Shao Yang Shi

Researchers are evaluating the safety and effectiveness of HLX22 combined with trastuzumab and chemotherapy as the first treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 2, double-blind, randomized, and multiregional study compares this combination against trastuzumab and chemotherapy with or without pembrolizumab. The study aims to measure how well the treatments work in controlling the disease and improving survival for up to five years. Participants will be randomly assigned to one of two groups. One group receives HLX22 at 15 mg/kg every three weeks along with trastuzumab, chemotherapy (XELOX regimen), and possibly a placebo for pembrolizumab. The other group receives a placebo for HLX22 plus trastuzumab, chemotherapy (XELOX), and possibly pembrolizumab every three weeks. Treatment continues until the disease worsens, unacceptable side effects occur, withdrawal of consent, or other protocol-specified reasons. Throughout the study, participants will undergo regular assessments including tumor scans reviewed by an independent committee to evaluate progression-free survival and overall survival over up to five years. Other evaluations include safety monitoring and organ function tests. The study tracks how long patients live without disease progression and overall survival, aiming to better understand the benefits and risks of HLX22 combined with current standard treatments.

Researchers are evaluating the safety and effectiveness of 9MW1911 in people with Chronic Obstructive Pulmonary Disease (COPD) through a Phase II, multicenter, double-blind, randomized, placebo-controlled clinical trial. The study focuses on patients aged 40 to 75 years who have a history of moderate to severe COPD exacerbations and moderate-to-severe COPD lung function impairment. This trial aims to compare 9MW1911 to a placebo to better understand its impact on COPD symptoms and exacerbations. Participants will be assigned to receive either intravenous 9MW1911 or a placebo every 28 days. The treatment period lasts 52 weeks, during which the study drug is administered monthly. The trial includes careful monitoring and evaluation of the participants' lung function and health status throughout this time to assess the effects of the treatment. During the study, participants will undergo various assessments including lung function tests and monitoring for COPD flare-ups or exacerbations. The primary outcome measured is the annual rate of moderate to severe acute COPD exacerbations over 52 weeks. Safety evaluations and regular health checks will also be conducted to ensure participant well-being. The total duration of participation in the trial is one year, providing comprehensive data on treatment effects and safety.

Researchers are evaluating the safety and effectiveness of giving tirofiban early to patients who have received tenecteplase for acute ischemic stroke. This phase 3 study addresses the problem of reocclusion that happens in 14-34% of patients after thrombolysis, likely due to platelet activation. The goal is to see if adding tirofiban soon after tenecteplase can reduce this risk and improve patient outcomes. Participants will be randomly assigned to receive either a continuous intravenous infusion of tirofiban or a placebo. The infusion starts at 0.3 micrograms per kilogram per minute for 30 minutes, followed by 0.075 micrograms per kilogram per minute for 47.5 hours, beginning within 4 to 24 hours after tenecteplase treatment. Aspirin and/or clopidogrel placebos are given orally 24 hours after tenecteplase, with actual antiplatelet therapy starting at 44 hours and continuing until 90 days after randomization. During the study, participants are monitored for neurological function changes and safety. The main outcome measured is excellent functional recovery 90 days after randomization. The study includes neurological assessments, imaging tests, and laboratory evaluations. Participants are followed for 90 days to observe treatment effects and any adverse events.

Researchers are investigating whether switching to liquefied petroleum gas (LPG) and improving kitchen ventilation can reduce household air pollution from solid fuel use and improve heart and lung health. The study also examines if combining both interventions works better than either alone, their cost-effectiveness, sustainability, and impact on reducing cardiopulmonary events. This is a multi-center, randomized controlled trial involving adults aged 18 to 75 years living in specific village settings. Participants are divided into four groups: one continues using solid fuels without ventilation; one uses LPG without ventilation; another uses solid fuels with ventilation facilities; and the last group uses both LPG and ventilation. During the 12-month intervention, LPG stoves and ventilation equipment are provided as appropriate, along with regular supplies like LPG fuel and electricity cost compensation. After 12 months, the group without initial intervention receives free LPG stoves and ventilation equipment. Participants will be monitored over one year, with follow-up assessments at 6, 12, 24, and 36 months. Researchers will measure changes in ultrafine particles, fine particulate matter (PM2.5), heart rate variability through ECG, and lung function tests such as forced vital capacity and forced expiratory volume. The study includes regular health education and tracks adherence to cooking practices and ventilation use to assess cardiopulmonary health outcomes and air pollution exposure.

Researchers are evaluating the efficacy, safety, and tolerability of lunsekimig compared with a placebo in adults aged 40 to 80 years who have inadequately controlled Chronic Obstructive Pulmonary Disease (COPD) characterized by an eosinophilic phenotype. This Phase 2b/Phase 3 study focuses on patients with COPD who have specific lung function criteria, prior exacerbations, and blood eosinophil counts, aiming to better manage their condition using a new subcutaneous treatment. Eligible participants will receive subcutaneous injections of either lunsekimig or a matching placebo during a randomized intervention period lasting approximately 48 weeks. The study includes a screening period of up to 4 weeks before treatment and a follow-up period of about 8 weeks after treatment, making the total study duration up to 60 weeks. Participants remain in one of three study arms throughout this timeline. During the study, participants will be monitored regularly to measure the annualized rate of moderate-to-severe COPD exacerbations from baseline up to 48 weeks. Researchers will assess safety, tolerability, lung function, and other health outcomes. The study collects data on participants' lung function, exacerbation frequency, and blood markers, along with adherence to treatment and safety follow-up over the entire study period.

