Tai Zhou Shi

This research focuses on lung cancer patients receiving thoracic radiotherapy, aiming to study radiation pneumonitis, a common side effect that can limit treatment dose and affect quality of life, survival, and therapy outcomes. The study seeks to identify biomarkers such as serum proteins, gene expression, genetic and epigenetic changes that influence radiation pneumonitis. It also examines the connection between radiation pneumonitis and other radiotherapy-related toxicities, and evaluates survival and treatment effectiveness in affected patients. Participants are observed in a multicenter prospective design where clinical information, CT images, and blood samples are collected before, during, and after radiotherapy. Follow-up visits occur during and one month after treatment, then every three months for the first year, and every six months afterward. Biomarker detection includes serum proteins, gene profiles, genetic variants, and epigenetic markers. Statistical models and machine learning techniques are used to build predictive models of radiation pneumonitis and to analyze its relationship with survival and treatment outcomes. During the study, patients undergo chest CT scans and clinical assessments at scheduled follow-ups to monitor radiation pneumonitis and other toxicities graded by oncologists. Researchers collect data on survival status, symptoms, and treatment throughout up to five years. The main outcomes measured are radiation pneumonitis incidence 12 months post-radiotherapy and overall survival at five years. Secondary outcomes include other radiotherapy-induced injuries. This long-term monitoring helps understand and predict adverse effects of thoracic radiotherapy in lung cancer patients.

Researchers are evaluating the efficacy and safety of two inhalers, BDA MDI budesonide and albuterol and AS MDI albuterol sulfate, in reducing severe asthma attacks among symptomatic Chinese adults with asthma. This Phase III, randomized, double-blind, multicenter study involves about 1000 participants who have been diagnosed with asthma and continue to experience symptoms despite maintenance therapy. Participants will be randomly assigned to receive either BDA MDI 160180 mcg two puffs of 8090 mcg or AS MDI 180 mcg two puffs of 90 mcg as needed to relieve asthma symptoms or before exercise. The study includes a screening period lasting 14 to 28 days, followed by a treatment period of at least 24 weeks and up to 52 weeks, and concludes with a safety follow-up about two weeks after the last treatment visit. During the trial, participants will attend regular visits to monitor their asthma control and lung function. Researchers will assess the time to the first severe asthma exacerbation, the rate of exacerbations, steroid use, and responses to asthma control questionnaires. Safety will be carefully followed during and after treatment, with the total participation lasting up to approximately one year.

Researchers are evaluating the efficacy and safety of orelabrutinib in adults with systemic lupus erythematosus SLE who are already receiving standard care treatments. This phase IIb study is randomized, double-blind, placebo-controlled, and conducted at multiple centers to better understand how well orelabrutinib works and how safe it is for this population. Participants are assigned to one of three groups receiving either a low dose of orelabrutinib, a high dose of orelabrutinib, or a placebo. All treatments are taken orally once daily alongside standard of care therapy. The study lasts 48 weeks, with assessments continuing up to 52 weeks to monitor safety and treatment responses. During the trial, participants will have regular evaluations measuring their response to treatment using tools like the SLE Responder Index and assessments of lupus flare timing. Researchers will also track changes in health surveys, antibody levels, and medication use. Safety is closely monitored through reports of adverse events, with the full study duration extending slightly beyond the treatment period for follow-up.

Researchers are evaluating the long-term safety, effectiveness, and immune response of two doses of TQH2722 injection in adults with severe chronic sinusitis, with or without nasal polyps. This Phase II, multicenter, randomized trial aims to expand understanding of TQH2722s role in managing this condition over an extended period. Participants receive either 300mg or 600mg of TQH2722 injection every two weeks until week 22, combined with daily use of Mometasone furoate nasal spray at doses of 100-200 mcg until week 32. The study includes two parts A and B, with similar treatment schedules and follow-up visits to monitor the treatment effects. During the study, participants undergo regular assessments including monitoring for treatment-emergent adverse events up to 32 weeks. Researchers measure changes in sinus imaging scores, smell identification tests, symptom scores, nasal polyp sizes, and immune responses. Safety evaluations include laboratory tests and monitoring for serious adverse events. The total study duration includes treatment and follow-up visits over approximately 32 weeks.

