Zhang Zhou 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 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 AK112, a PD-1VEGF bispecific antibody, as a consolidation treatment for patients with limited stage small cell lung cancer who have not shown disease progression after concurrent chemoradiation therapy. This phase III, randomized, double-blind study aims to compare the effectiveness and safety of AK112 against a placebo in this specific patient group. Participants will receive either AK112 or a placebo intravenously every three weeks as consolidation therapy following their initial chemoradiation. The study includes two groups one receiving AK112 at a dose of 20 mgkg every three weeks, and the other receiving a matching placebo on the same schedule. Treatment continues under close monitoring to assess outcomes. Throughout the study, participants will undergo regular assessments including scans and evaluations to monitor progression-free survival and overall survival over approximately six years. Additional outcome measures include response rates and disease control rates assessed by both independent review and investigators, along with safety monitoring for adverse events. This long-term follow-up helps researchers understand how the treatments perform and their impact on patient health.

Researchers are evaluating the use of pegmolesatide, a long-acting erythropoiesis-stimulating agent ESA, in patients with renal anemia who are currently treated with hypoxia-inducible factor prolyl hydroxylase inhibitors HIF-PHIs. This trial aims to explore the safety and effectiveness of switching from HIF-PHIs to pegmolesatide, addressing the current need for longer-acting and safe medications. The study is a multi-center, prospective, open-label, randomized parallel-controlled trial enrolling 96 dialysis chronic kidney disease patients with anemia. Participants are divided into two groups based on their current weekly Roxadustat dose a low-dose cohort 210 mg and a high-dose cohort >210 mg and 360 mg. Within each cohort, patients are randomly assigned to receive pegmolesatide at different initial doses 2 mg, 4 mg, or 6 mg administered subcutaneously once every 4 weeks. The dose may be adjusted according to the drugs instructions. The treatment period lasts 12 weeks, followed by a 16-week follow-up period. During the study, researchers will monitor hemoglobin levels and other blood parameters at various intervals to assess the effects of pegmolesatide. Patients will undergo assessments including hemoglobin tests, red blood cell counts, and safety monitoring for adverse events. The primary measurement is the change in mean hemoglobin levels from baseline to 12 and 16 weeks. The total participation time for each patient is 28 weeks, including treatment and follow-up.

Researchers are evaluating the safety, effectiveness, and how the body processes a drug called YL201 when combined with Toripalimab, either with or without Cisplatin, in adults with recurrent or metastatic nasopharyngeal carcinoma. This open-label Phase IbII trial is conducted across multiple centers in China and focuses on patients whose cancer cannot be cured with local treatment. The study aims to better understand treatment effects in this advanced cancer setting. Treatment involves two groups one receiving YL201 plus Toripalimab and another receiving YL201 plus Toripalimab and Cisplatin. All study drugs are given by intravenous infusion. The trial includes a dose exploration phase to assess safety and efficacy of these combinations. Participants receive treatment according to randomized assignment to one of these regimens. Participants will be monitored for side effects, cancer progression, and response to treatment over about 36 months. Researchers will assess dose-limiting toxicities, treatment-emergent adverse events, progression-free survival, and other measures such as response rate and overall survival. The study also evaluates how YL201 and its metabolites behave in the body. Participants will undergo regular medical exams, imaging, and lab tests during the study period to track outcomes and safety.

Researchers are evaluating the effectiveness of Pumitamig compared to Pembrolizumab in adults with previously untreated advanced Non-Small Cell Lung Cancer NSCLC who have a PD-L1 expression level of 50% or higher. This Phase 3 randomized, double-blind study focuses on patients with locally advanced or metastatic NSCLC to better understand first-line treatment options. Participants receive either Pumitamig or Pembrolizumab as the study drug, given at specified doses on certain days. The study uses a parallel design with two treatment groups to compare these therapies as first-line options. The study is planned to continue until October 2031, with treatment and follow-up periods extending up to approximately 5 years for overall survival assessments. During the study, participants will have regular assessments to monitor disease progression and response to treatment using criteria like RECIST v1.1. Researchers will evaluate progression-free survival, overall survival, objective response rates, duration of response, disease control rate, and symptom changes related to lung cancer over time. Safety and treatment effects will be closely monitored throughout the study duration.

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 evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease COPD. This phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on participants already receiving inhaled maintenance therapy and who have experienced multiple COPD exacerbations in the previous year. The trial aims to understand tezepelumabs impact on reducing COPD flare-ups and improving lung function compared to placebo. Participants are randomly assigned to receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. The treatment period lasts between 52 and 76 weeks, followed by a 12-week safety monitoring period without treatment. Throughout the study, participants continue their inhaled COPD therapies, and their health is closely tracked to assess the study drugs effects. During the trial, participants will undergo various assessments including lung function tests, questionnaires measuring respiratory symptoms and quality of life, and blood tests to monitor drug levels and immune responses. Researchers will measure the annual rate of moderate or severe COPD exacerbations and other health outcomes over the study period. Safety will be monitored throughout treatment and during the follow-up period, with visits scheduled regularly to collect data and support participant care.

This trial is for adults who have had an acute ischemic stroke caused by a blood clot blocking a brain vessel. It focuses on people whose stroke occurred or was discovered more than 4.5 hours ago, including those who woke up with stroke symptoms. The study aims to find out if the medicine tenecteplase helps recovery when given after this 4.5-hour window, compared to standard medical care. Tenecteplase is already used within 4.5 hours after stroke onset, but this study tests its effect when given later. Participants are randomly assigned to one of two groups one receives a single injection of tenecteplase into a vein, and the other receives the usual standard treatment. Both groups have an equal chance of receiving either treatment. The study lasts about three months, starting with approximately one week of hospital stay. During the study, participants have seven clinical examinations or visits, with the final two visits conducted remotely from home to allow for easier participation. Throughout the study, doctors regularly assess participants recovery using a scale that measures disability and dependence in daily activities. They also monitor overall health and record any side effects. The main outcome measured is the level of recovery 90 days after treatment, comparing the two groups. This includes neurological improvement, bleeding events, and survival over the study period.

Researchers are conducting a Phase 1b clinical trial to study anisodine hydrobromide in patients who have acute ischemic stroke and are undergoing endovascular therapy. The main goals are to assess the safety and tolerability of the drug and to find the appropriate dose for future studies. This open-label, non-randomized trial uses a dose-escalation design to identify the maximum tolerated dose and recommended dose for Phase II trials. Participants receive anisodine hydrobromide intravenously at one of four dose levels 1.0 mg, 1.5 mg, 2.0 mg, or 2.5 mg twice daily for seven consecutive days alongside standard endovascular therapy. The first dose is given before vascular recanalization but must not delay the endovascular procedure. The drug is diluted in sodium chloride solution and infused over about 60 minutes. All participants also receive standard care for stroke, including mechanical thrombectomy and other procedures as needed. Throughout the study, participants are closely monitored for safety and neurological outcomes. Researchers will measure safety events within eight days of the first dose, neurological changes within 24 hours, stroke infarct volume at day 8, and functional recovery at day 90 using the modified Rankin Scale. Additional assessments include brain hemorrhage events and all-cause mortality within 90 days. The total participation duration extends to approximately three months to capture these outcomes and ensure safety monitoring.