Shao Guan Shi

Researchers are evaluating the safety and early effectiveness of AL8326 tablets combined with Toripalimab in patients with advanced recurrent or metastatic solid tumors. This open, non-randomized Phase I/IIa clinical trial focuses on patients who have failed standard therapies or for whom no effective treatment is available, including those receiving Toripalimab as a second-line or later treatment. The study aims to determine the recommended dose and assess tumor response over time. Participants will receive AL8326 tablets orally once daily at a dose of 10 mg per tablet, alongside Toripalimab administered by injection every 21 days at 240 mg per cycle. The trial includes a Phase I portion to identify the recommended dose after the first 28-day cycle, followed by a Phase IIa segment that monitors objective remission rates every 2 to 4 cycles, continuing for up to 24 months. Treatment schedules and dosages are carefully managed to evaluate combined therapy effects. During the study, participants will undergo regular medical assessments, including tumor measurements using RECIST 1.1 criteria and safety evaluations such as blood tests, heart function tests, and monitoring of side effects. Researchers will track the participants' response to treatment, life expectancy, organ function, and overall health status. Follow-up procedures ensure safety and effectiveness are continually monitored throughout the treatment period and beyond.

Radiation-induced oropharyngeal mucositis, which causes swallowing-induced breakthrough pain, is a common and challenging side effect for patients with nasopharyngeal carcinoma (NPC) undergoing radiotherapy. Existing predictive models using oral cavity or mucosa surface contouring methods have shown unsatisfactory results in predicting the occurrence and severity of this condition. To address this, researchers are evaluating a mucosal delineation method based on areas causing swallowing-induced breakthrough pain, which preliminary results suggest may predict radiation-induced oropharyngeal mucositis more effectively in locally advanced NPC. This research is a prospective, multicenter, real-world observational study aimed at further assessing the predictive accuracy of this new mucosal contouring method. Participants are patients with NPC undergoing radical radiotherapy or chemoradiotherapy. The study follows these patients throughout their treatment, collecting complete and continuous records of oral and oropharyngeal mucositis grading, as well as self-reported swallowing-induced breakthrough pain. During the study, researchers monitor participants up to three years to evaluate the performance of the predictive model using the area under the curve (AUC) measurement. Data collection includes clinical assessments of mucositis severity and detailed pain reports to understand the link between radiation dose, mucosal injury, and breakthrough pain. This long-term observation aims to improve risk assessment and early intervention for radiation-induced oropharyngeal mucositis, potentially enhancing treatment outcomes and patient quality of life.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating pegmolesatide, a long-acting erythropoiesis-stimulating agent (ESA), in patients with renal anemia who are undergoing dialysis and have been treated with hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs). Pegmolesatide was recently approved by the National Medical Products Administration in June 2023. While previous studies showed its safety and effectiveness in dialysis patients previously treated with recombinant human erythropoietin, this trial aims to assess the safety and efficacy of switching from HIF-PHIs to pegmolesatide, as well as to establish dose conversion standards. The study is a multi-center, prospective, open-label, randomized parallel-controlled clinical trial enrolling 96 patients. Participants are divided into low-dose and high-dose Roxadustat cohorts based on their prior weekly Roxadustat dose. Each cohort is further split by hemoglobin levels and then randomized to receive different initial doses of pegmolesatide (2 mg, 4 mg, or 6 mg) administered subcutaneously every four weeks. Treatment lasts for 12 weeks, followed by a 16-week follow-up period. During the study, patients receive regular doses of pegmolesatide with dose adjustments as needed per drug instructions. Researchers will monitor hemoglobin levels from baseline to 12 and 16 weeks to evaluate treatment effects. Throughout the trial, patients undergo assessments to ensure safety and treatment adherence, with overall involvement lasting 28 weeks from the start of treatment to the end of follow-up.

