Chi Feng Shi

Researchers are conducting a phase III, randomized, open-label, multicenter clinical trial to evaluate the safety and effectiveness of TQB2102 for injection compared to the chemotherapy regimen TCbHP in the neoadjuvant treatment of patients with HER2-positive breast cancer. The study aims to assess key outcomes including the total physiological complete response (tpCR), breast pathological complete response (bpCR), overall response rate (ORR), event-free survival (EFS), invasive disease-free survival (IDFS), overall survival (OS), and adverse events (AEs). Participants will receive either TQB2102, a HER2 dual-antibody drug conjugate, or the TCbHP chemotherapy combination consisting of Trastuzumab, Pertuzumab, Docetaxel, and Carboplatin. Treatment is given before surgery as part of the neoadjuvant approach. The study compares these two treatment regimens to determine their relative effectiveness and safety in this setting. During the study, participants will be monitored for response to treatment and side effects over a period of up to 26 months from the start of the study. Evaluations by an Independent Review Committee will include measuring the rate of total physiological complete response. Additional assessments will track other clinical outcomes and adverse events. Participants must comply with study requirements, including surgery after neoadjuvant therapy if appropriate, and safety will be closely observed throughout the trial.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating the safety and effectiveness of TQB2102 for injection, a HER2 dual-antibody-drug conjugate, in treating patients with HER2-positive biliary tract cancer. This study focuses on patients aged 18 to 75 years who have advanced or metastatic biliary tract cancer confirmed by specific tests and who have failed 1-2 prior systemic therapies. The trial is conducted in Phase 1 and Phase 2 stages to determine the recommended dose and assess adverse events. Participants receive TQB2102 injections as part of the treatment. This study includes a screening period to confirm eligibility, followed by treatment cycles where participants are monitored closely. Women of reproductive age and men must agree to use effective contraception during and for six months after the study. The study also excludes patients with certain medical conditions, recent treatments, or prior anti-HER2 therapies depending on the stage. During the study, participants undergo tumor evaluations, safety assessments, and laboratory tests to monitor the drug's effects and side effects. Researchers collect data on adverse events from the time participants consent until 28 days after the last dose or start of new antitumor therapy. The study period includes up to 24 weeks to establish the recommended dose and long-term monitoring to ensure participant safety and treatment adherence.

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 the efficacy of claseprubart (DNTH103) compared to placebo in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) in this Phase 3 study. The goal is to assess how well claseprubart works in treating this condition, which involves nerve inflammation leading to muscle weakness and sensory problems. The study consists of multiple periods: Part A is an open-label phase lasting up to 13 weeks where all participants receive claseprubart. Those who respond move to Part B, a randomized, double-blind, placebo-controlled phase lasting up to 52 weeks, where participants receive either claseprubart or placebo by infusion or injection. After Part B, eligible participants may join an optional open-label extension for up to 104 weeks. A safety follow-up period of 40 weeks follows the treatment phases. Participants will undergo various assessments including neurological evaluations and disease activity scoring. Researchers will monitor the time from the first dose to disease relapse as the main outcome. Additional safety and efficacy measures will be tracked throughout all study periods. Total participation may last over two years including extension and follow-up phases.

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.

Researchers are conducting a Phase 3 clinical trial to evaluate the safety and effectiveness of WS016 for treating hyperkalemia, a condition characterized by high potassium levels in the blood. The trial includes adults aged 18 years and older with serum potassium levels between 5.0 and 6.5 mmol/L. The study consists of two parts: Part A is a randomized, double-blind, placebo-controlled trial, and Part B is an open-label extension for eligible participants from Part A. In Part A, participants are first randomly assigned in a 5:1 ratio to receive either oral WS016 at a 12g dose or a placebo three times a day for 48 hours, totaling six doses. Following this corrective phase, those with normal potassium levels are re-randomized into one of four groups to receive WS016 at 6g, 12g, or 18g, or placebo once daily for 28 days. Participants who finish or discontinue Part A due to potassium level changes and meet eligibility criteria can join Part B, receiving WS016 once daily for 11 months. The dose in Part B starts at 12g and may be adjusted based on ongoing potassium monitoring. Throughout the study, researchers measure serum potassium levels, focusing on average levels during the 28-day maintenance phase. Participants will undergo regular blood tests and health assessments to monitor potassium and overall safety. The study also includes tracking any side effects and adjusting treatment as needed. The total duration for participants entering Part B may extend up to nearly a year, including the initial phases and the long-term extension.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.