Researchers are investigating the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib to treat women and men with locally advanced or metastatic estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) breast cancer that has an ESR1 mutation. This phase 3 study includes patients who have previously received treatment with ribociclib or palbociclib and aims to evaluate the effectiveness, safety, and tolerability of these treatment combinations. Participants will be randomly assigned to receive either oral lasofoxifene at 5 mg daily combined with oral abemaciclib 150 mg twice a day, or intramuscular fulvestrant 500 mg on specific days followed by monthly doses plus oral abemaciclib 150 mg twice daily. The treatment schedules are designed to compare how well these combinations work in managing the cancer. During the study, participants will be closely monitored for progression-free survival over approximately three years. Researchers will assess the cancer's response to treatment, track any side effects, and evaluate safety and tolerability. Regular evaluations and follow-ups will ensure comprehensive data collection to understand the impact of these therapies on advanced breast cancer.

Researchers are evaluating the effectiveness and safety of adding low-dose radiotherapy to chemoimmunotherapy as a first treatment for patients with nasopharyngeal carcinoma that has spread to the liver. This phase 2 study focuses on patients aged 18 to 70 with confirmed nonkeratinizing nasopharyngeal carcinoma and liver metastasis. The goal is to understand if this combined approach can improve progression-free survival within the liver. The treatment involves delivering low-dose radiotherapy (1.4 Gy daily for 5 days) targeted to liver metastases before starting chemoimmunotherapy. The chemoimmunotherapy regimen includes gemcitabine given on days 1 and 8, cisplatin on day 1, and penpulimab on day 1. This combination aims to assess the safety and therapeutic response in this specific cancer setting. Participants will undergo regular assessments including imaging to measure tumor response, blood tests to monitor organ function and blood counts, and evaluation for side effects. The main outcome measured is intrahepatic progression-free survival at one year. The study includes careful monitoring of safety and drug effects throughout treatment, with follow-up visits to track disease control and patient well-being.

Researchers are evaluating the safety and effectiveness of low-dose tenecteplase in elderly patients who have experienced an acute ischemic stroke. This prospective, multicenter, randomized controlled Phase 4 trial focuses on patients aged 70 years and older who receive treatment within 4.5 hours of stroke onset. The study aims to compare low-dose tenecteplase with the standard dose to understand its impact on stroke recovery in aging patients. Participants are randomly assigned to one of two groups: a low-dose group receiving tenecteplase at 0.175 mg/kg (up to 17.5 mg per patient) or a standard-dose group receiving tenecteplase at 0.25 mg/kg (up to 25 mg per patient). Treatment is administered intravenously as thrombolysis. The trial monitors patients closely to assess how these dosing strategies affect recovery and safety. During the study, researchers will evaluate neurological function using the Modified Rankin Scale 90 days after treatment, measuring the percentage of participants who achieve a score of 0 or 1, indicating no symptoms or no significant disability. Patients will undergo neurological assessments and safety monitoring throughout the trial. The study ensures informed consent and collects relevant clinical data to support its findings on tenecteplase use in elderly stroke patients.

Researchers are evaluating the efficacy and safety of Shuxuening injection as an additional treatment to intravenous thrombolysis in patients with acute ischemic stroke. This multicenter, randomized, double-blind, placebo-controlled phase 3 trial involves patients aged 18 to 100 years who have experienced an ischemic stroke and can be treated within 6 hours of symptom onset. The study aims to improve functional outcomes by reducing brain cell death after stroke using this multi-target neuroprotective agent alongside the standard clot-busting therapy. Participants are randomly assigned in a 1:1 ratio to receive either Shuxuening injection or a placebo. Both groups receive a daily intravenous drip of 20 ml of the study drug or placebo combined with 250 ml of 0.9% sodium chloride injection for 10 to 14 days. The treatment starts as soon as possible after intravenous thrombolysis therapy, and the study compares these two groups to assess differences in recovery and safety. During the trial, researchers will monitor participants for 90 days after randomization. They will assess the primary outcome by measuring the proportion of patients achieving a modified Rankin Scale (mRS) score of 0 to 1, indicating good functional recovery. Safety will be evaluated by tracking adverse events over the same 90-day period. Participants will be closely followed with clinical evaluations to understand the effects and tolerability of Shuxuening injection in stroke recovery.

Researchers are investigating whether emotional distress, such as anxiety or depression, affects how well immunotherapy works in people with liver cancer. The study focuses on three groups: those with liver cancer that cannot be removed by surgery starting immunotherapy, those receiving immunotherapy after surgery, and those receiving immunotherapy before surgery. Emotional distress will be assessed using questionnaires and clinical evaluations to understand its influence on treatment response and survival. Participants will receive standard immunotherapy as recommended by their doctors. Emotional distress will be measured through self-reported tools like PHQ-9 and GAD-7, and clinician-rated scales including the Hamilton Depression and Anxiety Scales. Assessments occur before treatment, after 2-3 therapy cycles, and every three months during follow-up. Blood tests will be done regularly to measure stress hormones alongside quality of life questionnaires. Throughout the study, participants will have regular medical check-ups and scans to monitor cancer status. Researchers will track progression-free survival up to 24 months, disease-free survival up to 36 months, and pathological complete response at surgery time, about 6-8 weeks after neoadjuvant therapy. The study lasts up to three years, aiming to identify links between emotional health and immunotherapy outcomes while providing access to mental health support if needed.