metastatic PDGFRA exon 18 GIST | Drug: Avapritinib<br>* Avapritinib will be administered orally at the starting of 300 mg once daily as the label recommended. Investigators can adjust the dosage, frequency, and duration as needed.<br>|
| Ava-Perioperative<br>Perioperative PDGFRA exon 18 GIST | Drug: Avapritinib<br>* Avapritinib will be administered orally at the starting of 300 mg once daily as the label recommended. Investigators can adjust the dosage, frequency, and duration as needed.<br>|
| Ava-mGIST-other<br>Unresectable or metastatic GIST without KIT exon 13，14，or PDGFRA exon 18 mutation | Drug: Avapritinib<br>* Avapritinib will be administered orally at the starting of 300 mg once daily as the label recommended. Investigators can adjust the dosage, frequency, and duration as needed.<br>|
| TKI<br>Unresectable or metastatic PDGFRA exon 18 GIST | Drug: Tyrosine kinase inhibitors other than avapritinib ( imatinib, sunitinib, et al )<br>* Investigators will decide which TKI to use as well as the dosage, frequency, and duration.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events(AE) and serious adverse events(SAE)in cohort 1, 2, and 3 |  | AEs were collected from the start of study drug until 30 days after the last dose, SAEs were collected from the date of the informed consent signature until 30 days after the last dose of study drug, up to 3 years. | 
| Dose adjustment of avapritinib in cohort 1, 2, and 3 |  | From the start of study drug until 30 days after the last dose, up to 3 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GIST, Avapritinib