Foshan

Researchers are evaluating TQB2102, an antibody-drug conjugate designed to target tumor cells with a potent drug payload, for its effectiveness and safety in treating locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 gene abnormalities. This Phase 2 study focuses on patients whose cancer is either inoperable or has recurred and who have not responded to previous standard treatments. The goal is to assess the overall response rate up to 8 months after starting treatment. Participants may receive TQB2102 alone or in combination with Benmelstobart injection, a monoclonal antibody targeting PD-L1. TQB2102 combines a humanized antibody against HER2 with a topoisomerase I inhibitor payload, aiming to specifically attack cancer cells. The treatments are administered by injection, and the study examines their safety and effectiveness in this patient population. During the study, participants will be monitored closely with evaluations including tumor measurements based on standard criteria. Researchers will track treatment responses and any side effects to determine safety and overall benefit. The study includes adults aged 18 to 75 years with specific performance status and survival expectations, and it also requires contraception use for participants of childbearing potential. The total duration includes baseline through up to 8 months of treatment response assessment.

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are studying the gut microbiome in people with several serious chronic diseases in China, including various cancers, hypertension, epilepsy, and kidney disease. The study aims to better understand the differences and similarities in gut microbiome patterns linked to these diseases and different regions, and how these patterns affect microbiome-based diagnostic tests. This work is important because past research has shown links between microbial imbalances and disease, but variability between studies has made it hard to draw clear conclusions. This observational study will recruit 500 patients diagnosed with each target disease and 500 healthy control participants matched by age and sex. Researchers will collect detailed information about participants' demographics, lifestyle, diet, medications, and health status. Biological samples including feces, saliva, urine, and blood will be collected for analysis. There is no active treatment or intervention; the study focuses on characterizing the microbiome and related health data. Participants will undergo assessments of their medical history and lifestyle, with sample collections to analyze microbiome and biochemical markers. Researchers will measure the baseline microbiome to identify disease-associated signatures. The study requires participants to be aged 18 to 75 and to have lived in the hospital's province for at least three years. Safety monitoring is observational, with no study treatments given. The total participant involvement includes data and sample collection for cross-sectional analysis.

Researchers are evaluating the safety and effectiveness of two antibiotic treatments, omadacycline and moxifloxacin, in Chinese adults with community-acquired bacterial pneumonia (CABP). This Phase 3b study is designed as a bridging trial to confirm whether omadacycline works as well as moxifloxacin in this specific population, building on results from a global CABP trial. Participants will receive either omadacycline or moxifloxacin through intravenous or oral routes. The treatments are given as a course, with details on dosing schedules not specified. The study compares these two drugs directly to assess their clinical efficacy and safety in treating CABP. During the study, participants will be monitored and evaluated for their clinical response at 18 months after therapy. Researchers will assess symptoms, vital signs, and overall health related to pneumonia to determine treatment success. Safety and efficacy data collected throughout the study will help understand how well each drug performs in this patient group.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating zorifertinib as a first-line treatment in patients with advanced non-small cell lung cancer (NSCLC) that has mutations in the epidermal growth factor receptor (EGFR) and has spread to the central nervous system (CNS). This study is a patient-centered, multi-center, prospective trial designed to assess the survival benefits and safety of zorifertinib compared to other EGFR tyrosine kinase inhibitors (EGFR-TKIs) for these patients. Participants in Cohorts A and B will receive zorifertinib as their first treatment. The study compares zorifertinib with other anti-tumor treatments used as first-line therapy. Patients in Cohort A must meet specific additional criteria, including no prior treatment with chemotherapy or EGFR-TKIs and stable health conditions. During the study, participants will be monitored for overall survival for up to 36 months. Researchers will assess safety, treatment responses, and clinical outcomes through regular evaluations. Participants will provide informed consent and agree to follow study procedures throughout the treatment and observation periods.

Researchers are evaluating how well oral icotrokinra works, its safety, and how well patients tolerate it in adults and adolescents with moderately to severely active ulcerative colitis, a chronic condition where the colon lining becomes inflamed and develops ulcers. This is a Phase 3 study aimed at finding effective treatments for this condition using a rigorous comparison. Participants will receive either icotrokinra tablets or placebo tablets taken by mouth. The study includes an induction phase and a maintenance phase, with adults participating in a randomized, double-blind, placebo-controlled design, while adolescents join an open-label maintenance study. Throughout the study, researchers will monitor clinical remission rates at 12 weeks during induction and at 40 weeks during maintenance. Participants will undergo assessments including endoscopic evaluations and pregnancy tests for females of childbearing potential. Safety and tolerability will be closely observed, with the total study duration covering both induction and maintenance periods.

Chronic kidney disease (CKD) includes various conditions that cause damage to the kidneys or reduce their function. CKD affects about 10.8% of the population in China, making it a major health concern due to its high prevalence and associated risks, including progression to kidney failure and increased cardiovascular problems. This study aims to better understand CKD in China by investigating its occurrence, progression, treatment, and related risk factors using real-world patient data from multiple centers. The research is a multi-center, prospective, observational study involving a large and diverse group of participants from mainland China. It uses a standardized data network for efficient collection and analysis of patient information. The study includes people diagnosed with CKD, those at risk due to conditions like hypertension or diabetes, and healthy individuals, allowing for broad and detailed analysis. The study does not involve specific treatments but focuses on observing patients over time. Participants will be followed for up to 5 years to monitor the development or progression of CKD and related health outcomes. Researchers will collect and analyze clinical data and track kidney function and disease status over this period. This long-term observation aims to provide valuable insights into CKD prevention and management, helping to reduce the disease burden in China.

Researchers are evaluating the real-world effectiveness of Repatha® combined with standard of care (SOC) compared to SOC alone in reducing major cardiovascular events. The study focuses on people with established atherosclerotic cardiovascular disease (ASCVD) who are treated according to local clinical practice. The goal is to see how these treatments affect the risk of cardiovascular death, heart attacks, stroke, hospitalization for unstable angina, or coronary revascularization. Participants will either be prescribed Repatha® in addition to their existing SOC treatment or continue with SOC alone. The study follows these participants over time to observe outcomes. Treatments are given according to local guidelines and approved labels, reflecting real-world medical care. During the study, researchers will monitor participants for the time until the first occurrence of any major cardiovascular event listed above, for up to 72 months. Participants will undergo regular assessments to track their health status and treatment effects. Safety and effectiveness are observed through ongoing real-world data collection in this prospective, observational study.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.