Shao Guan Shi

Researchers are evaluating the preliminary safety and effectiveness of AL8326 tablets combined with Toripalimab in patients who have advanced recurrent or metastatic solid tumors. This open, non-randomized phase IIIa trial aims to find the recommended phase II dose and assess objective remission rates among these patients who have limited treatment options or have experienced progression after standard therapies. The study has two parts Phase 1 involves sequential cohorts receiving AL8326 plus Toripalimab 240 mg in 28-day cycles, with dose escalation based on tolerance. Phase 2a continues treatment with AL8326 administered orally daily at the recommended dose alongside Toripalimab 240 mg given in 21-day cycles. Treatment cycles continue for up to 24 months or until disease progression or unacceptable toxicity. Participants will undergo regular assessments including tumor response evaluations every 2 to 4 cycles depending on the phase, along with safety monitoring and laboratory tests. Outcomes measured include remission rates, duration of remission, disease control, progression-free survival, and overall survival. The study requires participants to comply with follow-up procedures and safety evaluations throughout the treatment and observation periods.

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 studying a new mucosal contouring method to predict radiation-induced oropharyngeal mucositis in patients with nasopharyngeal carcinoma NPC. This condition, which causes swallowing-induced breakthrough pain, greatly affects patients quality of life during radiotherapy. Previous prediction models using oral cavity or mucosa surface contouring were not satisfactory, so this study aims to further evaluate a method based on mucosal areas linked to breakthrough pain in a real-world, multicenter observational setting. This observational study will follow patients with locally advanced NPC undergoing radical radiotherapy or chemoradiotherapy. The study focuses on assessing how well the mucosal delineation method predicts the occurrence and severity of oropharyngeal mucositis by tracking swallowing-induced breakthrough pain. There are no investigational treatments involved instead, patients are observed and data is collected during their standard care. Participants will have their oral or oropharyngeal mucositis severity and swallowing pain recorded continuously throughout their treatment. Researchers will analyze the predictive models performance by measuring accuracy, sensitivity, specificity, and other statistical values over up to three years. The study will help improve risk assessment and early intervention for mucositis in NPC patients, with all data collected during their regular clinical visits.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating the use of pegmolesatide, a long-acting erythropoiesis-stimulating agent ESA, in patients with renal anemia who are currently treated with hypoxia-inducible factor prolyl hydroxylase inhibitors HIF-PHIs. This trial aims to explore the safety and effectiveness of switching from HIF-PHIs to pegmolesatide, addressing the current need for longer-acting and safe medications. The study is a multi-center, prospective, open-label, randomized parallel-controlled trial enrolling 96 dialysis chronic kidney disease patients with anemia. Participants are divided into two groups based on their current weekly Roxadustat dose a low-dose cohort 210 mg and a high-dose cohort >210 mg and 360 mg. Within each cohort, patients are randomly assigned to receive pegmolesatide at different initial doses 2 mg, 4 mg, or 6 mg administered subcutaneously once every 4 weeks. The dose may be adjusted according to the drugs instructions. The treatment period lasts 12 weeks, followed by a 16-week follow-up period. During the study, researchers will monitor hemoglobin levels and other blood parameters at various intervals to assess the effects of pegmolesatide. Patients will undergo assessments including hemoglobin tests, red blood cell counts, and safety monitoring for adverse events. The primary measurement is the change in mean hemoglobin levels from baseline to 12 and 16 weeks. The total participation time for each patient is 28 weeks, including treatment and follow-up.

