Lu An Shi

Researchers are evaluating TQB2102 for injection, a new antibody-coupled drug that targets two different parts of the HER2 protein on tumor cells. This study focuses on patients with unresectable locally advanced, recurrent, or metastatic HER2-positive gastroesophageal adenocarcinoma. The trial aims to assess the effectiveness and safety of TQB2102 combined with benmelstobart or penpulimab, with or without chemotherapy, in this patient group. This is a Phase II randomized study sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Participants receive TQB2102 for injection and either benmelstobart or penpulimab, both given intravenously every three weeks. Chemotherapy is taken orally from Day 1 to Day 15 in each 21-day treatment cycle. There are three study groups, each involving different combinations and doses of TQB2102, benmelstobart, penpulimab, and chemotherapy. Treatment continues through multiple cycles as determined by the study protocol. During the study, participants undergo regular assessments including scans and tests to measure tumor response and disease progression. Researchers monitor outcomes like the objective response rate, progression-free survival, duration of response, overall survival, and any adverse events. The study includes follow-up periods to track safety and effectiveness, with an average observation of up to three years. Participants are closely monitored throughout the treatment and follow-up phases for their health and response to therapy.

This trial is for adults who have had an acute ischemic stroke caused by a blood clot blocking a brain vessel. It focuses on people whose stroke occurred or was discovered more than 4.5 hours ago, including those who woke up with stroke symptoms. The study aims to find out if the medicine tenecteplase helps recovery when given after this 4.5-hour window, compared to standard medical care. Tenecteplase is already used within 4.5 hours after stroke onset, but this study tests its effect when given later. Participants are randomly assigned to one of two groups one receives a single injection of tenecteplase into a vein, and the other receives the usual standard treatment. Both groups have an equal chance of receiving either treatment. The study lasts about three months, starting with approximately one week of hospital stay. During the study, participants have seven clinical examinations or visits, with the final two visits conducted remotely from home to allow for easier participation. Throughout the study, doctors regularly assess participants recovery using a scale that measures disability and dependence in daily activities. They also monitor overall health and record any side effects. The main outcome measured is the level of recovery 90 days after treatment, comparing the two groups. This includes neurological improvement, bleeding events, and survival over the study period.

Researchers are establishing a standardized clinical database for patients with liver cancer, including hepatocellular carcinoma and related types, to support high-quality real-world clinical studies. This observational study is led by the Department of Hepatobiliary Surgery at the First Affiliated Hospital of the University of Science and Technology of China USTC in collaboration with multiple centers nationwide. The purpose is to collect detailed clinical information to better understand liver cancer outcomes over time. Participants will receive routine clinical treatments for liver cancer, such as surgical resection, ablation, transarterial chemoembolization TACE, hepatic arterial infusion chemotherapy HAIC, and various anti-tumor drugs including immunologic, targeted, and chemotherapy agents. The study observes and records these standard treatments without assigning interventions. The research will track these patients in a cohort database to monitor their treatment and progression. During the study, participants will be followed for up to 10 years to assess overall survival, recurrence-free survival, and survival time after cancer recurrence. Researchers will collect blood and surgical tissue samples and perform regular follow-up visits to gather clinical data and pathology results. This long-term monitoring aims to provide comprehensive insights into liver cancer progression and treatment outcomes.

This research aims to evaluate the safety and effectiveness of TQA2225AP025, 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 assess how well two different doses of this treatment work in managing NASH, a liver condition characterized by fat buildup and inflammation. Participants will receive either 25mg or 50mg of TQA2225AP025 or a matching placebo, given by weekly subcutaneous injections for 48 weeks. The study includes two experimental groups receiving the different doses, and all treatments are administered under blinded conditions to assess the treatment effects accurately. During the study, participants will undergo liver biopsies at the start and after 48 weeks to measure changes in liver condition using the NASH CRN scoring system. Safety will be closely monitored by tracking any adverse events throughout the treatment period. The study is expected to provide detailed information on both the treatment impact on liver health and its safety profile over nearly a year of participation.

