Gastrointestinal Stromal TumorsNCT05381753
Safety and Efficacy of Avapritinib in Chinese Patients With Gastrointestinal Stromal Tumor (GIST) in the Real World
An observational study of Gastrointestinal Stromal Tumors, run by CStone Pharmaceuticals at 1 site in China.
Trial summary
This study is an observational, multicenter, Real-word study to evaluate the safety and clinical efficacy of avapritinib in Chinese subjects with GIST. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumors
- What is being tested?
- Avapritinib and Tyrosine kinase inhibitors other than avapritinib ( imatinib, sunitinib, et al )
- Type of treatment
- Pill or oral medicine
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 29 Aug 2022to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: GIST patients with specific genetic mutations who were treated or will be treated with avapritinib (other TKIs in corhort 4) in about 20 hospitals from 1 May 2021 to 31 Aug. 2023.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
This study is an observational, multicenter, Real-word study to evaluate the safety and clinical efficacy of avapritinib in Chinese subjects with GIST.
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- Avapritinib, Tyrosine kinase inhibitors other than avapritinib ( imatinib, sunitinib, et al )
- Keywords
- GIST, Avapritinib
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvapritinibDrug
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.
Tyrosine kinase inhibitors other than avapritinib ( imatinib, sunitinib, et al )Drug
Investigators will decide which TKI to use as well as the dosage, frequency, and duration.
| Study group | Role | What they receive |
|---|---|---|
| Ava-mGSIT-P18 | Unresectable or metastatic PDGFRA exon 18 GIST Receives: Drug: Avapritinib | |
| Ava-Perioperative | Perioperative PDGFRA exon 18 GIST Receives: Drug: Avapritinib | |
| Ava-mGIST-other | Unresectable or metastatic GIST without KIT exon 13，14，or PDGFRA exon 18 mutation Receives: Drug: Avapritinib | |
| TKI | Unresectable or metastatic PDGFRA exon 18 GIST Receives: Drug: Tyrosine kinase inhibitors other than avapritinib ( imatinib, sunitinib, et al ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events(AE) and serious adverse events(SAE)in cohort 1, 2, and 3
Measured: 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
Measured: From the start of study drug until 30 days after the last dose, up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start29 Aug 2022
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- CStone Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381753
- Sponsor's protocol ID
- Avapritinib-4-001
- Status last verified
- Nov 2024
- First submitted
- 9 May 2022
- Last updated
- 11 Feb 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05381753
- Acronym / sponsor ID
- Avapritinib-4-001
- Conditions
- Gastrointestinal Stromal Tumors
- Keywords
- GIST, Avapritinib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- CStone PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an observational, multicenter, Real-word study to evaluate the safety and clinical efficacy of avapritinib in Chinese subjects with GIST.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ava-mGSIT-P18 | – | Drug: AvapritinibUnresectable or metastatic PDGFRA exon 18 GIST |
| Ava-Perioperative | – | Drug: AvapritinibPerioperative PDGFRA exon 18 GIST |
| Ava-mGIST-other | – | Drug: AvapritinibUnresectable or metastatic GIST without KIT exon 13，14，or PDGFRA exon 18 mutation |
| TKI | – | Drug: Tyrosine kinase inhibitors other than avapritinib ( imatinib, sunitinib, et al )Unresectable or metastatic PDGFRA exon 18 GIST |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- GIST patients with specific genetic mutations who were treated or will be treated with avapritinib (other TKIs in corhort 4) in about 20 hospitals from 1 May 2021 to 31 Aug. 2023.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvapritinibAvapritinib 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. | Drug | Ava-Perioperative, Ava-mGIST-other, Ava-mGSIT-P18 |
| Tyrosine kinase inhibitors other than avapritinib ( imatinib, sunitinib, et al )Investigators will decide which TKI to use as well as the dosage, frequency, and duration. | Drug | TKI |
Primary outcome
Incidence and severity of adverse events(AE) and serious adverse events(SAE)in cohort 1, 2, and 3
Time frame: 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
Time frame: From the start of study drug until 30 days after the last dose, up to 3 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Stromal Tumors, run by CStone Pharmaceuticals at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events(AE) and serious adverse events(SAE)in cohort 1, 2, and 3 (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.