Lu An Shi

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, an antibody-drug conjugate designed to target HER2-expressing tumor cells in patients with relapsed or metastatic breast cancer. This Phase 1/Phase 2 study aims to assess the effectiveness, safety, pharmacokinetics, and anti-drug antibody response of TQB2102 in patients whose cancer has returned or spread and who are not suitable for surgery or radiotherapy. Participants will receive TQB2102 for injection, a HER2 dual-antibody-drug conjugate. The study includes adults aged 18 to 75 years with HER2-positive breast cancer that has progressed after previous treatments. Female participants of childbearing age must use contraception during and for six months after the study, and male participants must also agree to use contraception during this period. Treatment dosing schedules and administration details are provided within the study protocol. Throughout the study, researchers will monitor participants from baseline up to 10 months to evaluate the overall response rate to the treatment. Assessments include physical exams, laboratory tests, imaging to measure tumor response, and safety evaluations. Participants will be followed closely for adverse effects and treatment response to understand the drug's impact and tolerability over time.

Researchers are evaluating whether the medicine tenecteplase helps adults recover from an acute ischemic stroke when given more than 4.5 hours after they were last seen well. This study focuses on people who had a stroke caused by a clot blocking blood flow in the brain and who have imaging showing brain tissue that can still be saved. Participants should not be planning to receive a procedure to remove the clot and must have a pre-stroke disability level of 0 or 1 on the modified Rankin Scale. Participants are randomly placed into two groups. One group receives a single injection of tenecteplase into a vein, while the other group receives standard medical care. The study includes adults aged 18 and over who had an acute stroke or woke up with stroke symptoms more than 4.5 hours ago. Imaging with MRI or CT is used to confirm eligibility. The study lasts about three months, starting with a hospital stay of about one week. During the study, participants have seven clinical examinations or visits to monitor their recovery and health. The last two visits may be done from home to allow remote assessments. Researchers use the modified Rankin Scale to measure disability or dependence in daily activities at 90 days after treatment. They also monitor for any side effects or health changes to compare the effects of tenecteplase against standard care.

Researchers are establishing a standardized clinical information database for liver cancer patients through a collaborative effort led by the Department of Hepatobiliary Surgery at the First Affiliated Hospital of the University of Science and Technology of China (USTC). This database aims to support high-quality real-world clinical studies and research on hepatocellular carcinoma and related liver cancers. Participants may receive routine treatments such as surgical operations including resection, ablation, transarterial chemoembolization (TACE), and hepatic arterial infusion chemotherapy (HAIC). They might also be treated with various anti-tumor drugs including immunologic, targeted, and chemotherapy medications. Treatments and clinical data are collected to enrich the database for future research. During the study, participants will provide blood samples and postoperative pathology residual samples and will be followed over time to monitor their health and treatment outcomes. The primary outcome measured is overall survival over 10 years. Participants must be willing to comply with follow-up visits and provide informed consent, ensuring comprehensive data collection for long-term analysis.

This trial investigates the effects of TQA2225/AP025, a recombinant human FGF21-Fc fusion protein, in adults with Non-Alcoholic Steatohepatitis (NASH). It is a randomized, double-blind, placebo-controlled Phase II study designed to evaluate the safety and effectiveness of two different doses (25mg and 50mg) of this drug compared to a placebo. Participants have a confirmed diagnosis of NASH based on liver biopsy and imaging, and the study aims to assess changes in liver health over time. Participants receive either 25mg or 50mg of TQA2225/AP025 or a matching placebo, and the treatment is administered during the study period. The trial compares the impact of these doses on liver fibrosis and inflammation, as measured by liver biopsy scores and imaging results. The study includes a treatment duration of 48 weeks, during which the drug's effect on liver tissue is closely monitored. During the study, participants undergo liver biopsies at baseline and after 48 weeks to evaluate liver changes. Additional assessments include MRI scans to measure liver fat content, laboratory tests to monitor liver enzymes and kidney function, and safety evaluations. Researchers will track participants' adherence to the treatment and monitor any side effects or changes in health status throughout the 48-week period.

