Liao Cheng Shi

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are conducting a Phase 1/2a trial to assess the safety and tolerability of DB-1303/BNT323 in people with advanced solid tumors that express HER2. The study focuses on patients with HER2-positive or HER2-expressing malignant solid tumors that are advanced, unresectable, recurrent, or metastatic, and have not responded to standard treatments or have no available standard treatments. This multicenter, open-label study includes an initial dose-escalation phase followed by a dose expansion phase to explore safety, tolerability, and preliminary efficacy of the treatment.

Bladder cancer, primarily bladder uroepithelial cancer, is a common genitourinary tumor with a high recurrence rate, especially for non-muscle-invasive bladder cancer (NMIBC), which accounts for about 75% of cases. This research evaluates how drug sensitivity testing using patient-derived bladder cancer organoids can guide individualized bladder perfusion chemotherapy to improve treatment selection and reduce recurrence. The study is designed as a multicenter cohort study and aims to compare recurrence-free survival rates among patients receiving organoid-sensitive chemotherapy, organoid-non-sensitive chemotherapy, and BCG therapy. Patients undergo organoid culture from tumor tissue collected during surgery to test sensitivity to several chemotherapeutic agents including gemcitabine, piroxicam, epirubicin, mitomycin, and doxorubicin. Based on organoid drug sensitivity results, patients are assigned to either an organoid-sensitive drug perfusion group or an organoid-non-sensitive drug perfusion group. Chemotherapy regimens include induction perfusion weekly for 4 weeks starting 4 to 8 weeks post-surgery, followed by maintenance perfusion monthly for 11 months. The BCG group receives a series of infusions over one year including induction, booster, and maintenance doses. Participants are closely followed with regular cystoscopy based on their risk level to monitor tumor recurrence and progression over one and three years. Assessments include clinical efficacy evaluations using established criteria and survival analysis to compare recurrence rates. Safety and adverse events are recorded, and data management and quality control measures are applied. The study duration includes treatment, follow-up, and outcome measurement periods up to three years to explore the value of organoid-guided therapy in precision bladder cancer treatment.

Researchers are evaluating the safety and effectiveness of ABP1011T tablets in people with advanced solid tumors, including specific types like small cell lung cancer, esophageal cancer, cervical cancer, bladder cancer, and renal cell carcinoma. This is a multicenter, open-label Phase IIb study that builds on earlier clinical trial results. Priority enrollment is given to patients with small cell lung cancer who have failed at least two prior systemic therapies, as well as other advanced solid tumors in separate groups. Participants receive ABP1011T tablets as continuous treatment in 21-day cycles. Each day, they take one tablet orally on an empty stomach, with water, avoiding food for at least one hour before and after the dose. The study includes multiple groups based on tumor type, with specific criteria for enrollment in each cohort. During the study, participants undergo assessments to measure tumor response for up to about two years. Researchers monitor objective response rate and evaluate safety through clinical evaluations. Participants are expected to comply with study visits and tests, including physical exams and laboratory tests, to track treatment effects and side effects throughout the study period.

Researchers are evaluating the safety and effectiveness of a drug called GB491 combined with Letrozole compared to a placebo combined with Letrozole in treating patients with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer. This study focuses on patients who have not received prior systemic antitumor therapy for this condition. It is a phase III randomized, double-blind, placebo-controlled trial designed to provide important information about treatment options for this group of breast cancer patients. Participants are randomly assigned to one of two groups: one receiving GB491 150 mg orally twice daily plus Letrozole 2.5 mg orally once daily, and the other receiving a placebo orally twice daily plus Letrozole 2.5 mg orally once daily. Treatment cycles last 28 days, starting from the first day of cycle 1. The study compares the combined treatment effects over time, focusing on progression-free survival and safety outcomes. Throughout the study, researchers will monitor participants for progression-free survival using established criteria for about 60 months. They will also assess safety and organ function, with required laboratory tests and clinical evaluations. Participants must meet specific eligibility criteria at the start and provide informed consent. The study aims to gather detailed data on how well the treatments work and their safety profiles over the extended follow-up period.

