Baiyin

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.

Researchers are evaluating a new chemotherapy drug called JSKN003 in people with recurrent or metastatic breast cancer that is HER2-low and cannot be removed by surgery. This phase III clinical trial compares JSKN003 to chemotherapy drugs chosen by doctors in patients who have already tried and not responded to one or two previous chemotherapy treatments. The study aims to assess the safety and effectiveness of JSKN003 in this group of patients. Participants are randomly assigned to one of two groups one group receives JSKN003 alone given by intravenous infusion, while the other group receives one chemotherapy drug selected by their doctor from options like capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin. The choice of the chemotherapy drug for the control group is made before randomization. Treatment schedules follow the study protocol at multiple centers. During the study, participants will have regular assessments including scans to measure tumor progression and other tests to evaluate response and overall survival, monitored for up to about three years after enrollment. Researchers will track progression-free survival as the main outcome, along with overall survival, response rate, and duration of response. Safety and side effects will also be closely monitored throughout the study.

Researchers are evaluating the clinical outcomes and characteristics of adult patients in China with resected stage II to IIIB anaplastic lymphoma kinase ALK-positive non-small-cell lung cancer NSCLC who have been treated with Alectinib as adjuvant therapy. This multicenter, prospective cohort study aims to observe these patients in real-world clinical practice settings to better understand their disease progression and response to treatment. Participants in this observational study have already received Alectinib monotherapy as adjuvant therapy following complete surgical resection of their NSCLC. No additional intervention is provided by the study. Patients are followed for approximately 2.5 years during routine clinical visits to monitor their health status and treatment outcomes. During the study, participants will have periodic assessments including evaluations of disease-free survival, treatment duration, clinical characteristics, and quality of life using the 36-item short form survey SF-36 every three months. Researchers will also monitor adverse events from the time of enrollment until 28 days after the last dose of Alectinib or withdrawal from the study. The total follow-up period is up to approximately 2.5 years.

Researchers are studying Rina-S, a drug designed to target folate receptor alpha, in people with advanced solid tumors that have either spread or cannot be removed by surgery. This Phase 12 trial aims to evaluate the safety, how the drug behaves in the body, and its antitumor activity. The study includes several parts focusing on specific cancers such as ovarian, endometrial, breast, lung cancers, mesothelioma, and cervical cancer, reflecting different patient groups and treatment approaches. Participants may receive Rina-S alone or combined with other drugs like carboplatin, bevacizumab, or pembrolizumab. Treatment continues until disease progression, unacceptable side effects, or other reasons such as withdrawal or study end. The study involves multiple cohorts, including those with platinum-resistant or platinum-sensitive ovarian cancer and endometrial cancer, with dosing and combination therapies tailored to these groups. During the trial, participants undergo regular assessments including imaging scans evaluated by standardized criteria, safety monitoring for side effects, and blood tests to study drug levels and immune responses. Outcomes measured include treatment side effects, tumor response rates, progression-free and overall survival, and pharmacokinetics. Participants may be followed for up to approximately two years to evaluate long-term effects and treatment responses.

Researchers are evaluating the safety and effectiveness of combining Zorifertinib with Osimertinib for people who have advanced Non-Small Cell Lung Cancer NSCLC that has spread to the membranes around the brain and spinal cord, known as leptomeningeal metastases. This study focuses on patients who have already been treated with Osimertinib but experienced progression in the meningeal area. The trial is a Phase 1 study designed to find the recommended dose and further assess safety and treatment response. All participants will receive both Zorifertinib and Osimertinib. Zorifertinib is given orally twice daily at increasing doses starting at 100 mg, while Osimertinib is taken once daily at a fixed dose of 80 mg. The study has two parts Part A involves dose escalation to identify the best dose for further use, and Part B expands the number of participants receiving the recommended dose to evaluate safety, effectiveness, and how the body processes the drugs. Treatment continues until the cancer worsens, side effects become unacceptable, or other stopping criteria are met. Participants will be monitored through regular assessments including neurological exams, brain and spinal imaging, and cerebrospinal fluid tests. Researchers will measure dose-limiting toxicities during the first 21 days, track adverse events and serious side effects for up to 12 months, and evaluate tumor responses using standardized criteria. Outcomes such as progression-free survival, response rates in the brain and overall tumors, and changes in neurological function will be closely followed. The study may last until September 2028, with safety and effectiveness data collected throughout treatment.