Yun Cheng 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 effectiveness and safety of a new drug called TQB2102 for Injection compared to a combination treatment of docetaxel, trastuzumab, and pertuzumab in adults with HER2 positive recurrent or metastatic breast cancer. This Phase III trial involves multiple centers and randomizes participants into two groups to compare these treatments. The study aims to better understand how well TQB2102 works and its safety profile in this patient population. Participants receive treatments through intravenous infusions every 21 days. One group is treated with TQB2102, a next-generation HER2 Antibody-Drug Conjugate, while the other group receives docetaxel combined with trastuzumab and pertuzumab following specific dosing schedules. Docetaxel is given once every three weeks for six cycles, trastuzumab starts with a loading dose followed by maintenance doses every three weeks, and pertuzumab is administered with an initial loading dose followed by maintenance doses every three weeks with observation after infusions. The study compares these two treatment approaches over the course of the trial. During the study, participants will undergo regular evaluations including imaging to assess tumor response, blood tests to monitor drug levels and immune responses, and tracking of any side effects or adverse events. The primary outcomes measured are the objective response rate and progression-free survival up to about 30 months. Secondary outcomes include overall survival, duration of remission, and detailed safety assessments up to around 52 months. The study also involves monitoring specific antibodies related to the drug and other laboratory markers to understand treatment effects fully.

Researchers are comparing the safety and effectiveness of a new injection called GR2001 with Human Tetanus Immunoglobulin HTIG for preventing tetanus. This Phase III clinical trial focuses on adults who may have been exposed to tetanus through dirty or contaminated wounds. The study aims to see how well GR2001 works in raising protective antibody levels against tetanus. Participants will be randomly assigned to receive a single intramuscular injection of either GR2001 or HTIG in the gluteal muscle on the first day of the study. GR2001 is provided in a 5mg1ml vial with specific packaging materials, while HTIG is a licensed human plasma-derived immunoglobulin. Both treatments are given once, and the study is designed as a double-blind trial. During the trial, researchers will monitor the increase in anti-tetanus antibody levels up to 12 hours after injection and follow participants for up to 105 days to observe the occurrence of tetanus and assess safety. They will also evaluate how GR2001 behaves in the body, including its peak concentration and overall exposure. Participants will undergo assessments and safety monitoring throughout this period to gather comprehensive data on the treatment effects.

Researchers are evaluating the protective effects, safety, and immune response of an 11-valent recombinant human papillomavirus HPV vaccine in Chinese women aged 18 to 45 years. This Phase III clinical trial involves 13,500 women divided into three age groups to assess the vaccines ability to prevent HPV infections and related cervical lesions. Participants are randomized into experimental and placebo groups to compare outcomes. The trial administers three doses of either the HPV vaccine or a placebo via intramuscular injections into the upper arm deltoid muscle, scheduled at 0, 2, and 6 months. The study uses a double-blind design to ensure unbiased results. The vaccine targets multiple HPV types associated with cervical cancer and related conditions. Participants will undergo follow-up visits including gynecological examinations, pregnancy testing, and monitoring for adverse events. Researchers will measure the incidence of cervical intraepithelial neoplasia CIN and HPV-related lesions, as well as antibody responses at multiple time points after vaccination. The trial includes long-term monitoring up to six years to evaluate vaccine safety and effectiveness.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the effectiveness, safety, and tolerability of elecoglipron alone or combined with dapagliflozin compared with a placebo in adults with type 2 diabetes mellitus T2DM who are not adequately controlled by lifestyle management alone or who are on other background glucose-lowering medications. This Phase III study aims to understand how these treatments impact blood sugar control and related health factors. Participants will be randomly assigned to one of four groups elecoglipron at dose level 1 with dapagliflozin-matched placebo, elecoglipron at dose level 2 with dapagliflozin-matched placebo, a combination of elecoglipron at one of the studied doses with dapagliflozin, or matching placebos for both drugs. All treatments are taken orally once daily. The study uses a quadruple-blind design to compare these options over a treatment period lasting up to 40 weeks. During the study, participants will have their blood sugar levels measured by changes in Hemoglobin A1c HbA1c from baseline to week 40. Other assessments include body weight, blood pressure, and the time to start any additional rescue medication. Participants will attend regular visits for monitoring and safety evaluations throughout the study duration, which extends until the primary completion date in July 2028.

Researchers are conducting a prospective, multi-center observational study in China to better understand drug-induced liver injury DILI. The study aims to explore the clinical features, identify the drugs or herbs causing DILI, assess patient outcomes, and discover new serum markers. The goal is to develop and validate a prognostic model incorporating these novel markers to improve prediction of patient prognosis in China. Participants will be grouped into a modeling group to help build a predictive model for DILI outcomes, and a validation group to test the accuracy of this model. The study collects long-term data to establish and verify these prognostic tools. No experimental treatments are given as this is an observational cohort study. During the study, researchers will monitor participants for key outcomes such as death, liver transplantation, and acute liver failure over one year, as well as chronic DILI and recovery over two years. Data will be collected through regular clinical assessments and laboratory tests. This long-term follow-up will help improve understanding of DILI prognosis and validate new serum biomarkers. Participants will be involved over extended periods to ensure comprehensive outcome measurement.

Researchers are evaluating the combined use of vicadrostat and empagliflozin in adults with chronic heart failure who have a reduced left ventricular ejection fraction LVEF below 40%. Participants must have had chronic heart failure diagnosed at least three months before starting the study. The trial aims to find out if this combination helps people with symptomatic heart failure classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups, with an equal chance of receiving either vicadrostat plus empagliflozin tablets or placebo plus empagliflozin tablets. The study medicines are taken once daily for approximately six months up to about 3.5 years. During this time, participants may continue their usual heart failure treatments, excluding certain medications. The trial includes a double-blind design, meaning neither participants nor study staff know who receives the active drug or placebo. Throughout the study, participants visit the study site regularly, with the number of visits depending on how long they stay enrolled. Some visits may occur by phone. They answer questions about their well-being, and doctors monitor health status, record any heart failure worsening, hospitalizations, or deaths. The main outcome is the time until cardiovascular death, heart failure hospitalization, or urgent heart failure visit, which is compared between groups. Safety and side effects are also closely followed during the trial.

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.

Researchers are studying the efficacy and safety of combining LM-302 injection with tislelizumab compared to tislelizumab plus chemotherapy for patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma that tests positive for CLDN18.2. This Phase III trial focuses on patients who have not been previously treated systemically for this cancer type and aims to understand if the new combination improves outcomes. Participants are randomly assigned to one of two study groups one receiving LM-302 injection with tislelizumab in 14-day treatment cycles, and the other receiving tislelizumab combined with oxaliplatin injection and capecitabine tablets in 21-day cycles. The trial is open-label, meaning both participants and researchers know which treatment is given. The study treatment period extends until disease progression or other discontinuation criteria are met. During the study, participants undergo regular assessments including imaging to measure progression-free survival, overall survival, tumor response rates, and adverse events over up to two years. Laboratory tests, tumor tissue analyses, and physical performance evaluations are conducted to monitor safety and treatment effects. Women of childbearing potential and men must use effective contraception during and after treatment. The entire study participation lasts until the primary outcome measure is reached or the study ends in May 2030.