Binh Luc

Researchers are evaluating the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma LA-HNSCC who have not progressed after receiving definitive concurrent chemoradiotherapy cCRT. This phase III, randomized, open-label global study aims to assess whether volrustomig can improve outcomes in this patient population. Participants are randomly assigned to one of two groups those who receive volrustomig as sequential therapy, and those who undergo observation without additional treatment. The study compares these two approaches following prior curative concurrent chemoradiotherapy. The trial includes long-term follow-up to monitor patient outcomes. During the study, participants will be regularly assessed for progression-free survival, overall survival, physical functioning, and quality of life. Researchers will also monitor for the presence of anti-drug antibodies and adverse events related to volrustomig. Follow-up evaluations may continue for up to approximately eight years to fully understand the treatment impact and safety profile.

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 elecoglipron compared with placebo in adults who have type 2 diabetes mellitus T2DM with impaired kidney function. Participants are also on dapagliflozin 10 mg as part of their guideline-directed medical therapy for chronic kidney disease CKD, along with other glucose-lowering medications. This Phase III study aims to understand how elecoglipron performs in this specific group of patients. Participants will be randomly assigned to one of three groups elecoglipron at dose level 1, elecoglipron at dose level 2, or placebo. All treatments are given orally once daily alongside background dapagliflozin 10 mg. The study uses a parallel design and includes a 40-week treatment period during which participants take their assigned medication. During the study, participants will have their blood sugar control measured through Hemoglobin A1c HbA1c levels from baseline to Week 40, which is the primary outcome. Additional assessments include body weight changes, blood pressure, fasting plasma glucose, and time to needing additional diabetes medication. Safety and tolerability will be monitored throughout the study, which lasts up to 40 weeks for each participant.

Researchers are evaluating AZD0292, a bispecific IgG1k monoclonal antibody, for preventing exacerbations in bronchiectasis patients who are chronically colonized with Pseudomonas aeruginosa PsA. This Phase IIb study compares two dosage regimens of AZD0292 administered intravenously with placebo in participants aged 12 years and older. The study mainly focuses on non-cystic fibrosis bronchiectasis patients with frequent pulmonary exacerbations due to chronic PsA colonization, which negatively affects lung function, quality of life, and survival. Additionally, patients with cystic fibrosis bronchiectasis colonized with PsA are included as an exploratory group. Participants will receive either high-dose or low-dose AZD0292 starting on Day 1 via IV infusion, or placebo administered similarly. Subsequent doses will follow a schedule of assessments. This randomized, double-blind, placebo-controlled, parallel study aims to assess the efficacy, safety, and pharmacokinetics of AZD0292 over a variable follow-up period ranging from a minimum of 28 weeks up to 52 weeks. The trial also includes monitoring for adverse events and immune responses to the treatment. During the study, participants will undergo evaluations including lung function tests, quality of life questionnaires, and monitoring of exacerbation rates. Blood samples will be collected to measure drug concentration and antibody development. Safety assessments will continue through the treatment period and for up to 24 weeks after the last dose. The primary outcome is the annualized rate of exacerbations over the follow-up time, and secondary measures include severe exacerbation rates, time to first exacerbation, and changes in quality of life scores. Total participation spans from screening through the treatment and follow-up phases.

Researchers are evaluating the effect of AZD6793, an oral medication, in adults with moderate to very severe chronic obstructive pulmonary disease COPD. This Phase IIb, randomized, double-blind, placebo-controlled study involves approximately 970 participants across about 350 global sites. The trial aims to compare the efficacy and safety of two different doses of AZD6793 against placebo over a 24-week period. Participants will be randomly assigned to one of three groups receiving either dose 1 of AZD6793, dose 2 of AZD6793, or a matching placebo tablet. The study medication is taken orally and the trial lasts for 24 weeks. The study is designed as a parallel-group format with a 111 allocation ratio among the three arms. During the study, participants will be monitored through various assessments including lung function tests measuring forced expiratory volume FEV1, questionnaires evaluating breathlessness, cough, sputum, and quality of life, and tracking of COPD exacerbation events. Blood samples will be collected to measure plasma concentrations of AZD6793. Safety and efficacy outcomes will be evaluated up to 24 weeks, with the main outcome being the rate of moderate or severe COPD exacerbations.

Researchers are evaluating the effectiveness and safety of subcutaneous anifrolumab compared with a placebo in adults with moderate to severe Idiopathic Inflammatory Myopathies IIM, including polymyositis PM and dermatomyositis DM. This phase III, multicenter, randomized, placebo-controlled, and double-blind study aims to assess how adding anifrolumab to standard care affects overall disease activity in these patients. Participants will receive either anifrolumab or a matching placebo as a subcutaneous injection once a week for 52 weeks, alongside their standard of care treatments. After this initial period, all participants will be offered open-label anifrolumab once weekly for an additional 52 weeks, allowing further evaluation of long-term treatment effects. During the study, participants will be monitored through various assessments including muscle strength tests, disease activity scores, corticosteroid usage, and skin severity indexes over 52 weeks. The main outcome measure is the Total Improvement Score response at 52 weeks. Safety and disease activity will be carefully tracked throughout the treatment and follow-up periods, with study participation potentially lasting up to two years.

