Gastrointestinal Stromal TumorsNCT06507683
Evaluate the Efficacy and Safety of Radiotherapy Combined With Ripretinib in the Treatment of Unresectable Advanced GIST
A study testing simultaneous integrated boost intensity-modulated radiation therapy combined with ripretinib in people with Gastrointestinal Stromal Tumors, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Stromal Tumors
- What is being tested?
- simultaneous integrated boost intensity-modulated radiation therapy combined with ripretinib
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 28 May 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Jun Zhang, MD, +86 136 1766 6067, zjun2323@sina.cn
About this study
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
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?
Read the 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
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- simultaneous integrated boost intensity-modulated radiation therapy combined with ripretinib
- 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.
simultaneous integrated boost intensity-modulated radiation therapy combined with ripretinibRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy combined with ripretinib group | Experimental | Radiotherapy (50-70Gy/25-30f)+ ripretinib(150mg QD) Receives: Radiation: simultaneous integrated boost intensity-modulated radiation therapy combined with ripretinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to disease progression of irradiated lesions
Time from start of radiotherapy to progression of irradiated lesions
Measured: Approximately 12 months since the first subject enrolled
Secondary outcomes (3)
Time to disease progression of any lesions
Time from start of radiotherapy to progression of any lesions
Measured: Approximately 12 months since the first subject enrolled
Overall survival (OS)
the time from start of radiotherapy to all-cause death.
Measured: Approximately 12 months since the first subject enrolled
Objective Response Rate(ORR) of irradiated lesions
the percentage of patients whose efficacy is confirmed as complete response(CR) or partial responses(PR) based on mRECIST 1.1
Measured: Approximately 12 months since the first subject enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start28 May 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 First Affiliated Hospital of Chongqing Medical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute
- Responsible party
- Principal investigator, Jun Zhang, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Jun Zhang, Principal investigator, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507683
- Sponsor's protocol ID
- 1.0 /2024.05.01
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hayashi Y, Nguyen VTT. A narrative review of imatinib-resistant gastrointestinal stromal tumors. Gastrointest Stromal Tumor. 2021 Oct;4:6. doi: 10.21037/gist-21-10. Epub 2021 Oct 30.
PubMed 35814621Blay JY, Serrano C, Heinrich MC, Zalcberg J, Bauer S, Gelderblom H, Schoffski P, Jones RL, Attia S, D'Amato G, Chi P, Reichardt P, Meade J, Shi K, Ruiz-Soto R, George S, von Mehren M. Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 Jul;21(7):923-934. doi: 10.1016/S1470-2045(20)30168-6. Epub 2020 Jun 5.
PubMed 32511981Joensuu H, Eriksson M, Collan J, Balk MH, Leyvraz S, Montemurro M. Radiotherapy for GIST progressing during or after tyrosine kinase inhibitor therapy: A prospective study. Radiother Oncol. 2015 Aug;116(2):233-8. doi: 10.1016/j.radonc.2015.07.025. Epub 2015 Jul 27.
PubMed 26228971Gatto L, Nannini M, Saponara M, Di Scioscio V, Beltramo G, Frezza GP, Ercolani G, Pinna AD, Astolfi A, Urbini M, Brandi G, Biasco G, Pantaleo MA. Radiotherapy in the management of gist: state of the art and new potential scenarios. Clin Sarcoma Res. 2017 Jan 10;7:1. doi: 10.1186/s13569-016-0065-z. eCollection 2017.
PubMed 28078078Li L, Yi X, Cui H, Zhao X, Dang J, Jiang Q, Li Y. Simultaneous Integrated Boost Intensity-Modulated Radiotherapy for Locally Advanced Drug-Resistant Gastrointestinal Stromal Tumors: A Feasibility Study. Front Oncol. 2020 Nov 23;10:545892. doi: 10.3389/fonc.2020.545892. eCollection 2020.
PubMed 33330024Cui H, Li Y, Huang W, Lu W, Yi X. Escalation of radiotherapy dose in large locally advanced drug-resistant gastrointestinal stromal tumors by multi-shell simultaneous integrated boost intensity-modulated technique: a feasibility study. Radiat Oncol. 2022 Dec 28;17(1):216. doi: 10.1186/s13014-022-02179-z.
PubMed 36578008Boruban C, Sencan O, Akmansu M, Atik ET, Ozbek S. Metastatic gastrointestinal stromal tumor with long-term response after treatment with concomitant radiotherapy and imatinib mesylate. Anticancer Drugs. 2007 Sep;18(8):969-72. doi: 10.1097/CAD.0b013e3280e94982.