Radiation-induced lung injury RILI is a common complication after thoracic radiotherapy, occurring in about 31.4% of patients. This condition, sometimes combined with immune-checkpoint inhibitor-related pneumonitis CIP, can disrupt cancer treatment and negatively affect patient outcomes. Both RILI and CIP share similar symptoms like fever, dry cough, and chest pain, and diagnosis involves symptom assessment and imaging such as computed tomography CT. This trial aims to find the best dose and evaluate the safety and effectiveness of pirfenidone capsules for treating RILI with or without CIP, addressing a critical need for better therapies. The study has two phases Phase II focuses on finding the optimal dose of pirfenidone, testing low-dose 400 mg three times daily, high-dose 600 mg three times daily, and placebo groups over 168 days of treatment and observation, followed by safety and survival follow-up. Phase III will confirm the chosen doses effects compared to placebo with a similar schedule and includes a long-term extension phase with survival assessments every three months. Participants will receive oral pirfenidone capsules or placebo with meals during the treatment period. Participants will undergo regular assessments including lung function tests like diffusing capacity of the lung for carbon monoxide DLCO, forced vital capacity FVC, and forced expiratory volume in one second FEV1. Other evaluations include symptom scores, CT imaging, blood tests, and monitoring for adverse events. The primary outcome is the change in lung diffusion capacity at 24 weeks. Safety follow-up occurs for about a month after treatment, and long-term monitoring continues in the extension phase. The total study participation spans from screening through treatment, safety follow-up, and extended survival tracking.

Researchers are evaluating a smartwatch-based multi-faceted cardiovascular health intervention among overweight or obese adults with cardiometabolic preconditions such as prehypertension, prediabetes, or borderline dyslipidemia. This prospective, multicenter, parallel-group, open-label cluster randomized controlled trial aims to provide evidence and guidance for preventing and managing cardiovascular risks in this population. The study plans to enroll about 1,400 participants from approximately 40 community clusters in urban and rural regions. Participants will be assigned to either the intervention group or the control group. The intervention group receives a comprehensive behavioral program delivered through smartwatches and a WeChat mini-program, supported by primary healthcare providers and an integrated platform. This includes monitoring, goal setting, community interaction, and face-to-face health education during the first 6 months, followed by 6 months of self-management support. The control group receives only face-to-face health education throughout the 12-month study period. During the study, participants will attend follow-up assessments at 3, 6, and 12 months. Researchers will evaluate changes in Lifes Essential 8 components, which include diet, physical activity, smoking, sleep, BMI, blood lipids, blood glucose, and blood pressure. The main outcome is the change in the Lifes Essential 8 risk score at 6 months, with secondary measurements taken at 3 and 12 months. The study also tracks individual health factors and provides ongoing monitoring and support to participants throughout the year-long trial.

Researchers are studying the value of pleural lavage cytology PLC in patients with esophageal cancer who are undergoing surgery to remove their tumors. The study aims to find out how often positive PLC results occur, how PLC results relate to patient survival, and how effective postoperative treatments are in these patients. PLC has been linked to disease recurrence and survival in lung cancer, but its role in esophageal cancer is not yet clear. During the study, pleural lavage samples will be collected both before and after esophageal tumor removal surgery. The frequency of positive PLC results will be recorded to evaluate its significance for patients with resectable esophageal cancer. This observational study involves no drug treatments but focuses on monitoring and assessing PLC findings around the surgical procedure. Participants will undergo pleural lavage before and after surgery, and researchers will follow their outcomes over time. The main measure is the number of patients with positive pleural lavage cytology within one year after starting the study. Secondary measures include the time from surgery to death, tracked up to four years. This long-term follow-up helps assess the relationship between PLC results and patient survival, with data collected from July 2022 through July 2027.