Shanwei

Researchers are evaluating how well nipocalimab works compared to a placebo in adults with moderate to severe systemic lupus erythematosus (SLE), a chronic disease where the immune system attacks healthy tissues causing swelling and redness in various organs. This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study focused on adults aged 18 to 75 who have active SLE symptoms and have been diagnosed for at least 24 weeks. Participants will receive either nipocalimab or a placebo alongside standard of care treatments, which include protocol-defined topical and systemic therapies. Nipocalimab and placebo are administered as drugs while maintaining background treatments. The study monitors participants over time, including a primary outcome measurement at Week 52 to assess the percentage of participants achieving a systemic lupus erythematosus responder index (SRI)-4 composite response. During the study, participants will be regularly assessed for disease activity, vital signs, and safety. Screening includes physical examinations, medical history review, vital signs, and electrocardiograms. Researchers will monitor disease activity scores and evaluate response to the treatment at Week 52. Safety is closely observed throughout the study, with particular attention to any adverse reactions or changes in health status. The total participation and follow-up extend at least through Week 52.

People with end stage kidney disease (ESKD) who require dialysis have a much higher risk of developing cardiovascular disease compared to the general population, with heart problems causing over half of the deaths in this group. This trial is studying whether taking low dose aspirin daily can safely reduce cardiovascular events in these dialysis patients. The study is a Phase 4, multi-center, randomized controlled trial designed to provide clear evidence about aspirin's benefits and risks in this specific population, where existing data is limited. Participants will be randomly assigned to receive either a daily 100 mg aspirin tablet or a matching placebo. The trial uses the Chinese peritoneal dialysis and hemodialysis registry to efficiently screen and recruit patients and collect data during routine dialysis care. Follow-up visits occur every six months as part of regular clinical care, and the study will continue until enough cardiovascular events have occurred, expected to take about five years. During the study, participants will have their health monitored through routine clinic visits every six months, with data collected on cardiovascular events and safety. The main outcome measured is the number of participants experiencing major cardiovascular events over the study period. An independent board will oversee safety and study progress. The trial uses intention-to-treat analysis and aims to minimize participant burden by integrating study procedures into usual care.

Researchers are studying the progression and timing of mild Non-Lactational Granulomatous Lobular / Periductal Mastitis (NL-GLM/PDM), an inflammatory breast condition characterized by breast masses. This observational study aims to understand how often and when disease progression occurs in patients managed with an observation-only approach. It also seeks to identify clinical and pathological factors linked to disease progression in these patients. Participants will be observed without receiving treatments known to be effective for NL-GLM/PDM, such as surgery, corticosteroids, antibiotics, or ductal lavage. Symptomatic pain management with NSAIDs and routine wound care for fistulas or skin lesions are allowed. The study is designed as a single-center, single-arm, prospective cohort to monitor participants over time without active treatment unless disease progression occurs. During the study, participants will be regularly monitored to collect data on clinical outcomes and factors influencing disease progression. Researchers will assess how many participants remain free of disease progression and treatment at 12 weeks after enrollment. The findings will help guide future clinical practice and research strategies for managing mild NL-GLM/PDM.

Researchers are investigating the safety and effectiveness of combining Inetetamab with either Pertuzumab or Pyrotinib plus chemotherapy as a first-line treatment for women with HER2 positive recurrent or metastatic breast cancer. This study aims to provide improved clinical outcomes and develop a new targeted treatment approach for this condition. It focuses on patients with invasive breast cancer confirmed to be HER2 positive, who have not received prior first-line anti-HER2 therapy or have discontinued effective adjuvant treatment for more than 12 months. Participants are divided into two groups: Group A receives Inetetamab combined with Pertuzumab and chemotherapy, while Group B receives Inetetamab combined with Pyrotinib and chemotherapy. Inetetamab and Pertuzumab target different extracellular domains of the HER2 protein to block its activity, whereas Pyrotinib works inside cells to prevent HER2 activation. The combination treatments aim to enhance anti-HER2 effects by dual targeting HER2 pathways. Participants will undergo tumor assessments every six weeks from the start of the study until disease progression or death, for up to two years. Researchers will monitor overall response rate as the primary outcome. Throughout the study, patients will have regular evaluations including imaging scans, blood tests, heart function tests, and physical assessments to ensure safety and track treatment effects. The study includes ongoing follow-up to monitor participant health and treatment responses over time.