Tai An Shi

This trial is investigating the use of TQ05105 Tablets in adults aged 18 to 70 with moderate to severe chronic graft-versus-host disease cGVHD following allogeneic hematopoietic stem cell transplantation. The study aims to evaluate the efficacy and safety of this oral medication, which targets inflammatory and fibrotic processes involved in cGVHD. The trial is open-label and multicenter, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., and conducted as a Phase II clinical study. Participants receive TQ05105 Tablets twice daily in 28-day treatment cycles. The study measures responses up to 48 weeks, including treatment effectiveness and safety outcomes. The primary outcome is the objective response rate at 24 weeks. Secondary outcomes include duration of response, survival rates, incidence of relapse, and adverse events. The study does not involve placebo or blinding. During their participation, patients will be monitored regularly with assessments to track their response to treatment, side effects, and overall health status. Evaluations include laboratory tests and clinical examinations related to cGVHD severity and treatment impact. The total participation period extends up to 48 weeks or more, with ongoing observation for safety and survival measures. Participants will follow a stable medication regimen and adhere to contraceptive measures if applicable.

Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan Dato-DXd with or without Durvalumab compared to investigators choice chemotherapy combined with Pembrolizumab in patients with PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer TNBC. This Phase III, randomized, open-label, international study aims to determine if Dato-DXd with Durvalumab can improve progression-free survival and overall survival while assessing quality of life impacts in this patient population. Participants are assigned to one of three groups Dato-DXd with Durvalumab, investigators choice chemotherapy paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin combined with Pembrolizumab, or Dato-DXd alone. All study drugs are given by intravenous infusion. The study includes stratification by geographic region, disease-free interval, and prior PD-1PD-L1 treatment. Treatment continues with monitoring up to about 33 months for progression-free survival and safety, with some outcomes followed up to 64 months. Throughout the study, participants undergo assessments including imaging to measure tumor response using RECIST criteria, laboratory tests, and questionnaires to evaluate symptoms and quality of life. Researchers monitor time to disease progression, overall survival, response duration, and safety outcomes. Follow-up includes evaluation of subsequent therapies and pharmacokinetics. The total participation duration can be up to several years to capture long-term outcomes.

Bladder cancer is a common and serious tumor that originates from the bladders lining, with the majority being non-muscle invasive bladder cancer NMIBC. NMIBC has a high recurrence rate even after initial treatment, making postoperative bladder perfusion chemotherapy important to prevent tumor return. This research evaluates the use of patient-derived bladder cancer organoids to test drug sensitivities and guide individualized chemotherapy, aiming to improve treatment effectiveness and reduce recurrence for bladder cancer patients. The study involves preparing bladder cancer organoids from tumor tissue collected during surgery. Researchers perform drug sensitivity testing on these organoids with various chemotherapeutic agents, including gemcitabine, pirenzolubicin, epirubicin, mitomycin, and doxorubicin. Based on organoid sensitivity results, patients receive bladder perfusion chemotherapy with either sensitive or non-sensitive drugs, or receive BCG vaccine infusions. Treatment schedules include induction perfusion weekly for 4 weeks and maintenance perfusion monthly for 11 months, or BCG infusions following an induction and maintenance regimen over one year. Participants undergo regular clinical assessments including cystoscopy, urine cytology, and imaging as needed to monitor tumor recurrence and progression over up to three years. Researchers analyze one-year and three-year tumor recurrence-free and progression-free survival rates among groups. The study monitors patient compliance, adverse events, and clinical outcomes to assess the value of organoid drug sensitivity testing in guiding personalized bladder cancer perfusion chemotherapy.

Researchers are evaluating the safety and effectiveness of BGB-16673 compared to pirtobrutinib in adults with relapsed or refractory chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL who have previously been treated with a covalent Bruton tyrosine kinase inhibitor cBTKi. The study is a phase 3, open-label, randomized trial sponsored by BeOne Medicines, aiming to assess treatment options for these patients. Participants are randomly assigned to receive either BGB-16673 or pirtobrutinib, both taken orally. This parallel assignment design compares these two drugs directly. The treatments continue with monitoring up to approximately three years to observe progression-free survival and other outcomes. The study began in September 2025 and is expected to complete in April 2028. During the trial, participants will undergo regular assessments including imaging scans to measure disease status, quality of life questionnaires, and monitoring for adverse events. Outcomes such as overall survival, response rates, duration of response, and time to next treatment are tracked. Safety and quality of life will be evaluated throughout the study period, which may last up to about three years for each participant.

Researchers are evaluating the efficacy and safety of two inhalers, BDA MDI budesonide and albuterol and AS MDI albuterol sulfate, in reducing severe asthma attacks among symptomatic Chinese adults with asthma. This Phase III, randomized, double-blind, multicenter study involves about 1000 participants who have been diagnosed with asthma and continue to experience symptoms despite maintenance therapy. Participants will be randomly assigned to receive either BDA MDI 160180 mcg two puffs of 8090 mcg or AS MDI 180 mcg two puffs of 90 mcg as needed to relieve asthma symptoms or before exercise. The study includes a screening period lasting 14 to 28 days, followed by a treatment period of at least 24 weeks and up to 52 weeks, and concludes with a safety follow-up about two weeks after the last treatment visit. During the trial, participants will attend regular visits to monitor their asthma control and lung function. Researchers will assess the time to the first severe asthma exacerbation, the rate of exacerbations, steroid use, and responses to asthma control questionnaires. Safety will be carefully followed during and after treatment, with the total participation lasting up to approximately one year.

