Chi Feng Shi

Researchers are evaluating the effectiveness and safety of TQB2102 for injection compared to a standard chemotherapy regimen called TCbHP in patients with HER2-positive breast cancer. This phase III, randomized, open-label, multi-center study focuses on neoadjuvant treatment, which is therapy given before surgery. The study aims to measure the total pathological complete response and other outcomes such as event-free survival and overall survival. Participants receive either TQB2102 for injection at 6 mgkg by intravenous infusion every 3 weeks for 8 cycles or a combination of Trastuzumab, Pertuzumab, Docetaxel, and Carboplatin given intravenously every 3 weeks for 6 cycles. The study monitors participants throughout the treatment period and collects data on tumor response and side effects. During the study, participants will undergo assessments including tumor response evaluations by independent review and investigators, safety monitoring for adverse events, and laboratory tests. Follow-up will continue for up to 50 months after the start of the study to observe long-term outcomes. Participants are expected to comply with contraceptive use requirements and attend all scheduled visits for treatment and evaluations.

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, safety, and tolerability of combining elecoglipron and dapagliflozin compared to each drug alone in adults with type 2 diabetes mellitus T2DM who have not achieved adequate control through lifestyle changes or other glucose-lowering medications. This Phase III study aims to better understand how these treatments work together in managing blood sugar levels in this population. Participants are randomly assigned to one of five groups two groups receive elecoglipron at different dose levels combined with dapagliflozin two groups receive elecoglipron at different dose levels combined with a placebo matching dapagliflozin and one group receives dapagliflozin alone with a placebo matching elecoglipron. All medications are taken orally once daily. The treatment period lasts 40 weeks, during which the effects of the drugs on blood sugar and other health measures will be monitored. Throughout the study, participants will have regular assessments of their blood sugar control, body weight, and blood pressure. Researchers will measure changes in Hemoglobin A1c HbA1c, fasting plasma glucose, and self-monitored blood glucose levels. Other outcomes include weight loss and the need for rescue medication. Safety and tolerability will be closely monitored. Participation in the trial lasts for 40 weeks, during which participants will attend scheduled visits for evaluation and medication monitoring.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are studying the safety and effectiveness of TQB2102 for injection in patients with HER2-positive biliary tract cancer. This includes patients with locally advanced or metastatic forms of the disease who have experienced failure of 1-2 prior systemic therapies. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. and spans phases 1 and 2 to evaluate dosing, safety, and immune response. Participants receive TQB2102, a HER2 dual-antibody-drug conjugate, by intravenous infusion every three weeks in cycles of 21 days. Treatment involves 6 to 8 cycles, with ongoing monitoring for adverse events and response to therapy. The study does not use masking or placebo controls. During the trial, participants undergo assessments for tumor response, disease control, survival, and side effects from the time of consent until 28 days after the last dose or the start of a new antitumor therapy. Follow-up includes evaluations up to 36 weeks for outcomes like progression-free and overall survival. Participants also provide tumor tissue samples for HER2 testing and are monitored for immune reactions and safety throughout the study.

Researchers are evaluating whether Extract of Ginkgo Biloba Leaves Tablets can improve memory and thinking skills in people aged 55 and older who have had an ischemic stroke caused by a blocked blood vessel in the brain. This study also looks at the safety of taking these tablets alongside usual post-stroke treatments. Participants must have had a stroke confirmed by MRI within 7 to 14 days before joining the study and have mild cognitive impairment after their stroke. Participants will be randomly assigned to one of two groups one group will take 240 mg of Extract of Ginkgo Biloba Leaves Tablets daily for 12 months in addition to their usual stroke care, while the other group will receive only their usual care without the tablets. The study will take place at hospitals across China and will last for 52 weeks for each participant. Throughout the study, participants will visit the clinic at 4, 26, and 52 weeks after starting treatment for checkups and tests, including brain scans, cognitive assessments such as the Montreal Cognitive Assessment and other neuropsychological tests, and evaluations of neurological function. Follow-up phone calls will occur at 12 and 38 weeks to monitor health and any new stroke events. Researchers will measure changes in thinking, memory, cognitive speed, verbal skills, and neurological status to understand the tablets effects and safety over time.

Researchers are evaluating the effectiveness of claseprubart DNTH103 compared to a placebo in adults with chronic inflammatory demyelinating polyneuropathy CIDP. This Phase 3 study aims to assess treatment outcomes in participants with typical CIDP or certain CIDP variants, focusing on improving disease activity and disability measures. The study consists of several periods Part A includes an open-label phase lasting up to 13 weeks where participants receive an intravenous loading dose of claseprubart followed by subcutaneous injections every two weeks. Part B is a randomized, placebo-controlled, double-blind treatment phase lasting up to 52 weeks for those who respond to treatment in Part A, with participants receiving either claseprubart or placebo subcutaneously every two weeks. Eligible participants may then join an optional open-label extension lasting up to 104 weeks, continuing claseprubart treatment subcutaneously every two weeks, followed by a safety follow-up period of 40 weeks. Participants will undergo regular assessments throughout the study, including evaluations of disease relapse using the Adjusted Inflammatory Neuropathy Cause and Treatment INCAT score, disability scales, grip strength measurements, quality of life, fatigue severity, and antibody levels. Safety monitoring involves tracking adverse events and drug serum concentrations. The total study duration can extend up to approximately 209 weeks, including all treatment and follow-up phases, with careful monitoring of participants neurological stability and treatment responses.

This trial is for adults who have had an acute ischemic stroke caused by a blood clot blocking a brain vessel. It focuses on people whose stroke occurred or was discovered more than 4.5 hours ago, including those who woke up with stroke symptoms. The study aims to find out if the medicine tenecteplase helps recovery when given after this 4.5-hour window, compared to standard medical care. Tenecteplase is already used within 4.5 hours after stroke onset, but this study tests its effect when given later. Participants are randomly assigned to one of two groups one receives a single injection of tenecteplase into a vein, and the other receives the usual standard treatment. Both groups have an equal chance of receiving either treatment. The study lasts about three months, starting with approximately one week of hospital stay. During the study, participants have seven clinical examinations or visits, with the final two visits conducted remotely from home to allow for easier participation. Throughout the study, doctors regularly assess participants recovery using a scale that measures disability and dependence in daily activities. They also monitor overall health and record any side effects. The main outcome measured is the level of recovery 90 days after treatment, comparing the two groups. This includes neurological improvement, bleeding events, and survival over the study period.

Researchers are evaluating the drug WS016 in adults with hyperkalemia, a condition characterized by elevated potassium levels in the blood. This Phase 3 clinical trial aims to study the effectiveness and safety of WS016 through a two-part design including a corrective phase to quickly reduce potassium levels and a maintenance phase to keep potassium normal. An open-label extension phase is also included to assess longer-term treatment effects. In Part A, participants are first randomized to receive either oral WS016 12g or placebo three times daily for 48 hours during the corrective phase. Those who achieve normal potassium levels are then re-randomized to receive WS016 at doses of 6g, 12g, or 18g, or placebo once daily for 28 days in the maintenance phase. Part B is an open-label extension lasting 11 months, where participants receive WS016 starting at 12g daily, with dose adjustments based on potassium levels. Participants will have regular blood tests to monitor serum potassium and other health measures throughout the study. Researchers will track potassium levels during the maintenance phase and corrective phase to assess drug effects. Safety and tolerability will be monitored, and participants completing or discontinuing the maintenance phase may continue treatment in the extension phase. Overall participation can last up to nearly a year depending on enrollment in Part B.