Mei 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 efficacy and safety of a new antibody-coupled drug called TQB2102 for injection in patients with unresectable locally advanced, recurrent, or metastatic HER2-positive gastroesophageal adenocarcinoma. This Phase II study focuses on how TQB2102 works in combination with Benmelstobart Injection or Penpulimab Injection, with or without chemotherapy, to target HER2 proteins on tumor cells and potentially improve treatment outcomes. The study aims to assess the Objective Response Rate (ORR) over about one year of participation. The treatments being studied include TQB2102 combined with Benmelstobart and chemotherapy or TQB2102 combined with Penpulimab and chemotherapy. TQB2102 is designed to bind more effectively to tumor cell HER2 proteins, while Benmelstobart and Penpulimab are antibodies that may help the immune system target cancer cells. Different dosing regimens of TQB2102 (6 mg or 7.5 mg) are being evaluated, and chemotherapy may be included depending on the treatment group. Participants will be monitored through regular evaluations during the study, which lasts approximately one year. Researchers will measure tumor response and safety outcomes, including lab tests and imaging to confirm measurable lesions according to RECIST 1.1 criteria. The study also involves reviewing previous PD-L1 expression test results or collecting tumor tissue for testing. Safety is closely observed, and participants must meet specific health criteria to join and continue in the trial.

Researchers are evaluating TQB2102, a new antibody-drug conjugate designed to target tumor cells in patients with recurrent or metastatic advanced gynecological tumors. This Phase 2 study focuses on assessing the safety and effectiveness of TQB2102, which combines a humanized antibody against HER2 with a powerful drug payload to kill cancer cells more specifically and potently than traditional treatments. The study includes patients who have not responded successfully to previous platinum-based chemotherapy. Participants will receive TQB2102 injections, which is a HER2 dual-antibody-drug conjugate. The treatment is given to women with measurable lesions confirmed by RECIST 1.1 criteria, and who have varying levels of HER2 expression in their tumor tissue. Women of childbearing potential must have a negative pregnancy test before starting and agree to use highly effective contraception throughout the study. The treatment period and dosing schedules are designed to monitor the drug's impact carefully. Throughout the study, participants will be closely monitored for overall response rate up to 12 months. Assessments include regular evaluations of tumor response, safety checks, and compliance with treatment. The study excludes patients with certain health conditions, recent surgeries, or other treatments that might interfere. The total duration and detailed follow-up procedures ensure thorough observation of TQB2102's effects and participant safety.

Researchers are evaluating a new treatment approach for patients with advanced non-small cell lung cancer (NSCLC) that has a specific EGFR mutation. These patients have not cleared circulating tumor DNA (ctDNA) after initial treatment with osimertinib alone, which is linked to poorer progression-free survival. This phase II study aims to explore the safety and effectiveness of combining osimertinib with sacituzumab tirumotecan in patients who still have positive ctDNA after starting osimertinib treatment. The study includes two groups based on ctDNA test results after one 3-week cycle of osimertinib monotherapy. Patients with positive ctDNA enter Cohort 1 and receive intravenous sacituzumab tirumotecan every two weeks plus daily oral osimertinib at standard doses until disease progression or other stopping criteria. Those with negative ctDNA continue osimertinib alone in an observational Cohort 2 with treatment choices made by their doctors. Participants will undergo tumor assessments and ctDNA tests to guide group assignment. Researchers will monitor disease progression, survival without progression, side effects, and overall safety. The main outcome is progression-free survival, tracked for up to 36 months from start of combination treatment. Participants are expected to comply with scheduled visits and procedures throughout the study duration.

This research aims to verify the accuracy, stability, and clinical usefulness of artificial intelligence (AI) algorithms for measuring heart function through echocardiography. The study involves collaboration with multiple medical centers and focuses on comparing AI measurements with those done manually by physicians of different experience levels. It also explores whether AI can reduce the time needed for echocardiogram analysis and improve clinical workflows, while assessing AI's performance in complex heart conditions such as cardiomyopathy and valve disease. The study collects echocardiographic data using Mindray ultrasonic machines, with AI and physicians at each center measuring key heart parameters including left and right ventricular size and function. AI and intermediate doctors complete measurements within one day of data collection, while senior physicians at the main research unit finalize their assessments within one month. The goal is to establish a standardized reference system for AI in ultrasound measurement and promote its use across various medical institutions. Participants aged 18 to 80 years with specific heart conditions or normal hearts are involved. Researchers measure heart chamber sizes and functions through echocardiography, comparing AI and physician results for consistency and accuracy. The study also monitors how AI-assisted measurements could optimize diagnosis time and medical resource use. The total duration of participant involvement depends on data collection and measurement timelines, with ongoing analysis to support AI's clinical application in cardiovascular care.

