Shao Xing Shi

Researchers are evaluating the effectiveness and safety of TQB2102 for injection compared to a standard chemotherapy regimen called TCbHP in patients with HER2-positive breast cancer. This phase III, randomized, open-label, multi-center study focuses on neoadjuvant treatment, which is therapy given before surgery. The study aims to measure the total pathological complete response and other outcomes such as event-free survival and overall survival. Participants receive either TQB2102 for injection at 6 mgkg by intravenous infusion every 3 weeks for 8 cycles or a combination of Trastuzumab, Pertuzumab, Docetaxel, and Carboplatin given intravenously every 3 weeks for 6 cycles. The study monitors participants throughout the treatment period and collects data on tumor response and side effects. During the study, participants will undergo assessments including tumor response evaluations by independent review and investigators, safety monitoring for adverse events, and laboratory tests. Follow-up will continue for up to 50 months after the start of the study to observe long-term outcomes. Participants are expected to comply with contraceptive use requirements and attend all scheduled visits for treatment and evaluations.

Researchers are observing patients who receive Siltartoxatug Injection, also known as Sintetol4, to prevent tetanus following injury. This large-sample, real-world registry aims to document injury and wound conditions and evaluate clinical outcomes related to tetanus prevention. The study focuses on collecting safety information and any adverse reactions after receiving the injection. Participants in this observational study receive Siltartoxatug Injection as part of their tetanus prophylaxis after injury. The study does not involve randomization or comparison groups but follows patients over time to monitor outcomes. A key part of the study is the follow-up at 90 days after administration to assess whether tetanus develops and to record any safety events. During the study, patient injury details and wound conditions will be carefully noted. Safety data will be selectively collected to identify any adverse reactions or serious events linked to Siltartoxatug use. The main outcome measure is the occurrence of tetanus within 90 days post-injection. Participants are followed for this 90-day period to evaluate treatment outcomes and safety.

Researchers are evaluating the real-world effectiveness of Repatha combined with standard of care SOC compared to SOC alone in Chinese adults with established atherosclerotic cardiovascular disease ASCVD. The study focuses on the risk of major cardiovascular events such as cardiovascular death, heart attack, stroke, hospitalization for unstable angina, or coronary revascularization. This observational study aims to understand how these treatments work when used according to local clinical practice. Participants are divided into two groups based on treatment decisions made independently of the study enrollment those receiving Repatha with SOC and those receiving SOC alone. The study observes these participants over a period of up to 72 months to assess outcomes. Treatment choices follow local guidelines and approved labels, ensuring minimal impact on routine care. During the study, participants undergo regular monitoring for cardiovascular events and changes in cholesterol levels, including low-density lipoprotein cholesterol LDL-C. Researchers also track adverse events and reactions throughout the follow-up period. Participants remain under usual care, and data collection occurs alongside routine clinical visits, with a total participation time of up to six years.

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 whether troxerutin can help prevent blood clots in adults with mild or severe COVID-19. This Phase 1 clinical trial aims to compare troxerutin with a placebo to see if it reduces thrombotic events and to assess the safety of troxerutin in this patient group. The study addresses key questions about how often blood clots occur and what side effects may happen during treatment. Participants will receive either oral troxerutin tablets or matching placebo tablets twice daily for 7 days. Some groups will also receive low molecular weight heparin once daily. The study includes four visits to the clinic on days 1, 4, 7, and 28 for checkups and tests. Participants will keep a diary tracking symptoms, blood clot events, bleeding events, and a specific blood platelet condition related to heparin. During the study, researchers will monitor participants health through clinical assessments and laboratory tests to measure the number of patients in a prothrombotic state over 7 days. Safety will be evaluated by recording any adverse events through 28 days. The total involvement includes treatment and follow-up visits over about four weeks, ensuring close observation of participants responses and any side effects.

Researchers are evaluating the efficacy and safety of two inhalers, BDA MDI budesonide and albuterol and AS MDI albuterol sulfate, in reducing severe asthma attacks among symptomatic Chinese adults with asthma. This Phase III, randomized, double-blind, multicenter study involves about 1000 participants who have been diagnosed with asthma and continue to experience symptoms despite maintenance therapy. Participants will be randomly assigned to receive either BDA MDI 160180 mcg two puffs of 8090 mcg or AS MDI 180 mcg two puffs of 90 mcg as needed to relieve asthma symptoms or before exercise. The study includes a screening period lasting 14 to 28 days, followed by a treatment period of at least 24 weeks and up to 52 weeks, and concludes with a safety follow-up about two weeks after the last treatment visit. During the trial, participants will attend regular visits to monitor their asthma control and lung function. Researchers will assess the time to the first severe asthma exacerbation, the rate of exacerbations, steroid use, and responses to asthma control questionnaires. Safety will be carefully followed during and after treatment, with the total participation lasting up to approximately one year.

