Li Shui Shi

Esophageal squamous cell carcinoma ESCC is a common and deadly cancer in China, with many patients diagnosed at advanced stages. This study evaluates a combined treatment approach using induction immunochemotherapy followed by concurrent chemoradiotherapy, aiming to improve outcomes for patients with locally advanced, unresectable ESCC. Researchers also focus on using circulating tumor DNA ctDNA to monitor treatment response and predict tumor progression, as ctDNA changes can appear before imaging detects recurrence. Participants receive induction immunochemotherapy consisting of toripalimab combined with paclitaxel and cisplatin every three weeks for two cycles. This is followed by radical concurrent chemoradiotherapy with weekly paclitaxel and cisplatin for five cycles along with radiotherapy delivered five days per week. The study dynamically monitors ctDNA levels at several points before treatment, before chemoradiotherapy, after 20 radiotherapy fractions, and every three months after treatment completion. During the study, participants undergo regular assessments including blood tests for ctDNA analysis and monitoring of tumor status. The main outcome measured is progression-free survival at one year. Safety and efficacy are tracked throughout the treatment and follow-up periods. The total participation duration and timing of assessments are carefully planned to evaluate the treatment strategy and its correlation with patient prognosis.

Researchers are evaluating the safety, tolerability, how the body processes and responds to the drug, and the anti-tumor activity of BGB-B2033 alone and in combination with tislelizumab, with or without bevacizumab. This first-in-human study focuses on participants with locally advanced or metastatic solid tumors including hepatocellular carcinoma, alpha-fetoprotein-producing gastric cancer, extragonadal yolk sac tumors, and glypican-3-positive squamous non-small cell lung cancer. The trial aims to determine safe dosage levels and preliminary effectiveness in these advanced cancer types. Participants receive intravenous infusions of BGB-B2033 either alone or combined with tislelizumab and bevacizumab in several dose escalation and expansion cohorts. The study includes ascending doses of BGB-B2033 monotherapy, combination therapies to find maximum tolerated doses and recommended doses for further testing, and safety expansion groups. Some participants are from Asian countries and others from the United States, focusing on hepatocellular carcinoma in these regions. Throughout the study, participants are closely monitored for adverse events and responses to treatment for up to approximately 2 years. Assessments include safety evaluations, measuring tumor responses by independent review and investigators, pharmacokinetic and pharmacodynamic tests, and antibody development against the study drug. Tumor tissue samples are required for certain parts of the study. This comprehensive follow-up helps researchers understand the study drugs activity and safety in advanced cancers.

Researchers are evaluating the safety and effects of a medicine called fosmanogepix for treating candidemia and invasive candidiasis, which are serious fungal infections caused by Candida yeast. This Phase 3 clinical trial compares fosmanogepix to the standard treatment using caspofungin followed by fluconazole, aiming to show that fosmanogepix is not worse than the standard treatment by a margin of 15%. The study includes adult patients diagnosed with these infections and is sponsored by Basilea Pharmaceutica. Participants are randomly assigned to one of two groups two-thirds receive fosmanogepix intravenously, with an option to switch to oral tablets, while one-third receive caspofungin intravenously followed by oral fluconazole. Matching placebos are given to maintain blinding. Treatments are given daily, first by IV infusion at the clinic and then orally either at the clinic or at home if discharged. Treatment duration can be up to six weeks, depending on infection clearance and symptom improvement. Participants will be monitored through multiple study visits, with assessments including survival status at 30 days, treatment success at the end of treatment, and follow-up evaluations six weeks after stopping treatment. Additional evaluations include clinical and mycological responses, blood cultures, safety monitoring such as adverse events, lab tests, neurological exams, ECGs, and drug concentration measurements. The total study duration for each participant may be approximately 12.5 weeks, considering treatment and follow-up periods.

