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Those patients will be enrolled in a newly diagnosed metastatic pancreatic cancer tumor carcinoma in both sexes, aged 18 to 85 years, will be treated with standard first-line chemotherapy. Patients will receive 20 mg bazedoxifene orally per day, subject to good clinical tolerance and in the absence of a biological contraindication. Patients will be able to get bazedoxifene every day, with or without meals. For the duration of the bazedoxifene intake, prophylactic rivaroxaban 10 mg orally once a day will be added to reduce the risk of thromboembolic events. Pantoprazole 20 mg once per day will be administered in selected patients to reduce gastric problems, according to the physician's appreciation. Participants will be provided with bazedoxifene and rivaroxaban for the entire study duration from a subinvestigator during the treatment initiation visit. At this point, the EORTC core quality of life questionnaire, as well as the health of life questionnaire, will be evaluated. In addition, the IL-6 pathway's activity will be assessed immunohistochemically on metastasis biopsy prior to the administration of bazedoxifene. A biopsy done before study participation can be used as a baseline to prevent a second biopsy. Plasma samples will be collected before and after storage and samples will be analyzed by next generation sequencing NGS. The effect of bazedoxifene on inflammatory pathways and tumor progression will be determined by comparing the change in the expression of the IL-6 pathway from baseline will be evaluated.
Source link: https://clinicaltrials.gov/ct2/show/NCT04812808
Myeloid suppressor cells in the PDAC TME, while suppressed by a prolific expression of Semaphorin 4D receptors, Plexin B1 and Plexin B2, are evidently. Semaphorin 4D blockade, on the other hand, represents a new immunotherapeutic tactic within the PDAC TME. Once 16 patients have adapted to a particular dose based on the BOIN design, the MTD dose is introduced as the dose yielding 30% or lower DLT rate. According to Simon's two-stage research, the trial will commence when there are 1 or less objective responses among these 16 patients, but if there are 1 or less objective responses, the trial will be suspended early for efficacy futility, according to Simon's two-stage study. 1,2 If after an initial assessment of futility, the trial will begin. As the MTD dose prescribed by Phase 1b, escalation will stop, and all patients will then enter the second stage of the trial at the MTD dose determined by Phase 1b. When incorporating the 16 patients from Phase 1b, the Phase 2 cohort will have an evaluable sample size of 40. The true response rate is 0. 10 or less, according to the null hypothesis, and the alternative assumption is that the real response rate is 0. 23 or higher.
Source link: https://clinicaltrials.gov/ct2/show/NCT05102721
Given the promising early clinical findings, GCN is expected to be the front-line therapy for biliary and pancreatic cancer in the future. Investigators hypothesize that a TTF+G maintenance program will take a cutting edge approach and may possibly rewrite the front-line standard of care therapy in patients with stage IV pancreatic cancer.
Source link: https://clinicaltrials.gov/ct2/show/NCT04605913
ASP2138 is a potential new therapy for people with stomach cancer, gastroesophageal junction cancer, or pancreatic cancer. This means that people in this research will know that they will get ASP2138. Dose escalation has been described as part of Phase 1 of dose escalation. Different small groups of people may be able to lower doses of ASP2138. Doctors will also see how each form of cancer is responding to ASP2138. Dose expansion is measured on Phase 1b. This phase will determine how each type of cancer responds to ASP2138. People will continue to receive care until: their disease becomes more severe; they have medical problems they can't cope with; they have medical conditions they can't accept; they request to stop therapy; the doctors find that continuing treatment is not in the patient's best interest; the study is concluded by the sponsor. Study doctors will examine any medical conditions from ASP2138. In a hospital, people will be given ASP2138. They will request blood samples and diagnostic specialists will look for medical issues. People will also visit the clinic on certain days during their treatment, with extra visits during the first three cycles of therapy. Patients will return to the hospital after the surgery has concluded. The research doctors will investigate further medical issues. People will return to the clinic for a check-up several times after this. The number of visits and checks done at each visit will vary depending on the individual's health and whether they started or not during their procedure.
Source link: https://clinicaltrials.gov/ct2/show/NCT05365581
Metastatic Pancreatic Cancer Disease is one of the most aggressive and fatal forms of cancer with very poor longevity. In this study, doctors will enroll patients aged 18 to 75 years of age with a body mass greater than or equal to 35 kilograms diagnosed with Metastatic Pancreatic Cancer Disease in four separate groups, which are designated as treatment arms. On day 1 and Day 15 of every 28 day cycle, participants will be able to receive ABBV-927 and Budigalimab as Intravenous Infusion in Phase 1b and Phase 2 of every 28-day cycle, as Intravenous Infusion in Phase 1b and Phase 2 of every 28-day cycle, with IV Infusion in Phase 1b and Phase 2 from the maximum of two years.
Source link: https://clinicaltrials.gov/ct2/show/NCT04807972
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