Ngawa Tibetan And Qiang Autonomous Prefecture

Researchers are studying the safety and effectiveness of T3011, a herpesvirus injection, combined with PD-1PD-L1 inhibitors in adults with advanced solid tumors. This clinical trial aims to evaluate how well this combination treatment works and how well patients tolerate it, with the study sponsored by Shanghai Pharmaceuticals Holding Co., Ltd. It is a Phase IbIIa trial conducted at multiple centers. Participants will receive T3011 injected directly into tumors every two weeks, along with PD-1PD-L1 inhibitors given by intravenous infusion at a dose of 3 mgkg also every two weeks. Different dose levels of T3011 high, middle, and low are being tested to assess safety and initial effectiveness. The study does not include a placebo group and is open-label, meaning both researchers and participants know the treatments being given. During the study, participants will be closely monitored for side effects and treatment responses over about two years. Researchers will measure outcomes such as the rate of treatment-related adverse events, objective response rate, disease control rate, duration of remission, progression-free survival, and overall survival. Participants will undergo regular assessments including physical exams, laboratory tests, and imaging to track their progress and safety throughout the trial.

Researchers are evaluating the safety and effectiveness of Pimicotinib ABSK021 combined with chemotherapy, with or without the addition of Toripalimab, in patients with advanced pancreatic cancer. This phase II, open-label study aims to understand how well this combination works and how safe it is for people with non-resectable local advanced or metastatic pancreatic cancer. The study is sponsored by Abbisko Therapeutics Co, Ltd and focuses on patients who have not received prior systemic treatment for pancreatic cancer. Participants receive Pimicotinib orally once daily along with chemotherapy drugs Gemcitabine and nab-Paclitaxel given by intravenous infusion on days 1 and 8 of each 21-day cycle. In one group, Toripalimab is also given intravenously on day 1 of each cycle. Treatment lasts about 24 weeks, covering approximately eight cycles. The study includes two cohorts in both parts A and B to compare the combination with and without Toripalimab. During the study, participants undergo assessments to monitor safety events from the day they consent until 90 days after completing eight cycles, as well as evaluations of tumor response. Researchers also track the duration of response, progression-free survival, overall survival, and drug levels in the blood during the treatment period. Participants complete all study procedures as outlined by the researchers, who guide them through the process to evaluate the treatments effects over time.

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 efficacy and safety of a new drug called STN1013800 ophthalmic solution for treating acquired blepharoptosis in Chinese patients. This condition involves drooping of the upper eyelid, and currently, there are no approved medicines for this in China. This is a Phase III randomized, double-masked, placebo-controlled study designed to compare STN1013800 with a placebo solution. Participants will receive either 0.1% STN1013800 ophthalmic solution or a placebo once daily for 42 days, based on prior clinical trial results. The study includes a screening period lasting 3 to 7 days to confirm eligibility. The interventions involve applying the assigned eye drops daily, with the study treatment and placebo groups monitored in parallel. During the study, participants will undergo multiple assessments including margin reflex distance-1 MRD-1 measurements and Leicester Peripheral Field Test LPFT scores at several time points Day 1 Hour 6, Day 14 Hour 2, and Day 42. Researchers will track changes from baseline in eyelid position and visual function to evaluate treatment effects. Safety and adherence will also be monitored throughout the 42-day treatment period.

This research aims to evaluate the safety and effectiveness of combining selinexor with azacitidine and venetoclax in adults newly diagnosed with acute myeloid leukemia AML who have not received prior treatment. The study is a prospective, single-arm, multi-center clinical trial focusing on patients who are either ineligible for or refuse intensive chemotherapy. It is designed to gather data on how well this combination works and its safety profile in this patient group. Participants will receive selinexor orally at 60 mg on days 3, 10, and 17 azacitidine intravenously at 75 mgm2 on days 1-3, 8-9, and 15-16 and venetoclax orally starting at 100 mg on day 1, increasing to 200 mg on day 2, and 400 mg on days 3-14 within each 28-day treatment cycle. Those who achieve complete remission may undergo a transplant at any time, while others will continue treatment until the disease progresses or unacceptable side effects occur. During the study, participants will be closely monitored for treatment response and safety through assessments including remission rates up to about two years. Secondary measures include overall survival, response rates, minimal residual disease negativity, and recurrence-free survival over approximately four years. The total participation time varies based on individual outcomes, with ongoing evaluations to track effectiveness and side effects throughout the study period.

