Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507683
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Evaluate the Efficacy and Safety of Radiotherapy Combined With Ripretinib in the Treatment of Unresectable Advanced GIST
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Single-arm Prospective Study to Evaluate the Efficacy and Safety of Radiotherapy Combined With Ripretinib in the Treatment of Unresectable Advanced GIST
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this prospective study is to learn whether there is a synergistic effect when radiotherapy is combined with ripretinib in the treatment of patients with unresectable advanced GIST It will also learn about the safety of this regimenThe main questions it aim to answer is Dose radiotherapy combined with ripretinib prolong the time to disease progression for patients with advanced GIST
Detailed Description:
ripretinib is the standard fourth-line treatment agent for inoperable advanced GIST patients but the mPFS is only 63 months Prolonging the time to TKI resistance by using a new treatment approach is important to increase the chances of surgery improve the survival time and quality of life for patients GIST was previously thought to be a tumor that was insensitive to radiotherapy but a growing number of studies have shown that GIST is moderately sensitive to radiotherapy and that radiotherapy is effective in controlling the tumor In our previous work palliative radiotherapy was given to patients with advanced GIST after multiline drug resistance and we achieved local control for nearly 2 years while significantly improving the patients symptoms
In recent years radiotherapy technology has been continuously improved and new radiotherapy techniques can be more precise and have less impact on surrounding organs making it possible to increase the dose of radiotherapy For large GIST our research team has optimized the radiotherapy technique by using simultaneous integrated boost intensity-modulated radiotherapy technique which can deliver a safe dose at the edge of the tumor while delivering a high dose of radiotherapy at the center of the tumor ensuring safety and resulting in better therapeutic effects
We proposed to select some patients with unresectable advanced GIST to explore the feasibility of radiotherapy combined with TKI for the treatment of advanced GIST after failure of first- second- and third-line drug therapies with simultaneous addition of radiotherapy to oral ripretinib treatment
In recent years radiotherapy technology has been continuously improved and new radiotherapy techniques can be more precise and have less impact on surrounding organs making it possible to increase the dose of radiotherapy For large GIST our research team has optimized the radiotherapy technique by using simultaneous integrated boost intensity-modulated radiotherapy technique which can deliver a safe dose at the edge of the tumor while delivering a high dose of radiotherapy at the center of the tumor ensuring safety and resulting in better therapeutic effects
We proposed to select some patients with unresectable advanced GIST to explore the feasibility of radiotherapy combined with TKI for the treatment of advanced GIST after failure of first- second- and third-line drug therapies with simultaneous addition of radiotherapy to oral ripretinib treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None