Researchers are investigating the effectiveness and safety of intra-arterial thrombolysis for adults who have experienced an acute ischemic stroke caused by medium vessel occlusion (MeVO) or severe stenosis (70% or more). This condition presents a significant clinical challenge, and prior large trials did not show clear benefits of endovascular therapy for MeVO. The RESCUE MeVO trial aims to address the lack of strong evidence supporting the use of intra-arterial thrombolysis in this stroke subtype by conducting a multicenter, prospective, randomized, open-label, blinded end-point study. Participants eligible for this study are adults over 18 years old diagnosed with MeVO or severe stenosis involving specific brain arteries. They will be randomly assigned to one of two groups: one receiving best medical treatment alone, and the other receiving best medical treatment combined with intra-arterial thrombolysis using rhTNK-tPA (Tenecteplase). The thrombolysis involves infusing the medication near the blocked or narrowed artery for 5 to 30 minutes, with dosing adjusted during the procedure. Those who have not received intravenous thrombolysis start at a higher infusion rate than those who have. Throughout the 90-day study period, participants will be closely monitored, with researchers assessing outcomes using the modified Rankin Scale to determine functional recovery. The primary measure of success is an excellent outcome at around 90 days post-treatment, defined as minimal or no disability. Safety and efficacy data will be collected to better understand the role of intra-arterial thrombolysis in treating strokes due to MeVO or severe arterial stenosis.

This research aims to test the safety and effectiveness of BHV-3000 (rimegepant) compared to a placebo for treating moderate to severe migraine attacks in children and adolescents aged 6 to under 18 years. The study focuses on pediatric migraine, including attacks with or without aura, lasting more than 3 hours and occurring 1 to 8 times per month over the previous two months. Participants must be able to clearly distinguish migraine from other headaches and weigh more than 40 kg. Participants will receive either BHV-3000 (rimegepant) at doses of 75 mg or 50 mg as an orally disintegrating tablet (ODT) or a matching placebo. The study is randomized, double-blind, and placebo-controlled, designed to evaluate the acute treatment effect. Some participants may continue stable migraine preventive medications, but use of CGRP antagonist drugs is not allowed. The treatment phase will monitor responses to the study drug during migraine attacks. During the study, participants will be assessed for migraine pain relief two hours after dosing, measuring how many experience complete freedom from pain. Blood samples will be taken, and participants will be monitored for safety and side effects. The study excludes those with certain headache types, significant psychiatric or neurological conditions, recent surgeries, or other serious medical issues that could affect participation or safety. Overall, the study evaluates both the effectiveness and safety of rimegepant in a pediatric population over the course of migraine attacks.

Researchers are evaluating the safety and effectiveness of atorvastatin in adults aged 18 to 80 years who have experienced spontaneous intracerebral hemorrhage (ICH). This multicenter, prospective, randomized, open-label, blinded end-point (PROBE) study plans to enroll 264 patients who arrive within 3 to 24 hours after symptom onset. The goal is to see if atorvastatin can improve recovery compared to standard medical treatment alone. Participants will be randomly assigned to one of two groups: one group will receive best medical treatment according to current ICH guidelines, and the other will receive the same treatment plus atorvastatin at a dose of 20 mg once daily for 21 days. Treatment is started within 48 hours of symptom onset or last known well time. The study focuses on patients with hematomas in the supratentorial brain region, with specific volume and coma scale criteria. During the study, participants will be monitored for functional outcomes, with the primary measure being the proportion of patients who have poor functional recovery at about 90 days, defined by a modified Rankin Scale score of 4 to 6. The study includes assessments through imaging to confirm diagnosis and careful tracking of symptoms and clinical status throughout the treatment and follow-up periods to evaluate safety and efficacy.