Researchers are evaluating intra-arterial thrombolysis as a treatment for adults who have an acute ischemic stroke caused by medium vessel occlusion MeVO or severe artery narrowing. This trial aims to determine the safety and effectiveness of this treatment compared to standard medical care alone. The study addresses the current lack of strong evidence supporting intra-arterial thrombolysis in this specific type of stroke, building on previous trials that showed no clear benefit of endovascular therapy for MeVO. Participants will be randomly assigned to one of two groups. One group will receive the best medical treatment along with intra-arterial thrombolysis using Tenecteplase rhTNK-tPA, administered directly into the artery near the blockage for 5 to 30 minutes. The other group will receive the best medical treatment alone as recommended by stroke care guidelines. The decision to continue thrombolysis beyond the initial 5 minutes is guided by imaging during the procedure. Throughout the study, participants will be monitored for recovery and safety outcomes. The primary measure will be the level of disability 90 days after treatment, using the modified Rankin Scale. Additional assessments include neurological improvements or deterioration within 24 hours and overall functional independence. The trial is designed to carefully track patient progress and adverse events to evaluate the treatments impact over time.

Researchers are evaluating 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. This Phase 3 clinical trial focuses on acute migraine treatment in a pediatric population, aiming to measure pain freedom two hours after dosing and other migraine-related symptoms to understand how well the treatment works in this age group. Participants receive either BHV-3000 rimegepant 75 mg or 50 mg orally disintegrating tablet ODT, or a matching placebo tablet. The study uses a randomized, double-blind design where participants are assigned to one of these groups. The trial monitors the effects of the medication shortly after administration and compares outcomes between the active drug and placebo groups. During the study, participants will be assessed for pain relief, freedom from the most bothersome migraine symptoms, and need for rescue medication within 24 to 48 hours after treatment. Researchers will also evaluate sustained pain freedom and the ability to function normally following the migraine attack. Various outcome measures include pain and symptom assessments at 2 hours post-dose, along with tracking medication use and migraine impact. The trial lasts until the primary completion date in January 2029, with ongoing safety and efficacy monitoring throughout.

Researchers are evaluating the safety and effectiveness of atorvastatin in adults aged 18 to 80 years who have experienced spontaneous intracerebral hemorrhage ICH within 3 to 24 hours of symptom onset. This multicenter, prospective, randomized, open-label, blinded end-point PROBE study aims to determine if atorvastatin improves clinical outcomes compared to best medical treatment alone. The study focuses on patients with hematomas located in the supratentorial region and uses the modified Rankin Scale mRS to measure functional outcomes at 90 days. Participants will be randomly assigned to one of two groups one group will receive atorvastatin 20 mg once daily for 21 days along with best medical treatment BMT following current guidelines for ICH, while the other group will receive only BMT. The treatment period lasts for 21 days starting within 48 hours of symptom onset or last known well time. The study will monitor changes in hematoma and perihematomal edema volumes at specific time points during the first week after hemorrhage. During the trial, participants will undergo assessments including computed tomography CT scans to confirm ICH diagnosis and measure hematoma size, as well as evaluations using the Glasgow Coma Scale and mRS. Researchers will track functional independence and neurological outcomes at 90 7 days. Safety and adverse events will be monitored throughout the study. The total follow-up includes primary and secondary outcome measurements up to three months after treatment to evaluate the impact of atorvastatin on recovery.

Researchers are evaluating the safety and effectiveness of TQC2731 injection in adults with severe asthma that is not well controlled. This is a Phase III clinical trial where 660 participants with asthma are randomly assigned to receive either TQC2731 or a placebo. The study aims to see if TQC2731 can reduce asthma worsening episodes over one year compared to placebo. Participants receive either the TQC2731 injection or placebo every four weeks for up to 48 weeks through subcutaneous injection. The treatment cycles repeat monthly from the start until Week 48. The study compares these two groups to assess the impact on asthma symptoms and lung function. Throughout the trial, participants will have regular assessments including lung function tests, asthma symptom diaries, quality of life questionnaires, and blood tests for inflammation markers and immune response. Researchers track the number of asthma exacerbations during the 52 weeks of treatment and up to 64 weeks for some outcomes. Safety and immune reactions are monitored carefully. The total study duration for each participant is about one year of treatment plus follow-up.