Researchers are evaluating the safety and effectiveness of Autologous Tumor Infiltrating Lymphocytes GT101 injection compared with Gemcitabine in women with recurrent or metastatic cervical cancer. This Phase II study is conducted at multiple centers and involves random assignment to one of two treatment groups. It aims to provide important information about these treatments for patients who have already received prior systemic therapy for this cancer. Participants will receive either GT101 injection, a biological treatment derived from the patients own tumor cells, or Gemcitabine injection, a chemotherapy drug. The study is open-label, meaning both the participants and researchers know which treatment is given. Treatments are administered according to the study protocol and monitored for effects over time. During the study, women will undergo regular assessments to evaluate disease progression, treatment response, and safety. This includes imaging scans measured by RECIST 1.1 criteria and monitoring for side effects using standardized criteria. The main outcome measured is progression-free survival over three years, along with duration of response and treatment-related adverse events. Participants will be followed for up to three years to track these outcomes.

This research aims to evaluate whether MM09, a sublingual immunotherapy, can help patients aged 12 to 65 with moderate-to-severe allergic rhinitis or rhinoconjunctivitis caused by house dust mites, with or without mild to moderate asthma. The trial is a phase III, randomized, double-blind, placebo-controlled study designed to assess if MM09 reduces symptoms and the need for rescue medications, while also monitoring safety. Participants will receive either the active MM09 sublingual spray or a placebo solution without the active ingredient. The treatment is given daily over 12 months. The study carefully compares the effects of MM09 against placebo to understand its impact on allergic rhinitisrhinoconjunctivitis and asthma symptoms. During the study, participants will record symptoms and medication use via a smartphone app. Researchers will measure combined symptom and medication scores, as well as separate scores for rhinitis, rhinoconjunctivitis, and asthma symptoms and medication intake during the last four weeks of treatment. Safety and any medical problems from inhaling MM09 will be closely monitored throughout the trial, which lasts up to 12 months.

Acute myocardial infarction AMI, especially ST-segment elevation myocardial infarction STEMI, remains a leading cause of death worldwide despite advances in reperfusion treatments. Mortality rates remain significant even when primary percutaneous coronary intervention pPCI is timely administered, and many survivors develop heart failure. This trial explores the role of leukotriene C4 LTC4 in myocardial ischemia-reperfusion injury IRI and investigates montelukast, a leukotriene receptor antagonist, as a potential therapy to reduce heart damage and improve outcomes in STEMI patients undergoing pPCI. Participants will be randomly assigned to receive either montelukast at a dose of 10 mg daily or a placebo for three months following enrollment. The study is triple-masked, meaning that participants, care providers, and researchers do not know which treatment is given. The treatment period aims to assess the effects of montelukast on heart protection after the acute myocardial event. Throughout the study, participants will be monitored for changes in left ventricular remodeling over 24 weeks from enrollment to the end of treatment. The trial includes assessments of heart function and structure, with cardiac magnetic resonance imaging used to evaluate outcomes. Safety and tolerance of the treatment will also be observed, and patient progress will be followed up during the 6-month study period to measure cardiac function and remodeling improvements.

Researchers are evaluating a standardized full-course extracorporeal membrane oxygenation ECMO management pathway for adults with moderate-to-severe acute respiratory distress syndrome ARDS in China. The study aims to address challenges in ECMO care, such as inconsistent clinical practices, low weaning success, and high complication rates. It focuses on creating a reproducible and evidence-based management strategy to improve the quality and outcomes of ECMO treatment nationwide. The study includes developing a multidisciplinary consensus-based ECMO management pathway covering all stages from assessment and initiation to maintenance, complication prevention, weaning, rehabilitation, and follow-up. Patients treated before pathway implementation receive usual care based on local protocols, while those treated after follow the standardized pathway with individualized adjustments allowed. The study uses a real-world, before-and-after design conducted across multiple centers. Participants undergo ECMO treatment as part of their care, with data recorded on key parameters and deviations from the pathway through an intelligent platform. Regular multidisciplinary reviews analyze outcomes, process barriers, and adverse events to enable continuous pathway improvement. The primary outcome measured is 90-day all-cause mortality after ECMO initiation. Secondary outcomes include mortality at 28 days, liberation from mechanical ventilation, ICU and hospital mortality and length of stay, respiratory support needs, and ECMO-related complications. The study runs from screening through treatment and follow-up with continuous data feedback until February 2030.

