Yang Zhou Shi

Researchers are evaluating the efficacy and safety of a drug called B007 compared to Cyclosporin in treating Primary Membranous Nephropathy, a kidney condition confirmed by biopsy. This study is a multicenter, randomized, controlled, open-label trial in phase II/III, focusing on patients aged 18 to 80 years with certain kidney function levels and proteinuria. Participants will receive either B007 via subcutaneous injections on days 1 and 15 or oral Cyclosporin capsules dosed at 3.5 mg per kg per day. The study includes screening to confirm eligibility, treatment administration, and monitoring for approximately two years to evaluate overall remission rates. Throughout the trial, participants will be monitored with laboratory tests to meet study standards and ensure safety. Researchers will assess kidney function, protein levels in urine, and remission rates over about two years. Safety will be followed closely, including checking for allergies, infections, and adherence to the treatment protocol.

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 the effectiveness and safety of TQB6411 for Injection in adults with advanced lung cancer. This clinical trial is designed as a Phase Ib/II study to determine the recommended Phase II dosage and to observe the objective response rate over a period of up to six months. Participants must have confirmed lung cancer with measurable lesions and meet specific health and laboratory criteria to be eligible. The treatment involves administering TQB6411 for Injection every 21 days as a cycle. The study focuses on monitoring the drug’s safety and how well it works in treating advanced lung cancer. Participants will receive this treatment while being closely observed for any side effects or responses to the therapy. During the study, participants will undergo various assessments including laboratory tests, tumor tissue sampling for immunohistochemical testing, and regular health evaluations. The main outcomes measured are the recommended dosage for Phase II and the cancer's response to treatment over six months. Participants will be monitored for safety and treatment effects throughout the study period, which includes initial treatment and follow-up assessments.

Researchers are evaluating a combination treatment using BNT326 and BNT327 in adults with advanced or metastatic non-small cell lung cancer (NSCLC), including those with relapsed, progressive, or treatment-nafve disease. This multi-site, open-label study includes dose-finding and dose-expansion phases to investigate the safety, tolerability, and preliminary effectiveness of this combination therapy. The study targets patients whose tumors are advanced, metastatic, or recurrent with no curative treatment options available and includes participants with different genomic alterations. The study is divided into several parts: Part 1 is a dose escalation phase to find safe dose levels of BNT326 with BNT327; Part 2a expands the dose to further evaluate safety and initial efficacy; Part 2b focuses on dose optimization and understanding the contributions of each component. Participants receive intravenous infusions of BNT326 and BNT327, with some cohorts possibly receiving additional treatments such as pembrolizumab or standard chemotherapy. Treatment continues until disease progression, unacceptable side effects, withdrawal, or a maximum of 24 months. Dose levels for certain cohorts are determined based on earlier phase data, and some parts include randomization to different treatment groups. Participants undergo a screening period before starting treatment, followed by treatment, safety follow-up, efficacy follow-up, and long-term survival monitoring, totaling about 36 months. Researchers assess dose-limiting toxicities within the first 21 days of treatment and monitor adverse events, treatment interruptions, and objective response rates up to 36 months. Tumor measurements, safety labs, imaging, and patient health status are regularly evaluated. The study tracks tolerability and efficacy while ensuring participant safety throughout treatment and follow-up.

Researchers are conducting a large community-based cohort study in Yangzhou to evaluate the effectiveness of polygene methylation detection for colorectal cancer screening. This study involves a prospective group of 80,000 permanent residents aged 40 to 74 years and is planned over a 5-year period. The goal is to verify real-world results of this screening method by comparing it with colonoscopy and pathological examination outcomes, focusing on sensitivity, specificity, and detection rates of precancerous lesions and adenomas. Participants will complete a colorectal cancer risk factor questionnaire and undergo polygene methylation testing at baseline. Those who test positive will have additional tests including fecal immunochemistry (FIT), blood carcinoembryo antigen (CEA) tests, and colonoscopy within three months. Follow-up will be done through telephone interviews at 1, 2, 3, 4, and 5 years after baseline to collect medical history and survival outcomes. Patients diagnosed with colorectal cancer or treated for polyps or adenomas during colonoscopy will reach the study endpoint. Throughout the study, researchers will collect detailed data from questionnaires, laboratory tests, colonoscopies, and pathology reports. They will monitor outcomes such as cancer diagnosis and survival while assessing the accuracy and value of the polygene methylation test in the community population. The entire baseline examination phase is expected to be completed within one year.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Researchers are evaluating a multi-modal artificial intelligence (AI) framework designed to improve the classification and genetic profiling of lung cancer using PET/CT imaging and clinical data such as age, gender, smoking history, family cancer history, illness history, and tumor biomarkers. The AI system aims to accurately differentiate small cell lung cancer from non-small cell lung cancer (NSCLC), further classify NSCLC into subtypes like adenocarcinoma and squamous cell carcinoma, and predict genetic mutations such as the EGFR driver gene status commonly found in lung adenocarcinoma patients. This study includes retrospective and prospective patient cohorts for model training, validation, and testing. The intervention involves PET imaging analysis combined with data mining and the development of an AI model to assist in pathological and genetic subtyping of lung cancer. Patients included in the study have undergone a pre-treatment 18F-FDG PET/CT scan and have not received prior anti-tumor treatments or had other malignancies. The AI framework's hierarchical approach stratifies patients through multiple levels, starting with cancer type differentiation, then subtype categorization, and finally genetic mutation prediction. Participants diagnosed with lung cancer will have their clinical and imaging data analyzed to evaluate the AI framework's accuracy over a one-year period, especially in distinguishing between small cell and non-small cell lung cancers. The study monitors outcomes through imaging and pathological data, aiming to improve diagnostic precision. Patient involvement includes scanning procedures, clinical data collection, and follow-up assessments as part of the retrospective and prospective cohorts, ensuring comprehensive evaluation of the AI system's performance.

This research aims to evaluate the effects and safety of ASP5541, a new form of abiraterone acetate given as a muscle injection, in men with advanced prostate cancer. The study focuses on men with metastatic hormone-sensitive prostate cancer (mHSPC) and metastatic castration-resistant prostate cancer (mCRPC), including Japanese men. It compares ASP5541, with or without the steroid prednisone/prednisolone, to the standard oral abiraterone acetate with prednisone/prednisolone. The goal is to see how well ASP5541 works and its safety profile compared to current treatments. Participants are divided into three groups. Group 1 includes men with mCRPC not previously treated with androgen receptor pathway inhibitors (ARPIs), receiving either ASP5541 with prednisone/prednisolone or abiraterone acetate with prednisone/prednisolone. Group 2 includes men with mHSPC not previously treated with ARPIs, receiving either ASP5541 alone or abiraterone acetate with prednisone/prednisolone. Group 3 includes Japanese men with mCRPC or mHSPC who may have prior ARPI treatment, receiving ASP5541 with prednisone/prednisolone. ASP5541 is given as an injection every 12 weeks, prednisone/prednisolone is taken orally once or twice daily depending on cancer type, and abiraterone acetate is taken as daily tablets. All groups continue standard androgen deprivation therapy. During the study, men will visit clinics regularly for health checks, cancer scans, and safety monitoring. Some men in Group 2 will monitor blood pressure weekly at home. Researchers will track prostate specific antigen (PSA) levels, adverse events, vital signs, and lab tests for up to 37 months. The study evaluates how well ASP5541 lowers PSA compared to abiraterone acetate and monitors for side effects and overall health status throughout treatment and follow-up.

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 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.