Researchers are evaluating the safety, effectiveness, and how the body processes a drug called YL201 when combined with Toripalimab, either with or without Cisplatin, in adults with recurrent or metastatic nasopharyngeal carcinoma. This open-label Phase IbII trial is conducted across multiple centers in China and focuses on patients whose cancer cannot be cured with local treatment. The study aims to better understand treatment effects in this advanced cancer setting. Treatment involves two groups one receiving YL201 plus Toripalimab and another receiving YL201 plus Toripalimab and Cisplatin. All study drugs are given by intravenous infusion. The trial includes a dose exploration phase to assess safety and efficacy of these combinations. Participants receive treatment according to randomized assignment to one of these regimens. Participants will be monitored for side effects, cancer progression, and response to treatment over about 36 months. Researchers will assess dose-limiting toxicities, treatment-emergent adverse events, progression-free survival, and other measures such as response rate and overall survival. The study also evaluates how YL201 and its metabolites behave in the body. Participants will undergo regular medical exams, imaging, and lab tests during the study period to track outcomes and safety.

Researchers are evaluating the efficacy and safety of tulisokibart in participants with moderately to severely active Crohns disease. This program includes two studies Study 1 involves both induction and maintenance treatment phases, while Study 2 focuses only on induction treatment. The main goal is to determine if one or more doses of tulisokibart are more effective than placebo in achieving clinical remission and endoscopic response at various time points up to Week 52. Participants are randomly assigned to receive different dosing regimens of tulisokibart or placebo. These regimens include high or low doses administered intravenously followed by subcutaneous injections, or subcutaneous injections alone. Some participants may continue in an extension phase receiving subcutaneous doses after completing their original treatment arm if they meet specific requirements. The studies use a double-blind design to compare tulisokibarts effects against placebo. During the trial, participants undergo regular assessments to measure clinical remission, endoscopic response, and other health outcomes using tools like the Crohns Disease Activity Index and stool frequency with abdominal pain scores. Safety evaluations include monitoring adverse events and treatment discontinuations. The studies last up to 52 weeks for Study 1 and 12 weeks for Study 2, with multiple visits to assess treatment effects and participant health under medical supervision.

This trial is for adults who have had an acute ischemic stroke caused by a blood clot blocking a brain vessel. It focuses on people whose stroke occurred or was discovered more than 4.5 hours ago, including those who woke up with stroke symptoms. The study aims to find out if the medicine tenecteplase helps recovery when given after this 4.5-hour window, compared to standard medical care. Tenecteplase is already used within 4.5 hours after stroke onset, but this study tests its effect when given later. Participants are randomly assigned to one of two groups one receives a single injection of tenecteplase into a vein, and the other receives the usual standard treatment. Both groups have an equal chance of receiving either treatment. The study lasts about three months, starting with approximately one week of hospital stay. During the study, participants have seven clinical examinations or visits, with the final two visits conducted remotely from home to allow for easier participation. Throughout the study, doctors regularly assess participants recovery using a scale that measures disability and dependence in daily activities. They also monitor overall health and record any side effects. The main outcome measured is the level of recovery 90 days after treatment, comparing the two groups. This includes neurological improvement, bleeding events, and survival over the study period.

Researchers are evaluating adjuvant chemotherapy for patients with stage III gastric cancer who have undergone D2 gastrectomy and achieved R0 resection. This phase 3, open-label, randomized study compares the effects of oxaliplatin plus S-1 versus docetaxel plus S-1 on disease-free survival. The study aims to provide direct comparison of these two chemotherapy regimens, focusing on their safety profiles, treatment duration, and patient adherence. Participants are randomly assigned to one of two treatment groups. The first group receives eight 3-week cycles of intravenous oxaliplatin with oral S-1 doses adjusted by body surface area. The second group receives oral S-1 for the first cycle, followed by six cycles of intravenous docetaxel plus oral S-1, and then continues oral S-1 for up to one year. The treatments are given after surgery, and the study includes follow-up for five years. During the study, participants undergo monitoring for disease recurrence and overall survival, along with safety assessments over approximately six months of treatment. The main outcome measured is the 3-year disease-free survival rate, with secondary outcomes including 5-year overall survival, safety profiles, and recurrence sites. The study will track patients closely with regular evaluations throughout the treatment and follow-up periods.

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.