Researchers are investigating whether Extract of Ginkgo Biloba Leaves Tablets can help improve thinking and memory in people aged 55 years and older who have had an ischemic stroke, which is caused by a blocked blood vessel in the brain. This phase 4 clinical trial is designed to assess both the effectiveness and safety of this treatment when added to the usual care for stroke recovery. Participants must have had a mild stroke confirmed by an MRI scan and show signs of cognitive impairment. The study takes place at multiple hospitals across China. Participants will be randomly assigned to one of two groups: one group will receive Extract of Ginkgo Biloba Leaves Tablets at a dose of 240 mg daily, divided into three doses of two 40 mg tablets each, along with their standard post-stroke care for 52 weeks. The other group will receive only the standard care recommended by the Chinese Stroke Association. The trial is open-label, meaning both the researchers and participants know which treatment is given. Throughout the year-long study, participants will visit the clinic at 4, 26, and 52 weeks after starting treatment for checkups and testing. Researchers will evaluate changes in cognitive function using tests such as the Montreal Cognitive Assessment, Trail Making Test, Symbol Digit Modalities Test, and Verbal Fluency Test. They will also monitor neurological impairment and any new stroke events. Follow-up phone calls will occur at 12 and 38 weeks to support ongoing monitoring and safety assessments.

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.

Primary aldosteronism (PA) is a common cause of secondary high blood pressure, but its best diagnosis and treatment methods are still difficult to establish. This research thoroughly evaluates adrenal venous sampling (AVS), focusing on important clinical, technical, and methodological questions. The goal is to understand how AVS-guided care affects long-term health and biochemical results to improve patient outcomes and management. The study involves patients with PA undergoing adrenal venous sampling through either the antecubital or femoral vein to identify whether aldosterone overproduction is coming from one side or both sides of the adrenal glands. This procedure helps classify the subtype of PA, which guides treatment decisions including potential adrenalectomy. The study also aims to refine AVS protocols and standardize clinical practice. Participants will be monitored for major adverse cardiovascular events (MACE) for one year after the AVS procedure. Researchers will assess clinical and biochemical outcomes to better understand the impact of AVS-guided management on patient prognosis. The study collects detailed information to optimize diagnosis, treatment decisions, and long-term care for individuals with primary aldosteronism.

Researchers are evaluating the effects and safety of the drug TNTL in adults with non-proliferative diabetic retinopathy, a condition affecting the eyes related to diabetes. This Phase III clinical trial compares TNTL to a placebo to determine if TNTL can improve visual clarity and reduce the severity of retinopathy. The study also aims to identify any medical issues participants may experience while taking TNTL. Participants will take either TNTL or a placebo orally, four tablets three times a day after meals, for 24 weeks (6 months). They will visit the clinic every 4 weeks for checkups and testing during the treatment period. The study includes two groups: one receiving TNTL and the other receiving a placebo designed to look like TNTL. During the study, participants will keep a diary of symptoms and changes. Researchers will measure the change in best corrected visual acuity (BCVA) from the start of the study to the end of treatment at 24 weeks. Regular assessments and safety monitoring will be conducted throughout the 6-month treatment period to evaluate both effectiveness and safety.

Researchers are investigating the safety and effects of stopping oral anticoagulation treatment after successful catheter ablation in adults with atrial fibrillation or atrial flutter. The study enrolls adults aged 18 to 80 years who are between 60 and 365 days post-ablation, have a CHA2DS2-VA score of 2 or higher, no history of stroke or embolism, and no recurrence of atrial tachyarrhythmia. The goal is to evaluate whether stopping anticoagulation reduces bleeding risk without increasing the risk of death, stroke, or systemic embolism. Participants will be randomly assigned to one of two groups: either to stop their non-vitamin K antagonist oral anticoagulant (NOAC) medication immediately or to continue standard NOAC therapy. All participants will use intensified rhythm monitoring with a smartwatch that records single-lead ECGs and scheduled Holter or ECG patch monitoring at least every six months, with encouragement for every two months. If atrial tachyarrhythmia recurrence is detected, participants will exit the study follow-up. During the study, participants will have structured visits at months 3 and 6 after randomization, then every six months, alongside additional rhythm and anticoagulation follow-up every two months. Researchers will monitor for outcomes including all-cause death, ischemic stroke, systemic embolism, and major or clinically relevant bleeding events over 48 months. The study plans to enroll about 4,100 participants to assess safety and outcomes of the anticoagulation discontinuation strategy.