NCT05354388|Unknown
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Sponsor study identifier
observational
30
1 country
1
Study Start
October 1, 2021
Actual (reported)Primary Completion
December 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The objective of this observational study is to explore the efficacy and safety of ripretinib treatment combined with surgery in advanced gastrointestinal stromal tumors(GIST) after failure of imatinib therapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2021
Actual (reported)April 25, 2022
Actual (reported)April 29, 2022
Actual (reported)December 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
1-year Progression free survival rate
PFS Based on radiographic assessment using Choi criteria
12 monthes
objective response rate（ORR）
12 monthes
R0 resection rate
1 days after surgery
2-year overall survival rate
24 monthes
time to progression (TTP)
12 monthes
Duration of continuous medication before surgery
12 monthes
For subjects who achieved PR or SD, perform resection 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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The patients enrolled in this study will be outpatients from Sichuan Provincial People's Hospital and cooperative hospitals
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
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.
Minghui Pang, Professor
Sichuan Provincial People's Hospital
First Submitted
April 25, 2022
First Posted
April 29, 2022
Study Start
October 1, 2021
Actual (reported)Primary Completion
December 30, 2023
Estimated (date passed)Contact the study team to confirm eligibility.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 29, 2022
Record last verified: 2022-04
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Source: ClinicalTrials.gov.
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