Huwei Township

Researchers are evaluating the safety, tolerability, and anticancer activity of CHO-H01 in adults with relapsed or refractory CD20-positive non-Hodgkins lymphoma. This study includes two parts Phase 1 focuses on finding the maximum tolerated and recommended doses of CHO-H01 alone, while Phase 2a assesses the combination of CHO-H01 with lenalidomide in patients with low-grade lymphoma types. The study aims to better understand treatment options for this condition, sponsored by Cho Pharma Inc. In Phase 1, participants receive intravenous infusions of CHO-H01 once weekly for 4 weeks during the first 28-day cycle, then once every 21-day cycle for up to 6 cycles or until disease progression. Dose levels range from 0.5 mgkg to 12 mgkg in escalating cohorts. After confirming the recommended dose, Phase 2a begins, where subjects receive the recommended dose of CHO-H01 combined with daily oral lenalidomide for 21 days in each 28-day cycle. Participants will undergo regular assessments including monitoring for adverse events, dose-limiting toxicities, and tumor response over approximately 16 months. Researchers will measure serum drug concentrations, immune responses, and clinical outcomes such as time to progression and survival. Safety and efficacy are closely followed through laboratory tests, imaging, and clinical evaluations during and after treatment to understand the benefits and risks of these therapies.

Researchers are evaluating whether adding high-dose-rate HDR brachytherapy can improve outcomes for patients with locally advanced esophageal squamous cell carcinoma ESCC who have already received external beam radiotherapy EBRT, chemotherapy, and the immune therapy drug nivolumab. This phase II trial aims to see if HDR brachytherapy reduces the chance of cancer returning in the esophagus or nearby areas within 12 months and to assess safety and side effects when given after the other treatments. The study is sponsored by National Taiwan University Hospital and focuses on patients with stage III-IVB ESCC. Participants receive 1-2 sessions of HDR brachytherapy, delivered through a thin tube inside the esophagus, starting within three weeks after the first cycle of nivolumab. The brachytherapy dose ranges from 5 to 12 Gy, given in 1-2 fractions, targeting the tumor precisely while avoiding damage to normal tissues. Nivolumab is given intravenously every two weeks for several cycles alongside brachytherapy, but chemotherapy is not given on brachytherapy days. Imaging and CT scans are used for treatment planning and applicator adjustment. During the study, participants will have regular follow-up visits with imaging tests and blood samples to monitor treatment response, safety, and tumor markers. Researchers will measure the 12-month locoregional failure rate as the primary outcome and also monitor overall survival, progression-free survival, response rates, disease control, side effects, tube dependence, tumor immune activity, and circulating tumor DNA over up to 24 months. The total participation time may last up to two years with close monitoring for side effects and disease progression.

Researchers are evaluating the safety and effectiveness of a new therapy using a patients own dendritic cells DCs and natural killer NK cells cultured in the lab to treat advanced non-small cell lung cancer NSCLC. This Phase 2 study focuses on patients with stage IIIB or IV NSCLC, including those with recurrence or progression after other treatments. The goal is to understand how these immune cells behave when given via lymph node injection and intravenous infusion and to explore their ability to fight cancer cells. Participants receive autologous dendritic cells injected into the axillary lymph nodes and natural killer cells through intravenous infusion. These cell formulations are cultured in vitro to boost their anti-cancer properties. The study assesses the safety of these treatments by monitoring reactions after administration. The trial also measures the success of cell preparation, including cell viability and tumor-killing capacity, and evaluates tumor responses using standard criteria during the 12-week treatment period. During the study, participants undergo regular monitoring including blood tests to check blood counts and liver and kidney function before cell collection. Researchers track adverse events and measure tumor response to the therapy with specified timelines up to 12 weeks. Participants must meet specific health criteria and agree to follow-up visits. The primary focus is on safety, while secondary outcomes include the effectiveness of the cultured cells against the cancer. The entire participation timeline includes screening, treatment, and evaluation phases.

