Zhang Zhou Shi

Researchers are conducting a phase III, randomized, open-label, multicenter clinical trial to evaluate the safety and effectiveness of TQB2102 for injection compared to the chemotherapy regimen TCbHP in the neoadjuvant treatment of patients with HER2-positive breast cancer. The study aims to assess key outcomes including the total physiological complete response (tpCR), breast pathological complete response (bpCR), overall response rate (ORR), event-free survival (EFS), invasive disease-free survival (IDFS), overall survival (OS), and adverse events (AEs). Participants will receive either TQB2102, a HER2 dual-antibody drug conjugate, or the TCbHP chemotherapy combination consisting of Trastuzumab, Pertuzumab, Docetaxel, and Carboplatin. Treatment is given before surgery as part of the neoadjuvant approach. The study compares these two treatment regimens to determine their relative effectiveness and safety in this setting. During the study, participants will be monitored for response to treatment and side effects over a period of up to 26 months from the start of the study. Evaluations by an Independent Review Committee will include measuring the rate of total physiological complete response. Additional assessments will track other clinical outcomes and adverse events. Participants must comply with study requirements, including surgery after neoadjuvant therapy if appropriate, and safety will be closely observed throughout the trial.

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.

This trial studies patients with limited stage small cell lung cancer who have not shown disease progression after concurrent chemoradiation therapy. It is a randomized, double-blind, phase III clinical study designed to compare the effectiveness and safety of the drug AK112 against a placebo as a consolidation treatment. The goal is to evaluate the potential benefits of AK112 in improving outcomes for these patients. Participants receive either AK112 at a dose of 20 mg/kg or a placebo, both administered intravenously every three weeks (Q3W). The treatment is given as consolidation therapy following initial chemoradiation, aiming to maintain disease control. The study involves two groups: one receiving AK112 and the other receiving placebo, with both treatments delivered under double-blind conditions. Throughout the trial, researchers monitor participants for up to approximately six years, focusing on progression-free survival and overall survival as primary outcomes. Patients undergo regular assessments to track disease status and safety, including blinded independent center reviews. The long-term follow-up ensures comprehensive evaluation of treatment effects and participant safety over time.

Researchers are evaluating patients with sepsis caused by abdominal infections to understand the progression of enterorenal syndrome using gastrointestinal ultrasound combined with renal artery resistance index measurements. The study divides patients admitted to the Emergency Intensive Care Unit (EICU) into survival and death groups based on ultrasound assessments of gastrointestinal function, superior mesenteric artery blood flow, and renal artery resistance index. This approach aims to provide objective information to support clinical decisions and improve rescue success rates. The study involves no specific treatment interventions but focuses on diagnostic testing through ultrasound examinations. Measurements are taken at several time points: upon ICU admission (0 hours), after fluid resuscitation (6 hours), and at 24, 48, 72, and 120 hours after ICU admission. Key indicators monitored include the cross-sectional area of the gastric antrum, superior mesenteric artery flow velocity, colon diameter and peristalsis frequency, renal artery resistance index, central venous pressure, oxygen saturation, inflammatory markers, blood lactic acid and creatinine levels, fluid intake, and bladder pressure. Participants are adult patients aged 14 to 85 years diagnosed with intra-abdominal sepsis and septic shock. Researchers assess these measurements alongside survival outcomes to evaluate the development of enterorenal syndrome. The primary outcome is survival rate, and the study's data collection and monitoring span the first five days of ICU admission. This comprehensive evaluation aims to enhance understanding of disease progression and support improved clinical care strategies.

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.

This trial investigates the effectiveness of Pumitamig compared to Pembrolizumab in adults with advanced Non-Small Cell Lung Cancer (NSCLC) who have not received prior treatment and whose tumors express PD-L1 at 50% or higher. The study targets individuals with locally advanced or metastatic NSCLC, focusing on those with measurable disease and good performance status. It is a Phase 3 randomized, double-blind study designed to compare these two treatments as first-line options for this patient group. Participants will receive either Pumitamig or Pembrolizumab at specified doses on scheduled days. The treatments are given as monotherapy, meaning each participant receives only one of these drugs throughout the study. The study does not mention additional treatment phases or extensions, focusing on the direct comparison of these two drugs for initial treatment. Throughout the study, researchers will assess how long participants live without their cancer worsening, using standardized criteria over about three years. Overall survival will also be tracked for up to five years. Participants will be monitored regularly to evaluate their response to treatment and overall health. Safety and effectiveness outcomes will be gathered through medical assessments consistent with clinical trial standards for NSCLC.

Researchers are evaluating the efficacy and safety of a combination budesonide and albuterol metered dose inhaler (MDI) compared with an albuterol sulfate MDI in symptomatic Chinese adults with asthma. This Phase III, randomized, double-blind, multicenter, event-driven study aims to reduce the risk of severe asthma exacerbations in this population. The study will enroll approximately 790 participants who meet specific asthma-related eligibility criteria. The study includes three periods: a screening period of 14 to 28 days, a treatment period lasting at least 24 weeks and up to 52 weeks, and a safety follow-up period occurring about two weeks after the final visit. Participants will be randomly assigned to one of two treatment groups, receiving either the budesonide/albuterol MDI or the albuterol sulfate MDI as needed for asthma symptoms or before exercise, alongside their usual maintenance therapy. Participants will undergo assessments including lung function tests, asthma control questionnaires, and monitoring of severe asthma exacerbations throughout the treatment period. Researchers will track the time to the first severe asthma exacerbation as the primary outcome. Safety will be monitored during the follow-up period, and participants must demonstrate the ability to use the inhaler correctly and comply with study procedures throughout the trial.

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). These participants must have a history of COPD for at least one year and have experienced multiple COPD exacerbations despite using inhaled maintenance therapy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on those who have had at least two moderate or one severe exacerbation in the prior year while on inhaled triple or dual therapy. Participants will receive monthly subcutaneous injections of either one of two doses of tezepelumab or a placebo. Treatment will last for a minimum of 52 weeks and up to 76 weeks. After the treatment period, there will be a 12-week off-treatment safety follow-up to monitor any lasting effects or safety concerns. During the study, researchers will assess the participants' lung function and monitor the annual rate of moderate or severe COPD exacerbations. Participants will undergo screening to confirm eligibility based on lung function tests, eosinophil counts, and symptom scores. Safety will be closely monitored throughout the treatment and follow-up periods to evaluate adverse effects and overall participant health.

Researchers are evaluating whether using a balloon guide catheter with flow arrest during mechanical thrombectomy improves the rate of first-pass reperfusion, measured by the expanded Thrombolysis in Cerebral Infarction score (eTICI 2c-3), for patients who have had an acute ischemic stroke caused by occlusion of the internal carotid artery. The study compares this method to using a standard guide catheter or neurovascular sheath without flow arrest in a randomized controlled trial setting. Participants will be randomly assigned to one of two groups: one group will receive mechanical thrombectomy treatment combined with a balloon guide catheter that allows flow arrest, while the other group will receive mechanical thrombectomy with a standard guide catheter or neurovascular sheath. Both groups undergo the thrombectomy procedure to remove the blood clot causing the stroke. The study focuses on the effectiveness of these catheter methods during the intervention. During the study, participants will be monitored for the rate of successful first-pass reperfusion, defined as achieving an eTICI score of 2c-3 during the perioperative period. Researchers will assess clinical and imaging outcomes to evaluate the treatment's impact. Participants must be adults aged 18 or older with acute ischemic stroke due to internal carotid artery occlusion and will be followed throughout the procedure and immediate recovery to measure outcomes.