Researchers are investigating the use of an intelligent navigation system delivered through the Ali Pay applet to help patients with acute ischemic stroke AIS. The study focuses on whether this system can reduce delays before hospital arrival and improve functional outcomes for AIS patients receiving reperfusion therapy. The low treatment rates and delays in pre-hospital and in-hospital care have motivated this research, as most AIS patients arrive at hospitals without emergency medical services. The study compares two groups one with access to the Ali Pay intelligent navigation applet and one without. This applet includes three key functions stroke education sent regularly to users, stroke recognition using questionnaires, voice interaction, and facial recognition, and hospital recommendation based on real-time traffic and hospital delays to guide patients to centers likely to provide reperfusion therapy. Patients in regions where the applet is available form the experimental group, while those in other regions form the control group. Participants diagnosed with AIS and undergoing reperfusion therapy within 24 hours of onset are followed in this randomized trial. Researchers will assess outcomes like the modified Rankin scale scores at 90 days after reperfusion therapy to measure functional status. They will also track timing from stroke onset to treatment and hospital arrival, the proportion receiving treatment beyond recommended time windows, and rates of mechanical thrombectomy. The study starts in April 2025 and continues until May 2026.

Researchers are evaluating the real-world use of upadacitinib tablets in adolescents and adults with moderate to severe atopic dermatitis AD, a skin condition causing rash and itching due to inflammation. This observational study will include about 1000 participants who have been prescribed upadacitinib by their physicians in accordance with local guidelines in China. The purpose is to understand treatment patterns and patient outcomes in everyday clinical practice. Participants will receive oral upadacitinib tablets as prescribed by their physicians following the local approved label. The study does not assign or alter treatment but observes how upadacitinib is used in routine care. The study will take place at up to 40 sites across China and participants will continue their prescribed treatment without additional interventions. During approximately 12 months of follow-up, participants will attend regular clinic visits as part of their routine care. Researchers will collect patient-reported data through electronic diaries and apps to monitor treatment adherence, dose changes, interruptions, or permanent discontinuations. The study aims to measure how well patients follow their prescribed regimen and any changes over time, with no added burden beyond normal clinical visits.

Researchers are evaluating the effectiveness of combining anlotinib hydrochloride capsules with penpulimab injection as an additional treatment after radical surgery or ablation for patients with hepatocellular carcinoma HCC who are at high risk of cancer returning. This Phase 3 randomized, double-blind, placebo-controlled study aims to compare this combination therapy to a placebo to assess recurrence-free survival RFS over a period of up to three years. Participants receive either the anlotinib capsules plus penpulimab injection or matching placebos in 21-day treatment cycles. The study groups include an experimental arm receiving both active drugs and a control arm receiving placebo capsules and injections. This approach helps researchers understand how well the combination works in preventing cancer recurrence after initial treatment. Throughout the study, participants will have their health monitored regularly, including assessments of recurrence-free survival, time to cancer recurrence, time to spread outside the liver or vascular invasion, overall survival, and response rate after any recurrence. These evaluations will occur from the start of the study and continue for up to three years to track long-term outcomes and safety.

Researchers are evaluating the safety and effectiveness of a pulsed electric field ablation system developed by Suzhou Hengruihongyuan Medical Technology Co., Ltd. for treating symptoms of chronic bronchitis in adults with moderate to severe chronic obstructive pulmonary disease COPD. This prospective, randomized, sham-controlled, multicenter clinical trial will include 210 patients, who will be assigned to either the treatment group or a sham procedure group in a 21 ratio. The treatment involves a staged bronchial rheoplasty procedure where pulsed electric fields are applied first to the right lung and then the left lung about one month later. Patients in the sham group will undergo a similar staged procedure without the energy delivery. The study will monitor patients over various time points up to 12 months to assess treatment effects. Participants will undergo several assessments including the COPD Assessment Test CAT score, St. George Respiratory Questionnaire SGRQ-C, dyspnea scales, pulmonary function tests FEV1 and FEV1FVC ratio, and a six-minute walking test. Evaluations occur at 3, 6, and 12 months after treatment. The study also measures the rate of COPD exacerbations and technical success of the procedure shortly after device removal. Safety and adherence are monitored throughout the study duration, which extends up to 12 months post-treatment.