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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05381753

Enrollment

Registered

2022-05-19

Start date

2022-08-29

Completion date

2024-09-30

Last updated

2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Stromal Tumors

Keywords

GIST, Avapritinib

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.

Interventions

DRUGAvapritinib

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.

DRUGTyrosine kinase inhibitors other than avapritinib ( imatinib, sunitinib, et al )

Investigators will decide which TKI to use as well as the dosage, frequency, and duration.

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026