Jin Cheng Shi

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 9MW1911 in adults aged 40 to 75 who have been diagnosed with Chronic Obstructive Pulmonary Disease COPD for at least one year. This Phase II clinical trial is designed to assess how well 9MW1911 works and how safe it is for treating COPD. The study compares two different doses of 9MW1911 given intravenously with a placebo, and aims to better understand treatment effects on COPD flare-ups and lung function. Participants receive intravenous infusions of either 9MW1911 in one of two dose levels or a placebo every 28 days. Each treatment group includes 120 patients, all receiving stable standard care for COPD. The study lasts for 52 weeks of treatment, followed by safety and immune response monitoring up to 60 weeks. Researchers measure lung function, COPD exacerbations, quality of life, and other health markers during this period. During the study, participants will have regular visits for lung function tests, questionnaires about COPD symptoms and quality of life, blood tests, and safety assessments. These assessments occur at multiple time points, such as weeks 0, 4, 8, 12, 24, 36, and 52. The main outcome is the rate of moderate to severe COPD exacerbations over one year. Additional measures include lung function changes, time to first exacerbation, and biological markers. Safety and tolerability are followed for up to 60 weeks to ensure participant well-being throughout the trial.

Researchers are evaluating the long-term effectiveness and safety of drug-coated balloon DCB strategies, including DCB alone or combined with drug-eluting stents DES, compared to DES-only treatment in patients with chronic total occlusion CTO of coronary arteries after successful reopening. This multicenter randomized controlled trial aims to fill the gap in direct comparative data between DCB and DES treatments for CTO, with the goal of optimizing treatment strategies, reducing stent use, lowering complication risks, and improving patient outcomes. Participants will be randomly assigned to either the DCB group, which involves balloon angioplasty with drug coating and possible provisional DES implantation if needed hybrid strategy, or the DES-only group receiving standard drug-eluting stent placement. Both groups receive standard medical therapy including at least 12 months of dual antiplatelet therapy DAPT. The study includes a 9-month primary endpoint assessment and a 36-month follow-up period to monitor long-term outcomes. During the study, patients will undergo angiographic evaluation for late lumen loss at 9 months, assessed by an independent laboratory using quantitative coronary angiography. Clinical events such as target lesion failure, cardiac death, myocardial infarction, and repeat revascularization will be monitored up to 36 months. Patient-reported outcomes like angina status and quality of life, as well as intravascular imaging and safety parameters, will also be collected. Overall participation spans over three years with regular follow-up visits to assess treatment effects and safety.

This research aims to study patients with unresectable non-small cell lung cancer NSCLC who receive nintedanib alongside sequential radiotherapy. The study evaluates the occurrence of significant radiation pneumonitis above grade 2 and monitors the safety of combining nintedanib with radiotherapy. Additionally, the study will observe progression-free survival PFS and overall survival OS in patients treated with nintedanib plus radiotherapy and immunotherapy. Participants will first undergo induction therapy, including chemotherapy andor immunotherapy for at least one cycle. Following this, they will receive sequential radiotherapy combined with nintedanib treatment for six months. After completing this phase, patients will continue with maintenance immunotherapy for 16 cycles as part of their treatment plan. Throughout the study, participants will be monitored for safety and the incidence of radiation pneumonia for up to two years. Lung function, PFS, and OS will also be assessed during this period. The total follow-up and observation will last up to two years to evaluate these outcomes and monitor patient health comprehensively.

Researchers are evaluating Shuxuening injection, a multi-target neuroprotective agent, to see its effects when added to intravenous thrombolysis therapy in patients with acute ischemic stroke. This large, multicenter, randomized, double-blind, placebo-controlled trial aims to assess the effectiveness and safety of Shuxuening injection in improving outcomes after stroke. Intravenous thrombolysis with rt-PA is the current standard treatment, but many patients still experience significant disability, so neuroprotective agents like Shuxuening may help reduce brain cell death. Participants will be randomly assigned to one of two groups one group will receive Shuxuening injection combined with intravenous thrombolysis, and the other will receive a placebo combined with intravenous thrombolysis. Both treatments involve a daily intravenous drip of 20 ml Shuxuening or placebo plus 250 ml of 0.9% sodium chloride for 10 to 14 days. The study plans to enroll 1380 patients within 6 hours of stroke onset from 50 centers across China. During the study, participants will be monitored closely with assessments including the modified Rankin Scale mRS score at 90 days to measure functional recovery, along with safety monitoring for adverse events over 90 days. Other evaluations include neurological function scores, quality of life surveys, and various safety outcomes. The trial will last for at least 90 days after treatment, with data collected on disability, recovery, and any side effects experienced.

Researchers are evaluating the preliminary effectiveness and safety of Tislelizumab combined with thoracic radiotherapy and chemotherapy as a first-line treatment for patients with extensive-stage small cell lung cancer. This is a phase II, single-arm, open, multicenter study aiming to explore this combination therapy in people newly diagnosed with this condition. Participants will receive Tislelizumab infusions 200 mg every 3 weeks for up to 2 years. They will also receive chemotherapy with Etoposide plus either Carboplatin or Cisplatin for 4 cycles every 3 weeks. Concurrent thoracic radiotherapy will be given using intensity-modulated radiation therapy IMRT with doses between 30 to 45 Gy over 10 to 15 fractions. Throughout the study, participants will be closely monitored with imaging to assess tumor response and disease progression for up to 2 years. Researchers will track progression-free survival as the main outcome, along with response rates, overall survival, and any side effects. Participants will have regular visits for assessments and follow-ups to monitor treatment effects and safety during and after therapy.

Researchers are evaluating the safety and effectiveness of TQC2731 injection in adults with severe asthma that is not well controlled. This is a Phase III clinical trial where 660 participants with asthma are randomly assigned to receive either TQC2731 or a placebo. The study aims to see if TQC2731 can reduce asthma worsening episodes over one year compared to placebo. Participants receive either the TQC2731 injection or placebo every four weeks for up to 48 weeks through subcutaneous injection. The treatment cycles repeat monthly from the start until Week 48. The study compares these two groups to assess the impact on asthma symptoms and lung function. Throughout the trial, participants will have regular assessments including lung function tests, asthma symptom diaries, quality of life questionnaires, and blood tests for inflammation markers and immune response. Researchers track the number of asthma exacerbations during the 52 weeks of treatment and up to 64 weeks for some outcomes. Safety and immune reactions are monitored carefully. The total study duration for each participant is about one year of treatment plus follow-up.