Researchers are evaluating the combined use of vicadrostat and empagliflozin in adults with chronic heart failure who have a reduced left ventricular ejection fraction LVEF below 40%. Participants must have had chronic heart failure diagnosed at least three months before starting the study. The trial aims to find out if this combination helps people with symptomatic heart failure classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups, with an equal chance of receiving either vicadrostat plus empagliflozin tablets or placebo plus empagliflozin tablets. The study medicines are taken once daily for approximately six months up to about 3.5 years. During this time, participants may continue their usual heart failure treatments, excluding certain medications. The trial includes a double-blind design, meaning neither participants nor study staff know who receives the active drug or placebo. Throughout the study, participants visit the study site regularly, with the number of visits depending on how long they stay enrolled. Some visits may occur by phone. They answer questions about their well-being, and doctors monitor health status, record any heart failure worsening, hospitalizations, or deaths. The main outcome is the time until cardiovascular death, heart failure hospitalization, or urgent heart failure visit, which is compared between groups. Safety and side effects are also closely followed during the trial.

Researchers are evaluating an artificial intelligence AI-based multimodal model designed to predict major cardiovascular events within 30 days after gastrointestinal surgery in adults. This observational study compares the AI models predictive performance with commonly used traditional risk scores, such as the Revised Cardiac Risk Index RCRI, ACS NSQIP MICA, and ACS NSQIP Surgical Risk Calculator. The study addresses important questions about whether the AI model can better identify risks in surgical patients by analyzing complex clinical data. The study includes adult patients undergoing gastrointestinal surgery at Bach Mai Hospital. It uses a mixed retrospective and prospective design, collecting data from patients treated in 2025 and those treated prospectively in 2026. The study does not change routine clinical care but reviews medical records and collects clinical information including demographics, medical history, surgical details, laboratory results, electrocardiographic findings, and biomarkers when available. Participants data will be analyzed to predict major cardiovascular events such as cardiovascular death, nonfatal heart attacks, cardiac arrest with recovery, new stroke, and arrhythmias needing treatment within 30 days after surgery. Researchers will assess the AI models discrimination, calibration, and reclassification improvements compared to traditional risk scores during the preoperative period through 30 days post-surgery. The study maintains confidentiality by coding data and focuses on improving risk stratification without altering patient management.

Gastric cancer is a significant health concern worldwide, and surgical removal of the stomach and lymph nodes is the primary treatment option. This research compares the outcomes of laparoscopic total gastrectomy LTG with open total gastrectomy OTG in patients who have locally advanced gastric cancer stages cT2-4a. The trial aims to provide evidence on the technical feasibility, safety, and oncological results of LTG compared to the traditional open surgery. The study involves two surgical approaches LTG, which uses small incisions and specialized instruments to remove the stomach and lymph nodes with a laparoscopic method, and OTG, which involves a larger incision in the abdomen for open surgery. Both approaches include D2 lymph node dissection and reconstruction using the Roux-en-Y method. The LTG procedure requires five trocars and detailed dissection along specific blood vessels and lymph node groups. OTG uses a 15 to 20 cm abdominal incision for the standard total gastrectomy and lymphadenectomy. The trial compares these methods in terms of surgical technique and outcomes. Participants will be evaluated on several measures including 3-year overall survival and relapse-free survival after surgery. Secondary outcomes include operative morbidity and mortality within 30 days, operative time, number of lymph nodes removed, and hospital stay length. The study will monitor patients closely during and after surgery to assess these outcomes. The total participation period includes long-term follow-up to understand survival and cancer recurrence over three years after surgery.

Researchers are evaluating pain control methods for patients undergoing elective open liver resection, a surgery often followed by severe postoperative pain. This trial compares continuous erector spinae plane block ESPB using a programmed intermittent bolus regimen with thoracic epidural analgesia TEA, the current standard, focusing on pain relief, safety, and effects on breathing. The study aims to determine if ESPB is not worse than TEA in controlling pain at rest 72 hours after surgery. Participants will be randomly assigned to two groups. One group will receive bilateral ESPB catheters placed at the T7 level with ropivacaine delivered intermittently every 3 hours for 72 hours. The other group will have a thoracic epidural catheter inserted at T7-T8 with a continuous ropivacaine infusion for 72 hours. Both groups will also receive general anesthesia and systemic pain medications including intravenous paracetamol and nefopam. Treatments and monitoring continue during the 72-hour postoperative period. During the study, participants will have their pain measured at rest and during coughing at multiple time points up to 72 hours after surgery. Researchers will also track morphine use, hemodynamic stability, sleep quality, gastrointestinal recovery, adverse events like nausea or catheter issues, and length of hospital stay. The main result is pain intensity at 24 hours post-surgery. Safety and effectiveness data will be collected until the study ends in August 2026.