View clinical trials related to Gastrointestinal Stromal Tumors.
Filter by:The R0 resection rate of gastrointestinal stromal tumor (GIST) with high recurrence risk was relatively low, and the relapse-free survival rate was relatively low, which needed to be further improved. A few retrospective analyses and a small sample of prospective studies have found that neoadjuvant therapy with imatinib mesylate can improve R0 resection rates. Whether neoadjuvant therapy prolongs long-term survival remains unclear. The primary objective of this study was to evaluate 5-year progression-free survival (PFS) for GIST patients with high recurrence risk after neoadjuvant treatment with imatinib mesylate.
GIST are rare mesenchymal tumors of the gastrointestinal tract characterized by somatic mutations in the gene encoding the KIT (85%) or the PDGFRα (8%) protein. Treatment of localized forms relies on adequate surgery without tumor spillage and sometimes systemic treatment with imatinib according to risk of relapse defined by localization, tumor size and mitotic count, as well as mutational status. More than 40% of cases may recur and metastasize. Advanced and relapsing forms are currently treated with oral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR such as imatinib (standard treatment), sunitinib (2nd line) and regorafenib (3rd line). Nevertheless, imatinib has little or no activity in patients harboring the D842V mutation in the exon 18 of PDGFRα (20% of gastric GIST, 6% of all GIST patients). Consequently, other therapeutic alternatives are needed. Results from the phase I single-arm NAVIGATOR study show that avapritinib has significant efficacy in GIST patients with PDGFRα D842V mutation (ORR = 86 %). In France, an authorization for temporary use (ATUc) starting on September 21st, 2020 has been granted by the National Agency for Safety of Medicines and Health Products (ANSM). It allows the early availability of avapritinib in France while waiting for Market Authorization Approval (AMM). This ATUc is now being followed by a post-ATU period. The objective of this real-life registry is to perform a long-term longitudinal follow up of PDGFRA D842V-mutated GIST patients and to collect effectiveness and safety data. It will be implemented in parallel to the post-ATUc period until June 2023. Moreover, this registry fulfills the HAS's ("Haute Autorité de Santé") request regarding the Establishment of an exhaustive registry of patients with GIST, harboring the D842V / PDGFRA mutation in France. This registry will specifically describe: - patient characteristics, in particular patient age, of the disease characteristics, previous treatments; - the clinical course; - the occurrence of adverse events / effects; - and the therapeutic strategy (endpoint of treatment or continuation). Data from the electronic health record (EHR) will be collected. Moreover, as per the ANSM's requirements, quality of life and cognitive function will be investigated using FACT-G, FACT-Cog and MoCA questionnaires. Undesirable effects will be collected as well. Follow-up is envisioned for a minimum of 2 years.
This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
The purpose of this study is to investigate the effect of multiple dosing of avapritinib on the pharmacokinetics (PK) of midazolam in adult patients with metastatic or unresectable gastrointestinal stromal tumors (GIST), recurrent gliomas, or other KIT mutant tumors.
Cognitive-behavioral therapy (CBT) has been found to be efficacious in the treatment of cancer-related cognitive impairment (CRCI). Memory and Attention Adaptation Training (MAAT) has been evaluated in previous clinical trials with samples of breast cancer survivors and found effective at reducing cancer-related cognitive impairment. MAAT has been demonstrated to be efficacious when it is delivered via videoconference.The use of telehealth delivery enhances access to cancer survivorship care and reduces time and travel burden among cancer survivors, especially those who live in rural and/or underserved areas where cancer survivor services are less available. People with a diagnosis of gastrointestinal stromal tumors also experience self-reported cancer-related cognitive impairment. In order to determine if MAAT can sufficiently treat CRCI among people with gastrointestinal stromal tumors (GIST), we propose a trial of MAAT to determine its initial level of effectiveness in improving both self-reported cognitive impairments and objective neuropsychological test performance in GIST patients.
This is an open-label extension study to provide long term safety data for GIST patients who are deriving clinical benefit from avapritinib upon the completion of avapritinib clinical trials.
Liver Transplantation for Unresectable GIST Liver Metastases
The genetic background for cancer treatment may also be different among different areas and races. There is lack of Taiwanese data of genetic alterations in cancer patients. To understand the landscape of genetic aberrations of cancer in Taiwan, large scale survey of the cancer patients is indicated. In this pilot study, the investigators want to evaluate the landscape of genetic aberrations in cancer patients via oncopaenl test and collect the clinical data of the patients. The result of the oncopanel test will be returned to patient and their attending physician for reference of their further treatment. In addition, the investigators want to correlate the clinical outcome with the genetic aberrations of the cancer patients in Taiwan. Gastrointestinal stromal tumor (GIST) is a rare cancer compared with the other solid tumors. C-KIT or PDGFRA mutation is found in approximately 85-90% of GISTs. Imatinib, a tyrosine kinase inhibitor targeting c-KIT, has been used to treat advanced GIST successfully since 2000. However, resistance to imatinib may develop either via secondary mutation of c-KIT or primary resistance to those with wild type c-KIT and PDGFRA. Although sunitinib and regorafenib have been approved as second and third line of treatment for advanced GIST, the progression free survival were only 6.8 and 4.8 months, respectively. The genetic landscape of GIST with wild type c-KIT and PDGFRA was less studied. In the current study, the investigators want to focus on the GISTs with wild type c-KIT and PDGFRA to perform the NGS oncopanel for these patients. Then the investigators can understand the genetic aberrations of these patients (wild type GIST) and help for searching the potential treatment targets to them.
The primary aim of this study is to collect clinical data on the performance of MonoPlus® suture applied in routine clinical practice. Diverse parameters are to be used to assess the safety and efficacy of MonoPlus® suture for gastrointestinal anastomosis construction. This study has been designed to implement an action within the framework of a proactive Post Market Clinical Follow up (PMCF) activity.
This research is a prospective, multi-center trial for endoscopic resection and laparoscopic partial gastrectomy in patients with 2-5cm gastric gastrointestinal stromal tumor. The primary purpose of this study is to evaluate the early operative morbidity and mortality and determine the safety of endoscopic resection compared with laparoscopic partial gastrectomy for 2-5cm gastric gastrointestinal stromal tumor. The second purpose is to evaluate the recovery course and compare the postoperative hospital stay of the patients enrolled in this study.