Gastrointestinal Stromal TumorsNCT05697107
Ripretinib in Chinese Patients With Advanced GIST: a Real World Study
An observational study of Gastrointestinal Stromal Tumors, run by Peking University at 1 site in China.
Trial summary
to evaluate the clinical efficacy, safety and predictive factors of ripetinib in Chinese patients with advanced GIST in the real world 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?
- Ripretinib Oral Tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 308 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2021to 30 Dec 2023
- 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: Histologically confirmed gastrointestinal stromal tumor
Who may be able to join
- -≥18 years old
- Histologically confirmed gastrointestinal stromal tumor (GIST)
- At least one measurable lesion (mRECIST v1.1)
- Received or receiving ripretinib treatment
Who cannot join
- Patients who received <1 cycle of ripretinib treatment
- Medical records are incomplete
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Large Scale, Multicenter, Real-World Study on Patients With Advanced GIST Receiving Ripretinib
to evaluate the clinical efficacy, safety and predictive factors of ripetinib in Chinese patients with advanced GIST in the real world
Read the detailed description
Ripretinib has become the standard ≥ 4L treatment in advanced GIST. Given the small sample size of patients in the China bridging study of INVICTUS as well as the short marketing time of ripretinib, further exploration on the long-term efficacy and safety of ripretinib, as well as the dominant gene mutation type of ripretinib in Chinese GIST patients is required. Hence, we plan to further explore the efficacy of ripretinib, predictors of efficacy, etc. by collecting and analyzing real-world data from Chinese patients with advanced GIST recieving ripretinib.
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- Ripretinib Oral Tablet
- 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.
Ripretinib Oral TabletDrug
Oral kinase inhibitor
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
To assess the efficacy (progression-free survival [PFS]
Measured: approximately 7 months
Secondary outcomes (2)
DCR
To assess disease control rate (DCR)
Measured: approximately 6 months
OS
to assess median overall survival (mOS)
Measured: approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start20 May 2021
- Primary completion30 Aug 2022
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Sun Yat-sen University, Fudan University, Xiangya Hospital of Central South University, Fujian Medical University Union Hospital, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Zhejiang University, First Affiliated Hospital of Chongqing Medical University, RenJi Hospital
- Responsible party
- Principal investigator, Shen Lin, Peking University
- Investigators
- Lin Shen, MD, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697107
- Sponsor's protocol ID
- GIST-R-RWD-001
- Status last verified
- Jan 2023
- First submitted
- 15 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: UNDECIDED
Publications
Zhang X, Zhang P, Qiu H, Fang Y, Liu H, Zhou Y, Xu H, Yu J, Zhang J, Wang M, Shen L, Li J. Large-Scale, Multicenter, Prospective Registry Study of Ripretinib in Advanced GIST: A Real-World Study from China. Adv Ther. 2023 Sep;40(9):3817-3829. doi: 10.1007/s12325-023-02576-0. Epub 2023 Jun 25.
PubMed 37356078
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Large Scale, Multicenter, Real-World Study on Patients With Advanced GIST Receiving Ripretinib
- ClinicalTrials.gov ID
- NCT05697107
- Acronym / sponsor ID
- GIST-R-RWD-001
- Conditions
- Gastrointestinal Stromal Tumors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Sun Yat-sen University, Fudan University, Xiangya Hospital of Central South University, Fujian Medical University Union Hospital, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Zhejiang University, First Affiliated Hospital of Chongqing Medical University, RenJi Hospital
- Study start
- 20 May 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 25 Jan 2023 (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.
to evaluate the clinical efficacy, safety and predictive factors of ripetinib in Chinese patients with advanced GIST in the real world
Detailed description
Ripretinib has become the standard ≥ 4L treatment in advanced GIST. Given the small sample size of patients in the China bridging study of INVICTUS as well as the short marketing time of ripretinib, further exploration on the long-term efficacy and safety of ripretinib, as well as the dominant gene mutation type of ripretinib in Chinese GIST patients is required. Hence, we plan to further explore the efficacy of ripretinib, predictors of efficacy, etc. by collecting and analyzing real-world data from Chinese patients with advanced GIST recieving ripretinib.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically confirmed gastrointestinal stromal tumor
Key inclusion criteria (4 listed)
- -≥18 years old
- Histologically confirmed gastrointestinal stromal tumor (GIST)
- At least one measurable lesion (mRECIST v1.1)
- Received or receiving ripretinib treatment
Key exclusion criteria (2 listed)
- Patients who received <1 cycle of ripretinib treatment
- Medical records are incomplete
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 |
|---|---|---|
| Ripretinib Oral TabletOral kinase inhibitor | Drug | – |
Primary outcome
PFS
Time frame: approximately 7 months
To assess the efficacy (progression-free survival [PFS]
2 secondary outcomes
DCR
Time frame: approximately 6 months
OS
Time frame: approximately 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Derived from this study: PubMed 37356078Zhang X, Zhang P, Qiu H, Fang Y, Liu H, Zhou Y, Xu H, Yu J, Zhang J, Wang M, Shen L, Li J. Large-Scale, Multicenter, Prospective Registry Study of Ripretinib in Advanced GIST: A Real-World Study from China. Adv Ther. 2023 Sep;40(9):3817-3829. doi: 10.1007/s12325-023-02576-0. Epub 2023 Jun 25.
- Individual participant dataSharing planned: Undecided. UNDECIDED
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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.
Lin Shen, MD principal investigator
Peking University
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 Peking University 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 4 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: status not confirmed, as of the sponsor's last update on 25 Jan 2023. 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?
Results are not available in the source record.
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?
PFS (time frame: approximately 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05697107, which also lists 1 linked publication.
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 25 Jan 2023.