Acute respiratory distress syndrome (ARDS) poses a major threat to public health and consumes substantial healthcare resources. Based on the National Hospital Quality Monitoring System (HQMS), our group found that more than 2.5 million patients with ARDS are admitted to intensive care units (ICUs) annually in China, resulting in total hospitalization costs of approximately RMB 29.32 billion. The in-hospital mortality rate is about 39%, which is substantially higher than the international average (12-37%). Extracorporeal membrane oxygenation (ECMO) represents the most important rescue therapy for patients with moderate-to-severe ARDS; however, mortality among ARDS patients receiving ECMO support remains as high as 60%. Therefore, reducing mortality in moderate-to-severe ARDS is essential for achieving the goals of the Healthy China 2030 Initiative. Inflammatory and immune dysregulation occurs in 38.7-70% of patients with ARDS, frequently leading to multiple organ dysfunction. Despite ECMO support, mortality among patients with severe ARDS remains extremely high. Three major challenges contribute to poor outcomes. First, immune dysregulation under ECMO support significantly increases the incidence and mortality of severe complications, while targeted therapeutic strategies based on underlying mechanisms are lacking. Second, the marked heterogeneity of ARDS complicates the identification of optimal timing and modalities of ECMO support. Third, the effects of different invasive mechanical ventilation strategies on lung injury and repair remain poorly understood, and mechanism-guided precision ventilation approaches are still unavailable. Building upon the largest ARDS and ECMO clinical-biological database in China established by our group, this project aims to develop a Chinese precision management strategy for ECMO-supported patients with moderate-to-severe ARDS. 1. Comprehensive characterization of immune spatiotemporal dynamics in moderate-to-severe ARDS is essential for identifying therapeutic targets Current biomarkers reflecting disease progression in ARDS are largely limited to static clinical parameters and single-dimensional measurements, making biomarker-guided precision therapy difficult. Previous studies have identified biomarkers such as soluble receptor for advanced glycation end-products (sRAGE), angiopoietin-2 (Ang-2), and surfactant protein D (SPD) as prognostic indicators, yet these markers provide limited mechanistic insights and have not translated into individualized therapeutic strategies. Our group has established the largest ARDS and ECMO biospecimen cohort in China and has preliminarily characterized the spatiotemporal immune landscape of moderate-to-severe ARDS. We identified VCAM1 and tRF-5004b as potential immune-related targets closely associated with disease progression, providing a solid foundation for the proposed study. 2. Elucidating inflammatory and immune mechanisms underlying severe ECMO-related complications is critical for targeted intervention Among ARDS patients receiving ECMO support, the incidence rates of acute kidney injury (AKI), bleeding/thrombosis, and infection are approximately 45.7%, 40.2%, and 44.7%, respectively. Systemic inflammatory and immune dysregulation is considered a major contributor to these complications, although the underlying mechanisms remain unclear. In addition to the excessive inflammatory response characteristic of ARDS, restoration of oxygen delivery after ECMO initiation may trigger bursts of reactive oxygen species, calcium overload, and endothelial injury, thereby exacerbating inflammation and causing multiple organ dysfunction. Clarifying these mechanisms is essential for developing individualized interventions against severe ECMO-related complications. 3. Establishing multidimensional ARDS subphenotypes provides the basis for precision awake ECMO therapy ARDS is highly heterogeneous with respect to etiology, clinical manifestations, pathophysiology, and molecular characteristics, resulting in variable responses to ECMO support. Conventional classification based on oxygenation or isolated physiological parameters fails to capture the complex biological and immunological evolution of the disease. Our group previously identified hyperinflammatory and hypoinflammatory ARDS phenotypes using multidimensional clinical and biological data, but differences in ECMO responsiveness between these phenotypes have not been systematically investigated. Therefore, comprehensive characterization of ARDS biological heterogeneity and development of an integrated subphenotyping model incorporating clinical, physiological, imaging, and immune molecular features are required to identify patients most likely to benefit from awake ECMO. 4. Deciphering mechanisms of lung injury and repair is crucial for individualized mechanical ventilation strategies Inappropriate mechanical ventilation can exacerbate ventilator-induced lung injury and impair lung repair. Understanding the cellular and molecular mechanisms underlying lung injury and regeneration and clarifying the relationship between ventilatory parameters and tissue stress responses are fundamental to achieving personalized lung-protective ventilation. This project will integrate multimodal imaging, respiratory mechanics, and multi-omics data to characterize the dynamic processes governing lung injury and repair in ARDS, thereby establishing precision mechanical ventilation strategies to enhance lung protection and promote tissue recovery. Perspectives and Expected Impact Focusing on the major challenges in the management of moderate-to-severe ARDS, this project will elucidate the mechanisms responsible for severe complications during ECMO support, establish a multidimensional phenotyping framework to identify patients most likely to benefit from awake ECMO, and decode the mechanisms of lung injury and repair to develop individualized ventilation strategies. Ultimately, this work will provide a comprehensive precision management framework for ECMO-supported ARDS patients, improve the standard of care for moderate-to-severe ARDS in China, and reduce disease-related mortality.