Researchers are evaluating how mindfulness-based programs and brain stimulation affect cognitive abilities and emotional well-being in older adults. This study focuses on understanding how these non-drug treatments might improve mental health or reduce signs of depression in late-life adults. It uses a variety of psychological, behavioral, and brain imaging tests to measure these effects. Participants will be assigned to one of four groups Mindfulness-Based Stress Reduction, Mindfulness-Based Well-Being Curriculum, Mindfulness-Based Curriculum for Insomnia, or Brain Stimulation Intervention. The study includes a baseline assessment before the treatments start and follow-up assessments to track changes after completing the interventions. Those joining the study will undergo multiple evaluations including brain scans to observe changes in brain activity and structure, psychological tests like the Wechsler Adult Intelligence Scale, and self-reported measures of mood, sleep, stress, and well-being. Continuous monitoring with smart watches will collect data on sleep and heart function over a 16-week period. The study lasts from before the intervention through one month after finishing the treatments, with detailed tracking of mental and physical health changes.

Researchers are evaluating treatments for men with high-risk locally advanced prostate cancer, focusing on the effectiveness and safety of neoadjuvant hormone and radiation therapy followed by radical prostatectomy. This two-stage randomized trial compares neoadjuvant hormone therapy combined with radiation therapy against hormone therapy alone before surgery. The study aims to understand if adding radiation therapy before surgery improves outcomes for this condition. Participants are randomly assigned to one of two groups. The first group receives intensity modulated radiation therapy IMRT delivering 50 Gy over 25 daily fractions for 5 weeks, along with hormone therapy using Goserelin 3.6 mg injections at weeks 1, 5, and 9, followed by robotic-assisted radical prostatectomy and pelvic lymph node dissection. The second group receives only the hormone therapy injections at the same schedule before undergoing the prostatectomy. After these interventions, participants are monitored for up to 20 years. During the study, participants will be assessed for the success of salvage radiation therapy by measuring pathologic complete or near-complete response at surgery, PSA decline rates, surgical margin status, and disease staging. Researchers will also track biochemical recurrence-free survival, metastasis-free survival, prostate cancer-specific death, and overall survival over a period of up to 10 years. Follow-up visits will include regular evaluations to monitor these outcomes and ensure safety throughout the long-term study.

Chronic Obstructive Pulmonary Disease COPD is a major global health issue, leading to high morbidity and mortality, especially in low- and middle-income countries. Frequent exacerbations worsen the disease and increase death risk. Current guidelines recommend triple inhaled therapy combining an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta2-agonist for patients with persistent symptoms. BreztriTrixeo BGF is one such therapy approved based on controlled clinical trials, but real-world data on its effectiveness and patient experience is needed. This observational study, called iCHOROS, will follow adults with moderate to severe COPD treated with BGF in routine clinical settings across Latin America, Asia, and the Middle East & Africa. Participants will be observed for 12 months after starting BGF, with assessments at baseline, 12, 26, and 52 weeks. The study collects clinical data and patient-reported outcomes without altering the standard care or providing study medication, focusing on real-life use and effects of BGF. Participants will have their COPD status, symptom scores, lung function, exacerbation history, and treatment satisfaction recorded during scheduled visits. The main measure is the change in COPD Assessment Test CAT score after 12 weeks. Additional measures include exacerbation rates, dyspnea severity, spirometry, and patient satisfaction with inhalers. The study aims to provide insights into BGFs impact in diverse populations over one year of follow-up.

Researchers are studying bronchiectasis in adults and adolescents aged 12 to under 18 who produce sputum and have experienced flare-ups. The trial aims to evaluate whether the medicine BI 1291583 can help reduce these flare-ups compared to a placebo. Participants are randomly assigned to receive either BI 1291583 or a placebo in a phase III, double-blind study. Participants take one tablet of either BI 1291583 or placebo once daily for up to 1 year and 6 months. The study includes two groups one receiving the active medication and the other receiving placebo tablets that look identical but contain no medicine. The study period lasts up to 1 year and 8 months, during which participants attend up to 10 site visits and receive about 13 phone calls. During the study, participants regularly record their bronchiectasis symptoms in a smartphone diary. Study doctors monitor participants health, note any flare-ups, and check for unwanted effects. Researchers compare the number of flare-ups between the two groups as the primary measure. Secondary measures include time to first flare-up, quality of life changes, lung function changes, and rates of severe flare-ups.