Yun Cheng 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 effectiveness and safety of TQB2102 injection compared to a combination of docetaxel, trastuzumab, and pertuzumab in treating adults with HER2 positive recurrent or metastatic breast cancer. This Phase III, randomized, open-label, multicenter trial aims to compare these treatments in patients who have not received systemic anti-tumor therapy during their recurrence or metastasis stage, except for limited first-line endocrine therapy. Participants must have HER2 positive invasive breast cancer confirmed by pathology and measurable lesions. Participants are randomly assigned to one of two treatment groups in equal numbers. One group receives TQB2102, a next-generation HER2 Antibody-Drug Conjugate, while the other group receives docetaxel combined with trastuzumab and pertuzumab as a positive control. The study monitors the patients during treatment and collects data on tumor response and progression. During the study, participants undergo regular assessments including imaging to measure tumor size and progression according to RECIST 1.1 criteria. Researchers track the objective response rate and progression-free survival for up to approximately 30 months. Safety and adverse events are monitored throughout the trial, and participants must have good compliance and major organ function to continue. The study includes long-term follow-up to assess treatment outcomes and tolerability.

This trial evaluates the effectiveness and safety of the GR2001 injection compared to Human Tetanus Immunoglobulin (HTIG) for preventing tetanus. It is a Phase III study focused on patients suspected of tetanus exposure through dirty or contaminated wounds. The study aims to assess the immunogenicity and pharmacokinetics of GR2001 as a potential alternative to HTIG. Participants will receive either the GR2001 injection or HTIG on the first day of the study. GR2001 is provided in a 5mg/1ml vial packaged with specialized materials to ensure safety and stability. HTIG is a licensed human tetanus immunoglobulin derived from human plasma and prepared in injectable form. Both treatments are administered once for tetanus prophylaxis. During the study, researchers will measure the increase in anti-tetanus antibody levels up to 12 hours after treatment to evaluate immune response. Participants must provide informed consent and will be monitored for safety and any adverse reactions. The study includes adults aged 18 and older with suspected tetanus exposure, and the overall participation involves initial treatment and short-term antibody measurement for effectiveness.

Researchers are evaluating the protective effects, safety, and immune response of an 11-valent recombinant human papillomavirus (HPV) vaccine called Hansenulapolymorpha in Chinese women aged 18 to 45 years. This Phase III randomized, blinded, placebo-controlled trial involves 13,500 women divided into three age groups: 18-26, 27-35, and 35-45 years. The study aims to assess the incidence of cervical intraepithelial neoplasia grade 2 or higher (CIN2+) associated with various HPV types after vaccination. Participants receive either the 11-valent HPV vaccine or a placebo through intramuscular injections in the upper arm deltoid muscle. The vaccination schedule includes three doses given at 0, 2, and 6 months. The trial compares the vaccine's effects against placebo across the different age groups, following strict immunization timing. During the study, women attend follow-up visits and provide information through diary cards and contact forms. Researchers monitor safety, immune responses, and HPV-related cervical changes, including CIN2+ occurrences one month after the third dose. The trial also includes pregnancy testing before vaccination and requires effective contraception during the study. Total participation includes vaccination and follow-up over approximately six years to evaluate long-term outcomes.

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 conducting a prospective, multi-center, non-interventional cohort study across China to investigate Drug-induced Liver Injury (DILI). The study aims to explore the clinical characteristics, responsible drugs or herbs, patient outcomes, and risk factors associated with DILI. An important goal is to identify new serum markers that could help predict the prognosis of this condition. The study also seeks to develop and validate a prognostic model incorporating these novel serum markers to improve patient care in China. Participants will be followed in a nationwide standardized cohort with long-term monitoring to collect detailed prognostic data on DILI. The study does not involve experimental treatments but focuses on observation and data collection to help understand DILI better. No specific interventions are delivered as part of this research. During the study, participants will undergo evaluations to confirm diagnosis and monitor their liver health over time. Researchers will measure primary outcomes including death or liver transplantation within one year and the occurrence of acute liver failure within one year. The study involves ongoing assessments to gather clinical data and validate the prognostic model based on novel serum biomarkers, aiming to enhance future management of DILI.

Researchers are evaluating whether the medicine vicadrostat, combined with empagliflozin, helps adults with chronic heart failure (HF) who have a weakened heart pumping function, specifically a left ventricular ejection fraction (LVEF) below 40%. Eligible participants must have been diagnosed with chronic HF at least 3 months before joining. The study is a Phase III trial designed to compare the effects of vicadrostat plus empagliflozin against placebo plus empagliflozin in people with symptomatic chronic HF classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups. One group takes tablets containing vicadrostat and empagliflozin, while the other group takes placebo tablets that look like vicadrostat along with empagliflozin. Tablets are taken once daily for a period ranging from about 6 months up to about 3.5 years. Participants continue their usual heart failure treatments during the study. The study is double-blind, meaning neither the participants nor the study staff know who is receiving which treatment. During the study, participants regularly visit the study site or may have phone contacts for follow-up. They answer questions about their health and well-being. Doctors monitor and record any worsening of heart failure symptoms, hospital visits due to heart failure, or deaths. They also check participants' overall health and note any side effects. The main outcome measured is the time until a participant experiences cardiovascular death, hospitalization for heart failure, or an urgent heart failure visit, over up to 43 months of follow-up.

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.

Researchers are evaluating the effectiveness and safety of TQC2731 injection, a humanized monoclonal antibody that targets Thymic Stromal Lymphopoietin (TSLP) to block its pathway and reduce inflammation. The study focuses on adults aged 18 to 75 years with chronic rhinosinusitis and nasal polyps (CRSwNP), a condition involving persistent nasal symptoms and polyps in both nostrils. This is a Phase III clinical trial designed to assess improvements in nasal polyp size and nasal congestion over 24 weeks. Participants will be randomly assigned to receive either TQC2731 injection or a placebo. The study involves monitoring the nasal polyp score (NPS) and nasal congestion score (NCS) from baseline through 24 weeks to evaluate changes. Both groups will continue using a stable dose of intranasal corticosteroids during the study. The trial is double-blind and placebo-controlled, ensuring that neither participants nor researchers know which treatment is given. During the study, participants will undergo nasal endoscopy to assess polyp size and daily or weekly symptom scoring for nasal congestion. Researchers will track adherence to nasal spray use and symptom recording through electronic diaries. Safety will be monitored throughout, and participants will be followed for 24 weeks to measure changes in nasal polyp and congestion scores as primary outcome measures.

This research aims to evaluate the safety and effectiveness of an interleukin-6 receptor inhibitor called tocilizumab combined with endovascular therapy in patients who have experienced an acute posterior circulation large-vessel occlusion stroke. This phase III, randomized, double-blind, placebo-controlled trial is investigator-initiated and conducted at multiple centers. The goal is to see if adding tocilizumab can improve outcomes for these stroke patients. Participants will be randomly assigned to receive either tocilizumab or a placebo. The tocilizumab dose is 240 mg diluted in saline to a total volume of 100 mL, given intravenously immediately after randomization within 30 minutes, infused over more than one hour. The placebo group will receive an equivalent volume of saline solution under the same conditions. All participants will undergo emergency endovascular treatment as part of their stroke care. During the study, patients will be monitored and assessed for their recovery using the modified Rankin Scale at 90 days to determine the proportion achieving scores of 0 to 3, indicating favorable outcomes. Researchers will also observe safety and other clinical measures throughout the trial. The study involves obtaining informed consent and careful follow-up to evaluate treatment effects and patient safety over the course of the study period.