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GIST clinical trials

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NCT ID: NCT06208748 Not yet recruiting - Clinical trials for Gastrointestinal Stromal Tumors

SARC044: A Phase II Trial of Bezuclastinib in Combination With Sunitinib in Patients With GIST

Start date: March 2024
Phase: Phase 2
Study type: Interventional

This is an open label, single arm, phase 2 trial investigating bezuclastinib plus sunitinib in patients with GIST who have previously progressed on sunitinib.

NCT ID: NCT05957367 Recruiting - Colorectal Cancer Clinical Trials

A Study of DCC-3116 in Combination With Anticancer Therapies in Participants With Advanced Malignancies

Start date: September 28, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, multicenter, open-label (unless otherwise specified in a combination-specific module) study of DCC-3116 in combination with anticancer therapies. Modules within the master protocol are defined according to different combinations of DCC-3116 with other anticancer agents.

NCT ID: NCT05895942 Recruiting - GIST Clinical Trials

Exploring the Molecular Mechanism Based on KIT Mutation

EMMBKM
Start date: September 10, 2021
Phase:
Study type: Observational [Patient Registry]

Imatinib remains suboptimal for recurrence/metastasis and unresectable GIST response rates. With the maturity of genomics and metabolomics, people gradually realize the role of gut microbiota in tumor therapy. The gut microbiota may affect tumor treatment by regulating the tumor microenvironment or the host immune system, and some bacteria can fight tumors by activating the immune system. Growing evidence shows that the effect of tumor therapy is related to the composition of the gut microbiota of patients, and that the composition of the gut microbiota of patients sensitive to drug treatment has certain characteristics, and these characteristics may be used as biomarkers to predict the prognosis of treatment. At present, it remains unclear whether the efficacy of imatinib is related to the gut microbiota in GIST patients. Therefore, precise mining of microbial information and the development of reasonable and feasible microbial interventions are expected to optimize the treatment strategy of GIST to a large extent and provide a basis for individualized treatment of advanced GIST.

NCT ID: NCT05804331 Recruiting - Gastric Cancer Clinical Trials

The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study

ANZ UGI
Start date: March 14, 2023
Phase:
Study type: Observational [Patient Registry]

To determine the long term outcomes of Endoscopic Submucosal Dissection (ESD), Endoscopic Full Thickness Resection (EFTR) and Submucosal-Tunnelling Endoscopic Resection (STER) for upper gastrointestinal neoplastic lesions

NCT ID: NCT05734105 Recruiting - GIST Clinical Trials

A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib

INSIGHT
Start date: December 13, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase 3, 2-arm, randomized, open-label, global, multicenter study comparing the efficacy of ripretinib to sunitinib in participants with GIST who progressed on first-line treatment with imatinib, harbor co-occurring KIT exons 11+17/18 mutations, and are without KIT exon 9, 13, or 14 mutations. Upon disease progression as determined by an independent radiologic review, participants randomized to sunitinib will be given the option to either crossover to receive ripretinib 150 mg QD or discontinue sunitinib.

NCT ID: NCT05641233 Recruiting - Pancreatic Fistula Clinical Trials

Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy

FIBROPANC-1
Start date: December 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The FIBROPANC-1 investigates the feasibility and safety of preoperative stereotactic radiotherapy of 4cm pancreas in patients undergoing pancreatoduodenectomy at high risk (>25%) of developing post operative pancreatic fistula (POPF). A single course of 12Gy preoperative radiotherapy may lead to sufficient fibrosis in a small (4cm) targeted area, thereby reducing the risk of grade B and C POPF.

NCT ID: NCT05474794 Recruiting - Leiomyoma Clinical Trials

Detective Flow Imaging Endoscopic Ultrasonography in Subepithelial Lesions

Start date: July 20, 2022
Phase: N/A
Study type: Interventional

Gastrointestinal stromal tumors (GIST) are the most common malignant subepithelial lesions (SELs) found in the gastrointestinal tract. The diagnosis and differentiation of these lesions from other subepithelial hypoechogenic tumors (i.e.as leiomyoma), is important as this may have an impact in the prognosis and treatment of either. Due to GIST's notable features (vascularity and deep location), endoscopic ultrasound (EUS) is the first-line diagnostic approach. Based on this, three models (color-doppler EUS, power-doppler EUS, and e-FLOW EUS), are useful for real-time vascularity detection; however, these modalities are not helpful for fine and slow flow vessel detection. For overcoming this limitation, contrast-enhanced EUS (CE-EUS) is proposed as a first-line approach. Nevertheless, the use of contrast may be harmful, thus limited to some patients. To avoid contrast-related adverse events, a novel diagnostic method known as detective flow imaging endoscopic ultrasonography (DFI-EUS) has emerged. This technique detects fine vessels and slow flow without contrast. Despite the advantages of the latter, few studies have compared it with other diagnostic approaches in the evaluation and differentiation of SELs. Hence, the investigators aim to evaluate the utility of DFI-EUS in the diagnosis of SELs (GIST and leiomyoma) by comparing it with CE-EUS.

NCT ID: NCT05443087 Recruiting - Clinical trials for Hepatocellular Carcinoma

TARGETed Therapy Drug MONITOring in DIGestive Oncology

TARGETMONITO
Start date: August 29, 2022
Phase: N/A
Study type: Interventional

Targeted therapy drug monitoring in digestive oncology: Dosage of plasma levels of various multikinase inhibitors (MKI) in patients treated for advanced digestive cancer (gastrointestinal stromal tumor (GIST), metastatic colorectal cancer (mCRC), hepatocellular carcinoma (HCC), gastroenteropancreatic neuroendocrine tumor (gepNET), or pancreatic neuroendocrine tumor (pNET)), with the aim of determine the optimal dose adapted for each patient, in the future.

NCT ID: NCT05400018 Completed - Clinical trials for Gastrointestinal Stromal Tumors

Clinical Evaluation of Genetron D842V PCR Kit in GIST Patients

Start date: November 20, 2020
Phase:
Study type: Observational

The purpose of this trail is to evaluate the performance of Genetron D842V PCR kit in GIST patients using real-time PCR method.

NCT ID: NCT04927260 Active, not recruiting - GIST Clinical Trials

French Long Term Registry With Longitudinal Follow up of PDGFRA D842V-GIST Patients

AVIATOR2020
Start date: March 31, 2021
Phase:
Study type: Observational [Patient Registry]

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.