PubMed 17667604
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06507683
- Acronym / sponsor ID
- 1.0 /2024.05.01
- Conditions
- Gastrointestinal Stromal Tumors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute
- Study start
- 28 May 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 18 Jul 2024 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy combined with ripretinib group | Experimental | Radiation: simultaneous integrated boost intensity-modulated radiation therapy combined with ripretinibRadiotherapy (50-70Gy/25-30f)+ ripretinib(150mg QD) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| simultaneous integrated boost intensity-modulated radiation therapy combined with ripretinibA 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 | Radiation | Radiotherapy combined with ripretinib group |
Primary outcome
Time to disease progression of irradiated lesions
Time frame: Approximately 12 months since the first subject enrolled
Time from start of radiotherapy to progression of irradiated lesions
3 secondary outcomes
Time to disease progression of any lesions
Time frame: Approximately 12 months since the first subject enrolled
Overall survival (OS)
Time frame: Approximately 12 months since the first subject enrolled
Objective Response Rate(ORR) of irradiated lesions
Time frame: Approximately 12 months since the first subject enrolled
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Background: PubMed 35814621Hayashi Y, Nguyen VTT. A narrative review of imatinib-resistant gastrointestinal stromal tumors. Gastrointest Stromal Tumor. 2021 Oct;4:6. doi: 10.21037/gist-21-10. Epub 2021 Oct 30.
- Background: PubMed 32511981Blay JY, Serrano C, Heinrich MC, Zalcberg J, Bauer S, Gelderblom H, Schoffski P, Jones RL, Attia S, D'Amato G, Chi P, Reichardt P, Meade J, Shi K, Ruiz-Soto R, George S, von Mehren M. Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 Jul;21(7):923-934. doi: 10.1016/S1470-2045(20)30168-6. Epub 2020 Jun 5.
- Background: PubMed 26228971Joensuu H, Eriksson M, Collan J, Balk MH, Leyvraz S, Montemurro M. Radiotherapy for GIST progressing during or after tyrosine kinase inhibitor therapy: A prospective study. Radiother Oncol. 2015 Aug;116(2):233-8. doi: 10.1016/j.radonc.2015.07.025. Epub 2015 Jul 27.
- Background: PubMed 28078078Gatto L, Nannini M, Saponara M, Di Scioscio V, Beltramo G, Frezza GP, Ercolani G, Pinna AD, Astolfi A, Urbini M, Brandi G, Biasco G, Pantaleo MA. Radiotherapy in the management of gist: state of the art and new potential scenarios. Clin Sarcoma Res. 2017 Jan 10;7:1. doi: 10.1186/s13569-016-0065-z. eCollection 2017.
- Background: PubMed 33330024Li L, Yi X, Cui H, Zhao X, Dang J, Jiang Q, Li Y. Simultaneous Integrated Boost Intensity-Modulated Radiotherapy for Locally Advanced Drug-Resistant Gastrointestinal Stromal Tumors: A Feasibility Study. Front Oncol. 2020 Nov 23;10:545892. doi: 10.3389/fonc.2020.545892. eCollection 2020.
- Background: PubMed 36578008Cui H, Li Y, Huang W, Lu W, Yi X. Escalation of radiotherapy dose in large locally advanced drug-resistant gastrointestinal stromal tumors by multi-shell simultaneous integrated boost intensity-modulated technique: a feasibility study. Radiat Oncol. 2022 Dec 28;17(1):216. doi: 10.1186/s13014-022-02179-z.
- Background: PubMed 17667604Boruban C, Sencan O, Akmansu M, Atik ET, Ozbek S. Metastatic gastrointestinal stromal tumor with long-term response after treatment with concomitant radiotherapy and imatinib mesylate. Anticancer Drugs. 2007 Sep;18(8):969-72. doi: 10.1097/CAD.0b013e3280e94982.
- Individual participant dataSharing planned: No
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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.
Jun Zhang principal investigator
First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simultaneous integrated boost intensity-modulated radiation therapy combined with ripretinib in people with Gastrointestinal Stromal Tumors, run by First Affiliated Hospital of Chongqing Medical 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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 18 Jul 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Zhang, MD (+86 136 1766 6067, zjun2323@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to disease progression of irradiated lesions (time frame: Approximately 12 months since the first subject enrolled). 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 NCT06507683, which also lists 7 linked publications.
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 18 Jul 2024.