Le Shan Shi

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 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.

This trial investigates the effects of TQA2225/AP025, a recombinant human FGF21-Fc fusion protein, in adults with Non-Alcoholic Steatohepatitis (NASH). It is a randomized, double-blind, placebo-controlled Phase II study designed to evaluate the safety and effectiveness of two different doses (25mg and 50mg) of this drug compared to a placebo. Participants have a confirmed diagnosis of NASH based on liver biopsy and imaging, and the study aims to assess changes in liver health over time. Participants receive either 25mg or 50mg of TQA2225/AP025 or a matching placebo, and the treatment is administered during the study period. The trial compares the impact of these doses on liver fibrosis and inflammation, as measured by liver biopsy scores and imaging results. The study includes a treatment duration of 48 weeks, during which the drug's effect on liver tissue is closely monitored. During the study, participants undergo liver biopsies at baseline and after 48 weeks to evaluate liver changes. Additional assessments include MRI scans to measure liver fat content, laboratory tests to monitor liver enzymes and kidney function, and safety evaluations. Researchers will track participants' adherence to the treatment and monitor any side effects or changes in health status throughout the 48-week period.

This research evaluates the detection rates of colorectal adenomas using two different colonoscopy techniques: enhanced white light imaging (E-WLI) and conventional white light imaging (WLI). The study specifically compares adenoma detection rates, sessile serrated lesion detection rates, total polyp detection rates, and advanced adenoma detection rates. It also examines the characteristics of polyps observed with both imaging methods, including their size and location. Participants are randomly assigned to undergo colonoscopy using either the E-WLI or the WLI technique during both insertion and withdrawal phases. Colonoscopies are performed by experienced specialists using endoscopes equipped with "Xiaohua Tanying" technology. Bowel preparation is assessed before the procedure, and all detected polyps are observed with both imaging modes, documented, and removed or biopsied as necessary. The procedures include careful timing and photographic documentation to ensure thorough examination. Throughout the study, participants undergo standard monitoring and management, including anesthesia and assessment of bowel preparation quality. Data collected include polyp details, procedure times, and pathology results. The primary outcome measured is the adenoma detection rate within 14 days post-procedure. The study includes adults aged 45 to 85 undergoing colonoscopy for screening, positive fecal tests, gastrointestinal symptoms, or follow-up after polyp treatment, with ongoing safety and effectiveness assessments during the trial.

Researchers are evaluating the safety and effectiveness of low-dose tenecteplase in elderly patients who have experienced an acute ischemic stroke. This prospective, multicenter, randomized controlled Phase 4 trial focuses on patients aged 70 years and older who receive treatment within 4.5 hours of stroke onset. The study aims to compare low-dose tenecteplase with the standard dose to understand its impact on stroke recovery in aging patients. Participants are randomly assigned to one of two groups: a low-dose group receiving tenecteplase at 0.175 mg/kg (up to 17.5 mg per patient) or a standard-dose group receiving tenecteplase at 0.25 mg/kg (up to 25 mg per patient). Treatment is administered intravenously as thrombolysis. The trial monitors patients closely to assess how these dosing strategies affect recovery and safety. During the study, researchers will evaluate neurological function using the Modified Rankin Scale 90 days after treatment, measuring the percentage of participants who achieve a score of 0 or 1, indicating no symptoms or no significant disability. Patients will undergo neurological assessments and safety monitoring throughout the trial. The study ensures informed consent and collects relevant clinical data to support its findings on tenecteplase use in elderly stroke patients.

Researchers are investigating the potential for patients with severe asthma treated with Tezepelumab to safely reduce their background maintenance asthma medications while keeping their asthma symptoms under control. This Phase 3b study focuses on Chinese patients who have severe asthma and are currently using medium to high doses of inhaled corticosteroids combined with long-acting beta-agonists, with or without additional controllers. The goal is to evaluate the safety and effectiveness of stepping down maintenance therapy after starting Tezepelumab treatment. This is a single-arm, prospective study conducted at about 70 sites across China, enrolling approximately 400 patients aged 12 to 80 years. Participants will receive Tezepelumab while maintaining their existing asthma controller regimens initially. Over the study period, background maintenance therapy will be gradually reduced under close supervision to assess if asthma control remains stable. The total duration for each participant is up to 52 weeks. During the study, patients will be regularly monitored to evaluate their ability to reduce standard asthma controller medications while maintaining symptom control. Assessments include lung function tests, asthma control questionnaires, documentation of exacerbations, and safety evaluations. The main outcome measures focus on the potential to lower maintenance therapy within 36 weeks after starting Tezepelumab without losing asthma control. Ongoing safety monitoring and long-term observation will continue throughout the study period.