This is a multicenter, open-label, Phase Ib/II study conducted in China to evaluate the safety, efficacy, and pharmacokinetic (PK) characteristics of YL201 combined with Toripalimab (doublet regimen) or YL201 combined with Toripalimab and Cisplatin (triplet regimen) in subjects with recurrent or metastatic nasopharyngeal carcinoma.

Researchers are evaluating the safety and effectiveness of tulisokibart, a humanized monoclonal antibody, in people with moderately to severely active Crohn's disease. The research includes two studies: Study 1, which has induction and maintenance treatment phases, and Study 2, which only includes induction treatment. The main goals are to see if tulisokibart can help participants achieve clinical remission and endoscopic response compared to placebo, measured at 12 and 52 weeks depending on the study and region (US/FDA or EU/EMA).

Researchers are evaluating the effect on disease-free survival of two adjuvant chemotherapy regimens after D2 gastrectomy in patients with stage III gastric cancer. This phase 3, multicenter, open-label, randomized, non-inferiority study compares oxaliplatin plus S-1 (SOX) with docetaxel plus S-1 (DS) to assess which treatment provides better disease control. Both regimens are currently recommended based on previous trials, but their efficacy and safety have not been directly compared in the same study population before. Patients will be randomly assigned to receive either the SOX regimen, consisting of eight 3-week cycles of intravenous oxaliplatin with oral S-1 dosed by body surface area, or the DS regimen, which includes S-1 for the first cycle, followed by six cycles of intravenous docetaxel plus S-1, and then continuation of S-1 alone for up to one year. The treatment schedules differ in duration and drug administration methods, with oxaliplatin-related side effects and prolonged treatment periods considered important factors. During the study, participants will be followed for 5 years after surgery to monitor outcomes. Researchers will assess disease-free survival over 3 years from randomization as the primary outcome. The study includes careful monitoring of organ function, treatment adherence, and adverse effects. The total participation period and extensive follow-up allow evaluation of long-term treatment effects and patient survival.

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 evaluating the effectiveness of BDB-001 injection to induce remission in adults with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). This phase III, multicenter, randomized, double-blind, controlled study compares BDB-001 combined with cyclophosphamide followed by azathioprine or with rituximab. The trial focuses on patients diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) who require treatment with prednisone plus immunosuppressive therapy. Participants receive BDB-001 intravenously along with either cyclophosphamide followed by azathioprine or rituximab, both also given intravenously. Prednisone is part of the treatment regimen as well. The study assesses the safety and efficacy of this combination approach to induce disease remission. Treatment schedules follow standard dosing protocols for these medications. During the study, researchers monitor patients for remission using the Birmingham Vasculitis Activity Score (BVAS) at 24 weeks. Participants undergo regular assessments to evaluate disease activity and treatment response. Safety monitoring and follow-up visits are conducted throughout the trial duration to observe patient health and treatment effects.

Researchers are evaluating the diagnostic accuracy of an AI-integrated Capsule Gastroscopy (ACG) system designed for home-use simulation to detect upper gastrointestinal (UGI) abnormalities. This study compares the accuracy and time efficiency of AI-assisted reading with manual interpretation of ACG data, using conventional esophagogastroduodenoscopy (EGD) as the reference standard. The study addresses the challenge of limited access to traditional gastroscopy in China due to resource constraints and patient discomfort, aiming to find a more comfortable and accessible screening method. The study involves three phases: screening, examination, and follow-up. During the examination phase, participants undergo an ACG test in a simulated home environment by swallowing the capsule and following body position instructions via a mobile app. Within 24 hours, participants also receive a standard EGD procedure performed by blinded endoscopists for comparison. The ACG videos are read manually by experienced readers and independently analyzed with AI assistance to document gastric lesions, image quality, and cleanliness. Data are uploaded to cloud servers for remote reading. Participants provide informed consent and undergo eligibility screening before enrollment. During the trial, researchers monitor completion of the ACG exam and record any adverse events. The primary outcome is the diagnostic accuracy of the ACG system over about one year. Researchers also measure reading time and lesion detection details. After completing all cases, data are verified and analyzed to prepare the clinical trial report.