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390 active trials for Gastric Cancer

A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid Tumors

This is a Phase 1b/2, open-label, multicenter study of DSP-7888 Dosing Emulsion in combination with checkpoint inhibitors (nivolumab or pembrolizumab) in adult patients with solid tumors, that consists of 2 parts: dose search part of the study (Phase 1b) and the dose expansion part of the study (Phase 2). In Phase 1b of this study there will be 2 arms: Arm 1 and Arm 2. In Arm 1, there will be 6 to 12 patients who will be dosed with DSP-7888 Dosing Emulsion and nivolumab and in Arm 2 there will be 6 to 12 patients who will be dosed with DSP-7888 Dosing Emulsion and pembrolizumab. In addition, an enrichment cohort of a further 10 patients who have locally advanced or metastatic Renal Cell Carcinoma or Urothelial Cancer with primary or acquired resistance to previous checkpoint inhibitors will be enrolled into Phase 1b of the study to help evaluate the preliminary antitumor activity of DSP-7888 Dosing Emulsion at the safe dose level identified in the dose-search part of the study, and will be dosed with DSP-7888 Dosing Emulsion and nivolumab, or DSP-7888 Dosing Emulsion and pembrolizumab, as per the investigator's preference. Once the recommended dose is determined in Phase 1b, platinum-resistant ovarian cancer (PROC) patients will be enrolled in Phase 2 of the study with DSP-7888 Dosing Emulsion, exploring the combination with pembrolizumab (Arm 2). In Phase 2, approximately 40 patients with PROC will be initially enrolled. Approximately 80 patients in total will be enrolled in the study, if both groups in Phase 2 are enriched with an additional 20 patients. This brings the total maximum study population to approximately 104 patients. Patients in the enrichment cohort will not be replaced.

Start: December 2017
BLI for the Diagnosis of Precancerous Conditions and Cancerous Lesions

Introduction: At the present, conventional WLE (white light endoscopy) with biopsies according updated Sydney system is still considered the gold-standard for the diagnosis and stratification of gastric preneoplastic conditions. However, due to the high interobserver variability and the scarce correlation between the endoscopic and histopathological report, there is a growing use of virtual chromoendoscopy, which has shown excellent results on the diagnosis of these conditions. Numerous studies demonstrated the utility of NBI (Narrow Band Imaging) for this purpose, however, there is scarce data regarding the efficacy of the FUJIFILM system, Blue Light Imaging (BLI), on this topic, especially in Europe, despite the good results recently reported. Primary aim: to validate the new high-resolution endoscopic technologies with BLI on the diagnosis of gastric preneoplastic conditions. Material and methods: a multicentric cohort study will be performed involving centres from several European countries (Portugal, Spain, Italy, Belgium, Germany). Consecutive patients performing upper gastrointestinal (GI)endoscopy will be evaluated by WLE and BLI. Random biopsies or targeted plus random biopsies will be performed in order to determine de accuracy of BLI system to detect and stage gastric intestinal metaplasia (GIM). Expected results: We anticipate that BLI would enable us to assess the extension of GIM without the need for biopsies. If observed, this would overall improve the upper GI endoscopy accuracy.

Start: March 2021