Jin Cheng Shi

Researchers are evaluating the safety and effectiveness of 9MW1911 in people with Chronic Obstructive Pulmonary Disease (COPD) through a Phase II, multicenter, double-blind, randomized, placebo-controlled clinical trial. The study focuses on patients aged 40 to 75 years who have a history of moderate to severe COPD exacerbations and moderate-to-severe COPD lung function impairment. This trial aims to compare 9MW1911 to a placebo to better understand its impact on COPD symptoms and exacerbations. Participants will be assigned to receive either intravenous 9MW1911 or a placebo every 28 days. The treatment period lasts 52 weeks, during which the study drug is administered monthly. The trial includes careful monitoring and evaluation of the participants' lung function and health status throughout this time to assess the effects of the treatment. During the study, participants will undergo various assessments including lung function tests and monitoring for COPD flare-ups or exacerbations. The primary outcome measured is the annual rate of moderate to severe acute COPD exacerbations over 52 weeks. Safety evaluations and regular health checks will also be conducted to ensure participant well-being. The total duration of participation in the trial is one year, providing comprehensive data on treatment effects and safety.

Researchers are evaluating the long-term safety and effectiveness of drug-coated balloon (DCB) strategies compared to drug-eluting stent (DES) only treatment in patients with chronic total occlusion (CTO) of the coronary arteries after successful reopening of the artery. This study aims to provide high-quality evidence by directly comparing DCB alone or combined with DES (hybrid strategy) against DES-only treatment. The goal is to improve treatment strategies, reduce the use of stents, lower complication risks, and enhance patient outcomes for these complex heart artery blockages. The trial involves two groups: one receiving DCB angioplasty with possible provisional DES implantation if necessary, and the other receiving standard DES implantation. Both treatments use devices sized to the vessel diameter and cover the blocked segment plus surrounding healthy areas. DCB balloons are inflated to deliver medication, while stents are deployed with appropriate pressure to ensure vessel support. All patients receive standard medical therapy including at least 12 months of dual antiplatelet therapy and are followed for 36 months after the procedure. Participants will undergo assessments including angiographic imaging to measure late lumen loss at 9 months by a blinded core lab, as well as monitoring for clinical outcomes such as cardiac events, repeat procedures, and quality of life. An independent committee adjudicates clinical events. The study uses intention-to-treat analysis to compare safety and efficacy between groups. This comprehensive follow-up and evaluation plan aims to provide valuable insights into optimizing CTO treatment.

The study population are patients with acute anterior circulation large vessel occlusion stroke and planned to undergo endovascular treatment. All participants are randomly assigned in a 1:1 ratio to the tocilizumab group or the placebo group. In tocilizumab group, participants will receive tocilizumab combined endovascular treatment. And in placebo group, participants will receive placebo combined endovascular treatment. All participants will be visited immediately postoperatively, at 24 hours, 7 days, and 90 days after randomization.

Researchers are studying patients with unresectable non-small cell lung cancer (NSCLC) to evaluate the safety and effects of nintedanib combined with sequential radiotherapy. The study focuses on the incidence of radiation pneumonitis above grade 2 and also aims to explore progression-free survival (PFS) and overall survival (OS) in patients receiving this treatment alongside immunotherapy. This is a prospective, multicenter phase II clinical study. Patients first receive induction therapy, including chemotherapy and/or immunotherapy for at least one cycle. Following this, participants undergo sequential radiotherapy while taking nintedanib for six months. Afterward, they receive immunotherapy maintenance therapy for 16 cycles. Nintedanib is administered during the sequential radiotherapy period to observe its effects on radiation pneumonitis and safety. Throughout the study, patients will be closely monitored for safety and lung function changes. Researchers will assess the incidence rate of radiation pneumonia over up to two years and track progression-free and overall survival. The study requires patient cooperation for follow-up and compliance to assess the long-term outcomes and safety of combining nintedanib with radiotherapy and immunotherapy for unresectable NSCLC.

Researchers are evaluating the efficacy and safety of Shuxuening injection as an additional treatment to intravenous thrombolysis in patients with acute ischemic stroke. This multicenter, randomized, double-blind, placebo-controlled phase 3 trial involves patients aged 18 to 100 years who have experienced an ischemic stroke and can be treated within 6 hours of symptom onset. The study aims to improve functional outcomes by reducing brain cell death after stroke using this multi-target neuroprotective agent alongside the standard clot-busting therapy. Participants are randomly assigned in a 1:1 ratio to receive either Shuxuening injection or a placebo. Both groups receive a daily intravenous drip of 20 ml of the study drug or placebo combined with 250 ml of 0.9% sodium chloride injection for 10 to 14 days. The treatment starts as soon as possible after intravenous thrombolysis therapy, and the study compares these two groups to assess differences in recovery and safety. During the trial, researchers will monitor participants for 90 days after randomization. They will assess the primary outcome by measuring the proportion of patients achieving a modified Rankin Scale (mRS) score of 0 to 1, indicating good functional recovery. Safety will be evaluated by tracking adverse events over the same 90-day period. Participants will be closely followed with clinical evaluations to understand the effects and tolerability of Shuxuening injection in stroke recovery.

Researchers are evaluating the preliminary effectiveness and safety of Tislelizumab combined with thoracic radiotherapy as a first-line treatment for patients with extensive-stage small cell lung cancer. This is a single-arm, open-label, multicenter phase II study focused on this specific lung cancer type. The study aims to measure progression-free survival over a period of up to two years. Participants receive Tislelizumab infusions at a dose of 200 mg every three weeks for up to two years. Additionally, chemotherapy with Etoposide is given intravenously at 100 mg/m2 on days 1 to 3 every three weeks for four cycles. Patients also receive either Carboplatin or Cisplatin chemotherapy intravenously every three weeks for four cycles, with dosages adjusted accordingly. Concurrently, thoracic radiotherapy is administered using intensity-modulated radiation therapy (IMRT) at doses ranging from 30 to 45 Gy delivered in 10 to 15 fractions. Throughout the study, patients undergo regular imaging to evaluate measurable lesions and assessments to monitor vital organ function and overall health. The main outcome measured is progression-free survival for up to two years. Researchers also monitor safety and treatment compliance, and participants are followed closely to observe treatment effects and any side effects during and after the therapy period.