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Trial Title:
Evaluate the Efficacy and Safety of Radiotherapy Combined With Ripretinib in the Treatment of Unresectable Advanced GIST
NCT ID:
NCT06507683
Condition:
Gastrointestinal Stromal Tumors
Conditions: Official terms:
Gastrointestinal Stromal Tumors
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
simultaneous integrated boost intensity-modulated radiation therapy combined with ripretinib
Description:
A cumulative radiation dose of 50 to 70 Gy is administered in 25-30 fractions, 5
fractions per week, to the target lesion(s).
ripretinib: oral 150mg QD
Arm group label:
Radiotherapy combined with ripretinib group
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 regimen.The 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 6.3 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 patient's 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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Voluntary participation and signed informed consent;
- age: 18 to 75 years, Male or female
- Patients with histologically confirmed GIST and Imaging evaluated as unresectable
recurrent and metastatic disease or locally advanced.
- ECOG Performance Score: 0-2
- Subjects who have progressed or documented intolerance after previous first-line,
second-line, and third-line treatments.
- At least one measurable lesion in the abdominal or pelvic cavity that has progressed
after frontline treatment
- Adequate organ function and bone marrow reserve
Exclusion Criteria:
- estimated life-expectancy less than 3 months.
- Patients who have received previous radiotherapy to the proposed radiotherapy site,
or the tumor has significant mobility, poor tolerance of radiotherapy in adjacent
organs, and who are considered unsuitable for radiotherapy after MDT discussion
- Any other clinically significant comorbidities, which in the judgment of the
investigator, could compromise compliance with the protocol, interfere with
interpretation of the study results, or predispose the patient to safety risks.
- If female, the patient is pregnant or lactating, or plans to become pregnant during
the study treatment period
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Chongqing Medical University
Address:
City:
Chongqing
Zip:
400016
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Zhang, MD
Phone:
+86 136 1766 6067
Email:
zjun2323@sina.cn
Start date:
May 28, 2024
Completion date:
July 2027
Lead sponsor:
Agency:
First Affiliated Hospital of Chongqing Medical University
Agency class:
Other
Collaborator:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
First Affiliated Hospital of Chongqing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06507683