Researchers are evaluating the safety and effectiveness of transarterial tirapazamine embolization TATE compared to conventional transarterial chemoembolization cTACE for patients with intermediate-stage hepatocellular carcinoma HCC, a type of liver cancer. This phase IIIII clinical trial aims to determine if TATE offers potential benefits over the current standard treatment, providing important insights for future care. The study is sponsored by Zhejiang Raygene Pharmaceuticals Co., Ltd and involves random assignment of participants to treatment groups. Participants will be randomly assigned to receive one of two treatments. The TATE group will receive a fixed dose of 35 mg tirapazamine injected into the artery feeding the tumor, followed by embolization using iodized oil, gelatin sponge, and contrast agent. The cTACE group will be treated with a mixture of iodized oil and 50 mg epirubicin, followed by embolization with gelatin sponge and contrast agent. Both treatments aim to block blood flow to the tumor and deliver therapy directly to the liver. The treatments are given as procedures involving catheter-based arterial injections. During the study, participants will be monitored for up to 36 months to assess progression-free survival as the primary outcome. Secondary outcomes include complete response rate, objective response rate, duration of complete response, and overall survival. Researchers will perform regular evaluations to track tumor response and patient health. Safety and treatment effects will be closely observed throughout the study period, ensuring participant well-being and thorough data collection.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Researchers are evaluating the safety and effectiveness of rilvegostomig combined with gemcitabine plus cisplatin compared to durvalumab combined with gemcitabine plus cisplatin as a first-line treatment for patients with advanced biliary tract cancer BTC. This phase III, randomized, open-label study aims to improve treatment options for patients with unresectable locally advanced or metastatic BTC who have not received prior therapy for advanced disease. The study focuses on overall survival and other important outcomes over approximately four years. Participants receive either rilvegostomig or durvalumab through intravenous infusion along with chemotherapy drugs gemcitabine and cisplatin. Durvalumab is given every three weeks for up to eight cycles, then every four weeks. Gemcitabine and cisplatin are administered intravenously on Days 1 and 8 of each 21-day cycle. The study compares these two treatment combinations to assess their effects on survival, disease progression, tumor response, and safety. During the study, participants undergo regular assessments including imaging scans like CT or MRI to measure disease status, laboratory tests to evaluate organ function, and evaluations of symptoms and quality of life. Researchers monitor drug levels and immune response markers. The study lasts about four years, with ongoing safety and health status monitoring throughout. Patient-reported symptoms and quality of life are assessed up to 12 weeks after disease progression.

Researchers are investigating the changes in various factors such as cell growth factors, inflammatory markers, metabolites, and plasma proteins in the blood of patients with Acute Coronary Syndrome ACS. The study aims to understand how these changes relate to disease prognosis by comparing the ACS group with those having Chronic Coronary Syndrome CCS and a control group without coronary artery or structural heart diseases. Blood samples will be collected within 24 hours of hospital admission to analyze these factors using multi-omics and related research methods. Participants will be categorized into three groups those with ACS, those with CCS, and a control group without heart disease. Blood samples will be taken promptly after hospital admission to measure levels of fibroblast growth factors, inflammatory cytokines, chemokines, cytochrome C, mitochondrial DNA, and malondialdehyde. The study will also examine the relationships between these markers and clinical indicators such as troponin I, brain natriuretic peptide, lactate dehydrogenase, and left ventricular ejection fraction. During the study, participants will undergo peripheral venous blood collection within 24 hours of admission. Researchers will monitor and analyze various blood markers to evaluate their association with heart disease status and prognosis. The studys main outcomes focus on changes in specific circulating factors and their correlation with heart function measures, helping to better understand the biological processes in ACS and CCS. Participation duration depends on hospital admission timing and sample collection.

People with end stage kidney disease ESKD who require dialysis face a much higher risk of cardiovascular disease compared to the general population, with cardiac issues causing 58% of deaths in this group. However, while aspirin is known to reduce cardiovascular problems in the general population, there is limited evidence about its effects in dialysis patients. The ASPIrin to Reduce Event in Dialysis ASPIRED trial aims to study whether taking low-dose aspirin can safely improve cardiovascular outcomes in people with ESKD receiving dialysis. This study is a multi-center, double-blind, randomized controlled trial that will compare daily low-dose aspirin 100 mg to a placebo pill in patients undergoing dialysis. The trial uses an existing dialysis registry platform to screen, recruit, and collect data during routine clinical care, minimizing participant burden and study costs. Randomization is managed through a secure web-based system, and follow-up visits occur every six months as part of regular clinic visits. The trial is expected to last approximately five years and includes oversight by an independent safety and monitoring board. Participants will be involved in regular six-monthly clinic visits where their health will be monitored as part of their usual dialysis care. Researchers will track the occurrence of major cardiovascular events, including heart attacks, strokes, vascular complications, and deaths, throughout the study period. Data will be collected from routine clinical procedures and the dialysis registry to evaluate outcomes. Safety and efficacy will be closely monitored, and the study will follow participants for up to five years to assess the long-term effects of aspirin use in this population.