Ripretinib Combined With Surgery in Advanced GIST That Have Failed Imatinib Therapy: A Multicenter,Observational Study
NCT ID: NCT05354388
Last Updated: 2022-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2021-10-01
2023-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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surgery after ripretinib treatment
For subjects who achieved PR or SD, perform resection of gastrointestinal stromal tumor
Resection surgery of gastrointestinal stromal tumor
oral administration of Ripretinib 150 mg QD. Resection of gastrointestinal stromal tumors was performed in patients who achieved PR or SD
Interventions
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Resection surgery of gastrointestinal stromal tumor
oral administration of Ripretinib 150 mg QD. Resection of gastrointestinal stromal tumors was performed in patients who achieved PR or SD
Eligibility Criteria
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Inclusion Criteria
2. 18 years ≤ age \< 75 years, male or female;
3. Histopathological examination confirmed the diagnosis of recurrent and/or metastatic advanced unresectable gastrointestinal stromal tumor;
4. According to the modified RECISTv1.1-GIST-specific criteria, the subject has at least one measurable lesion;
5. Subjects must have progressed on imatinib or have documented intolerance to imatinib.
6. ECOG PS of ≤ 2, ASA score ≤ 3 at screening;
7. No other malignant tumors occurred within five years;
Exclusion Criteria
2. Patients with other serious complications who cannot tolerate surgery: such as severe cardiopulmonary disease, heart function below clinical class 2, pulmonary infection, moderate to severe COPD, chronic bronchitis, severe diabetes and/or renal insufficiency, severe hepatitis and/or Child-pugh class C or B whose symptoms are significantly difficult to correct, severe malnutrition, etc;
3. Pregnant or lactating women;
4. Treatment with any other line of therapy in addition to imatinib for advanced GIST. Imatinib-containing combination therapy in the first-line treatment should not be enrolled.
5. Subject has known active central nervous system metastases.
6. Occurrence of bleeding, perforation, obstruction and other disease-related complications, requiring emergency surgery;
7. The patient has participated in or is participating in other clinical studies , or is taking other TKI agents;
18 Years
75 Years
ALL
No
Sponsors
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Sichuan Provincial People's Hospital
OTHER
Responsible Party
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Minghui Pang
Professor
Principal Investigators
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Minghui Pang, Professor
Role: PRINCIPAL_INVESTIGATOR
Sichuan Provincial People's Hospital
Locations
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Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Minghui Pang, Professor
Role: primary
References
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Rubin BP, Heinrich MC, Corless CL. Gastrointestinal stromal tumour. Lancet. 2007 May 19;369(9574):1731-41. doi: 10.1016/S0140-6736(07)60780-6.
Wozniak A, Rutkowski P, Piskorz A, Ciwoniuk M, Osuch C, Bylina E, Sygut J, Chosia M, Rys J, Urbanczyk K, Kruszewski W, Sowa P, Siedlecki J, Debiec-Rychter M, Limon J; Polish Clinical GIST Registry. Prognostic value of KIT/PDGFRA mutations in gastrointestinal stromal tumours (GIST): Polish Clinical GIST Registry experience. Ann Oncol. 2012 Feb;23(2):353-60. doi: 10.1093/annonc/mdr127. Epub 2011 Apr 28.
Reichardt P. The Story of Imatinib in GIST - a Journey through the Development of a Targeted Therapy. Oncol Res Treat. 2018;41(7-8):472-477. doi: 10.1159/000487511. Epub 2018 Jun 13.
Sciot R, Debiec-Rychter M, Daugaard S, Fisher C, Collin F, van Glabbeke M, Verweij J, Blay JY, Hogendoorn PC; EORTC Soft Tissue and Bone Sarcoma Group; Italian Sarcoma Group; Australasian Trials Group. Distribution and prognostic value of histopathologic data and immunohistochemical markers in gastrointestinal stromal tumours (GISTs): An analysis of the EORTC phase III trial of treatment of metastatic GISTs with imatinib mesylate. Eur J Cancer. 2008 Sep;44(13):1855-60. doi: 10.1016/j.ejca.2008.06.003. Epub 2008 Jul 22.
Bucher P, Villiger P, Egger JF, Buhler LH, Morel P. Management of gastrointestinal stromal tumors: from diagnosis to treatment. Swiss Med Wkly. 2004 Mar 20;134(11-12):145-53. doi: 10.4414/smw.2004.10530.
Martin-Broto J, Moura DS. New drugs in gastrointestinal stromal tumors. Curr Opin Oncol. 2020 Jul;32(4):314-320. doi: 10.1097/CCO.0000000000000642.
Dhillon S. Ripretinib: First Approval. Drugs. 2020 Jul;80(11):1133-1138. doi: 10.1007/s40265-020-01348-2.
Mantese G. Gastrointestinal stromal tumor: epidemiology, diagnosis, and treatment. Curr Opin Gastroenterol. 2019 Nov;35(6):555-559. doi: 10.1097/MOG.0000000000000584.
Serrano C, George S. Recent advances in the treatment of gastrointestinal stromal tumors. Ther Adv Med Oncol. 2014 May;6(3):115-27. doi: 10.1177/1758834014522491.
Bannon AE, Klug LR, Corless CL, Heinrich MC. Using molecular diagnostic testing to personalize the treatment of patients with gastrointestinal stromal tumors. Expert Rev Mol Diagn. 2017 May;17(5):445-457. doi: 10.1080/14737159.2017.1308826. Epub 2017 Mar 27.
Den Hollander D, Van der Graaf WTA, Desar IME, Le Cesne A. Predictive factors for toxicity and survival of second-line sunitinib in advanced gastrointestinal stromal tumours (GIST). Acta Oncol. 2019 Nov;58(11):1648-1654. doi: 10.1080/0284186X.2019.1637017. Epub 2019 Jul 26.
Janku F, Abdul Razak AR, Chi P, Heinrich MC, von Mehren M, Jones RL, Ganjoo K, Trent J, Gelderblom H, Somaiah N, Hu S, Rosen O, Su Y, Ruiz-Soto R, Gordon M, George S. Switch Control Inhibition of KIT and PDGFRA in Patients With Advanced Gastrointestinal Stromal Tumor: A Phase I Study of Ripretinib. J Clin Oncol. 2020 Oct 1;38(28):3294-3303. doi: 10.1200/JCO.20.00522. Epub 2020 Aug 17.
Blay 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.
Other Identifiers
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20211013
Identifier Type: -
Identifier Source: org_study_id