Researchers are evaluating the safety and effectiveness of edaravone dexborneol sublingual tablets for treating cognitive problems after a stroke in adults aged 40 to 80 years. This exploratory Phase II clinical trial is randomized, double-blind, and placebo-controlled, aiming to compare outcomes between patients receiving the study drug and those receiving a placebo. The study focuses on patients who have had an acute ischemic stroke and developed cognitive impairment. Participants will be randomly assigned to receive either edaravone dexborneol sublingual tablets or a placebo twice daily for 24 weeks. Both groups will follow the same treatment schedule over this period. The trial will monitor and compare the safety and effectiveness of the tablet by assessing cognitive function and other health measures. During the study, participants will undergo evaluations including cognitive tests such as the Vascular Dementia Assessment Scale-cognitive subscale, Mini-Mental State Examination, and Montreal Cognitive Assessment at various times up to 24 weeks. Researchers will also track adverse events, treatment discontinuations, and other stroke-related scales. The total follow-up period for safety monitoring extends to 26 weeks, including after treatment completion or early withdrawal.

Researchers are evaluating first-line treatments for adults aged 18 to 75 with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma that cannot be removed by surgery or has spread to distant sites. This Phase II, randomized, open-label, multicenter trial compares a combination of Disitamab Vedotin, Sintilimab, and S-1 with Trastuzumab plus chemotherapy, with or without Sintilimab, to better understand their effects in this condition. Participants will receive either the experimental combination of Disitamab Vedotin 2.5 mgkg IV every 3 weeks, Sintilimab 200 mg IV every 3 weeks, and S-1 40-60 mg twice daily for 14 days every 3 weeks, or the active comparator treatment of Trastuzumab initial dose 8.0 mgkg, then 6.0 mgkg IV every 3 weeks plus chemotherapy drugs such as Oxaliplatin, Capecitabine, 5-FU, or Cisplatin, with or without Sintilimab. Treatments will continue as per the study schedule to assess their effectiveness and safety. During the trial, participants will be monitored for tumor response at 6 months, progression-free survival, overall survival, duration of relief, and disease control rate up to 12 months after the last participant joins. Safety and adverse events will be observed for up to about 2 years. Regular assessments will include clinical exams and imaging to measure tumor changes and treatment effects. The total duration of participation varies based on treatment and follow-up schedules.

Obesity greatly increases the risk of heart failure, and current treatments like caloric restriction, exercise, medications, or surgery may not be suitable for obese patients with heart failure. This research aims to study whether a combined approach using a diet management app and an intelligent weight scale can help obese patients with heart failure and reduced ejection fraction lose weight and improve their heart condition. The trial compares the effectiveness of a fully functional app and scale versus a limited-function version to assess their impact on heart failure outcomes and overall quality of life. Participants are randomly assigned to two groups one using a fully featured diet management app and intelligent weight scale with various monitoring tools and health metrics, and the other using a limited version of both. The full app tracks food intake, exercise, weight, and provides dietary analysis and recommendations, while the full scale measures body composition and vital signs. The limited versions offer fewer features. Participants use the app at every meal and weigh themselves daily for 12 months. During the study, participants will visit the clinic at 12 months for checkups. Researchers will evaluate outcomes such as a composite of death and heart failure hospitalizations over one year, changes in quality of life related to heart failure, and weight change. The trial includes monitoring of heart failure frailty and quality of life assessments at baseline, 3 months, and 1 year, with ongoing safety and condition tracking throughout the study period.

Researchers are evaluating ISM5411, a gut-restricted small-molecule prolyl hydroxylase inhibitor, in adults with active ulcerative colitis. This phase IIa, multicenter, randomized, double-blind, placebo-controlled study aims to assess the safety, tolerability, pharmacokinetics, and clinical efficacy of ISM5411, which may promote intestinal mucosal protection and reduce inflammation. The study addresses limitations of traditional anti-inflammatory treatments for ulcerative colitis. Participants will be randomly assigned to one of several groups receiving either ISM5411 tablets or placebo tablets orally once daily for up to 12 weeks. The treatment groups include three cohorts receiving ISM5411 and one placebo cohort. The study monitors treatment effects and drug levels over this period to understand the drugs behavior and impact. During the study, participants will undergo regular assessments including monitoring of adverse events, vital signs, physical exams, laboratory tests blood, urine, coagulation, and ECGs. Pharmacokinetic measures such as drug concentration and elimination will also be evaluated. Safety follow-up extends to 16 weeks, and the total participation duration covers the treatment and observation periods to ensure thorough evaluation.

Researchers are evaluating the effectiveness and safety of Yangxinshi tablets for patients with chronic coronary syndrome CCS. This is a prospective, multicenter, randomized, open-label, blinded-endpoint clinical trial including 1200 CCS patients. The study is designed to assess exercise capacity and other health outcomes in this population. Participants will be randomly assigned in a 31 ratio to either an experimental group or a control group. The experimental group will receive Yangxinshi tablets three times a day three tablets each time in addition to their basic medication, while the control group will receive only their basic medication. The treatment period for both groups is 24 weeks. During the study, researchers will measure the primary outcome of the 6-minute walking distance 6MWD after 24 weeks of treatment. Secondary outcomes include assessments using the Borg scale and monitoring of major adverse cardiovascular and cerebrovascular events MACCE at multiple time points during treatment. Participants will be monitored for safety and efficacy throughout the 24-week treatment period.