Clinical trial · Interventional
Evaluate the Efficacy and Safety of Radiotherapy Combined With Ripretinib in the Treatment of Unresectable Advanced GIST
A Multicenter, Single-arm, Prospective Study to Evaluate the Efficacy and Safety of Radiotherapy Combined With Ripretinib in the Treatment of Unresectable Advanced GIST
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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?
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Stromal Tumors | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| simultaneous integrated boost intensity-modulated radiation therapy combined with ripretinib | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy combined with ripretinib group
- description
- Radiotherapy (50-70Gy/25-30f)+ ripretinib(150mg QD)
- interventionNames
- Radiation: simultaneous integrated boost intensity-modulated radiation therapy combined with ripretinib
Primary outcomes (1)
- measure
- Time to disease progression of irradiated lesions
- timeFrame
- Approximately 12 months since the first subject enrolled
- description
- Time from start of radiotherapy to progression of irradiated lesions
Secondary outcomes (3)
- measure
- Time to disease progression of any lesions
- timeFrame
- Approximately 12 months since the first subject enrolled
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDHayashi 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. PMID 35814621
- BACKGROUNDBlay 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. PMID 32511981
- BACKGROUNDJoensuu 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. PMID 26228971
- BACKGROUNDGatto 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. PMID 28078078
- BACKGROUNDLi 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. PMID 33330024
- BACKGROUNDCui 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.