Researchers are conducting a first-in-human Phase I clinical trial to assess TQB3122 Capsules, a PARP1-targeted inhibitor, in adults with advanced malignant solid tumors. The study aims to evaluate the safety, tolerability, and how the drug moves through the body, while also exploring its preliminary effectiveness in treating various advanced cancers such as ovarian, breast, and prostate cancers. Participants will receive TQB3122 Capsules during the study. The trial includes a dose escalation phase where doses are adjusted to find the maximum tolerated dose and a dose expansion phase for further evaluation. Each treatment cycle lasts 28 days, and the study monitors for dose limiting toxicities and establishes a recommended Phase II dose over a period that can extend up to 24 months. During the trial, participants will undergo regular assessments including physical exams, laboratory tests, and imaging to monitor safety, drug effects, and tumor response. Researchers will track adverse effects and overall health status, ensuring participants meet performance and survival criteria. The total study duration includes baseline assessments and follow-up to evaluate long-term safety and efficacy 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 evaluating the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) with or without durvalumab compared to the investigator's choice chemotherapy combined with pembrolizumab in patients who have PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC). This Phase III, randomized, open-label, international study aims to see if adding durvalumab to Dato-DXd can help patients live longer without their cancer worsening or simply live longer compared to standard chemotherapy with pembrolizumab. The study also examines how the treatments and cancer impact patients' quality of life. Participants will be randomly assigned to one of three treatment groups: Dato-DXd plus durvalumab, Dato-DXd alone, or investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin) combined with pembrolizumab. All treatments are given by intravenous infusion. The study design includes stratification based on geographic location, disease-free interval history, and prior PD-1/PD-L1 treatment for early-stage TNBC. During the study, participants will have regular assessments to monitor their disease status using RECIST 1.1 criteria and undergo imaging reviewed by blinded independent central review. Researchers will track progression-free survival, quality of life, safety, and other health measures over an anticipated period of up to 33 months. Participants must provide tumor samples for PD-L1 testing, and safety monitoring will continue throughout the study.

Researchers are evaluating zorifertinib as a first-line treatment in patients with advanced non-small cell lung cancer (NSCLC) that has mutations in the epidermal growth factor receptor (EGFR) and has spread to the central nervous system (CNS). This study is a patient-centered, multi-center, prospective trial designed to assess the survival benefits and safety of zorifertinib compared to other EGFR tyrosine kinase inhibitors (EGFR-TKIs) for these patients. Participants in Cohorts A and B will receive zorifertinib as their first treatment. The study compares zorifertinib with other anti-tumor treatments used as first-line therapy. Patients in Cohort A must meet specific additional criteria, including no prior treatment with chemotherapy or EGFR-TKIs and stable health conditions. During the study, participants will be monitored for overall survival for up to 36 months. Researchers will assess safety, treatment responses, and clinical outcomes through regular evaluations. Participants will provide informed consent and agree to follow study procedures throughout the treatment and observation periods.

Chronic kidney disease (CKD) includes various conditions that cause damage to the kidneys or reduce their function. CKD affects about 10.8% of the population in China, making it a major health concern due to its high prevalence and associated risks, including progression to kidney failure and increased cardiovascular problems. This study aims to better understand CKD in China by investigating its occurrence, progression, treatment, and related risk factors using real-world patient data from multiple centers. The research is a multi-center, prospective, observational study involving a large and diverse group of participants from mainland China. It uses a standardized data network for efficient collection and analysis of patient information. The study includes people diagnosed with CKD, those at risk due to conditions like hypertension or diabetes, and healthy individuals, allowing for broad and detailed analysis. The study does not involve specific treatments but focuses on observing patients over time. Participants will be followed for up to 5 years to monitor the development or progression of CKD and related health outcomes. Researchers will collect and analyze clinical data and track kidney function and disease status over this period. This long-term observation aims to provide valuable insights into CKD prevention and management, helping to reduce the disease burden in China.