Binh Luc

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.

Researchers are studying AZD0292, a bispecific antibody, to see if it can prevent flare-ups in people aged 12 and older who have bronchiectasis with chronic colonization by Pseudomonas aeruginosa (PsA). This Phase IIb trial compares two different doses of AZD0292 given through intravenous infusion against a placebo. The study mainly focuses on non-cystic fibrosis bronchiectasis patients with frequent PsA-related lung exacerbations, which can worsen lung function, quality of life, and survival. Cystic fibrosis bronchiectasis patients colonized with PsA are also included as an exploratory group. Participants will receive either a high or low dose of AZD0292 or a placebo starting on Day 1 by IV infusion, with additional doses given according to the study schedule. The trial is randomized, double-blind, placebo-controlled, and parallel in design. Treatment effects, safety, and how the body processes the drug will be studied over the course of dosing. During the study, participants will be monitored for lung exacerbations over a follow-up period ranging from 28 to 52 weeks. Researchers will assess lung function, collect airway samples to confirm PsA colonization, and track any side effects or adverse events. The main measure of success is the annualized rate of exacerbations. Participants must adhere to study visits and assessments throughout the trial to help determine the drug’s effectiveness and safety.

Researchers are evaluating the safety and effectiveness of subcutaneous anifrolumab compared with placebo in adults with moderate to severe Idiopathic Inflammatory Myopathies (IIM), specifically polymyositis (PM) or dermatomyositis (DM). This multicenter, randomized, double-blind, placebo-controlled Phase III study adds anifrolumab or placebo to participants' standard of care treatment to assess overall disease activity. Participants will receive weekly subcutaneous injections of either anifrolumab or placebo for 52 weeks. After this period, all participants will receive open-label anifrolumab injections once weekly for an additional 52 weeks. This design allows researchers to evaluate initial treatment effects and longer-term outcomes with anifrolumab. During the study, participants will be monitored regularly for disease activity and safety. The main outcome measured is the Total Improvement Score (TIS) with a response defined as a score of 40 or higher at 52 weeks. The total study participation lasts up to 104 weeks, including the double-blind and open-label extension periods, ensuring comprehensive assessment of the treatment's impact and participant safety.

Researchers are evaluating whether the medicine vicadrostat, combined with empagliflozin, helps adults with chronic heart failure (HF) who have a weakened heart pumping function, specifically a left ventricular ejection fraction (LVEF) below 40%. Eligible participants must have been diagnosed with chronic HF at least 3 months before joining. The study is a Phase III trial designed to compare the effects of vicadrostat plus empagliflozin against placebo plus empagliflozin in people with symptomatic chronic HF classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups. One group takes tablets containing vicadrostat and empagliflozin, while the other group takes placebo tablets that look like vicadrostat along with empagliflozin. Tablets are taken once daily for a period ranging from about 6 months up to about 3.5 years. Participants continue their usual heart failure treatments during the study. The study is double-blind, meaning neither the participants nor the study staff know who is receiving which treatment. During the study, participants regularly visit the study site or may have phone contacts for follow-up. They answer questions about their health and well-being. Doctors monitor and record any worsening of heart failure symptoms, hospital visits due to heart failure, or deaths. They also check participants' overall health and note any side effects. The main outcome measured is the time until a participant experiences cardiovascular death, hospitalization for heart failure, or an urgent heart failure visit, over up to 43 months of follow-up.

Researchers are evaluating an artificial intelligence (AI)-based multimodal model to predict major cardiovascular events within 30 days after gastrointestinal surgery in adults at Bach Mai Hospital. The study also compares this AI model's prediction accuracy with traditional risk scores like the Revised Cardiac Risk Index (RCRI), ACS NSQIP MICA, and ACS NSQIP Surgical Risk Calculator (SRC). The goal is to determine if the AI model better predicts serious heart-related complications after surgery, addressing limitations of current risk scores that may not fully capture complex clinical interactions. This observational study uses a mixed design, collecting retrospective data from patients treated in 2025 and prospective data from those treated in 2026. Participants include adults undergoing gastrointestinal surgery, and the study does not change their routine care. Researchers gather various clinical, laboratory, and surgical data to develop and assess the AI model and traditional scores for predicting events like cardiovascular death, heart attacks, cardiac arrest, stroke, and significant arrhythmias within 30 days after surgery. During the study, researchers review medical records and prospectively collect clinical information while maintaining confidentiality. They measure the AI model's predictive performance using the area under the receiver operating characteristic curve and other statistical methods compared to traditional scores. The study focuses on cardiovascular complications occurring up to 30 days post-surgery, aiming to improve risk prediction and patient outcomes without altering standard perioperative management.

Gastric cancer is a serious health problem worldwide, and surgery is the main treatment option for cure. This research focuses on comparing two surgical methods for treating locally advanced gastric cancer that requires total gastrectomy. While open total gastrectomy (OTG) has been the standard, laparoscopic total gastrectomy (LTG) is being studied for its safety, feasibility, and long-term outcomes, especially since previous trials mainly addressed early-stage cancer and not advanced disease. The study is a prospective randomized controlled trial conducted in settings where many patients are diagnosed at advanced stages and aims to provide evidence on LTG's benefits and risks compared to OTG. Participants receive either laparoscopic gastrectomy or open total gastrectomy for tumors classified as stage cT2-4a without distant metastasis. The laparoscopic procedure uses a minimally invasive approach, while the open surgery follows traditional methods. The study evaluates both short- and mid-term outcomes after surgery, including survival and relapse rates. The surgical experience and technical advances have allowed LTG to become more common, but this trial aims to clarify its role for advanced cases. Participants are monitored over a three-year period to assess overall survival and relapse-free survival after surgery. Researchers will collect data on surgical safety, recovery, and cancer outcomes. Patients must meet specific health criteria and agree to participate with informed consent. This follow-up includes regular imaging and clinical evaluations to track the progress and detect any cancer recurrence or complications, providing important insight into the effectiveness of laparoscopic versus open surgery for gastric cancer.

Researchers are evaluating RBS2418, an immune modulator that inhibits ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) to protect a natural molecule called cGAMP from breakdown. This action aims to activate immune cells and T cells against tumors. The study focuses on adults with advanced, metastatic, and progressive colorectal cancer (CRC) who have not responded to or tolerated standard treatments. The goal is to assess whether RBS2418 is safe, well-tolerated, triggers immune responses, and produces anti-tumor effects compared to a placebo. Participants will be randomly assigned to receive either RBS2418 or a matching placebo alongside best supportive care. Treatments are given in cycles lasting 21 days and may continue for up to two years unless the disease progresses, the participant dies, withdraws, or the study ends. Approximately 150 subjects will join this Phase 2a trial. The study includes monitoring for adverse events during treatment and for up to 90 days after treatment ends, with severity graded according to established criteria. Throughout the study, patients will be regularly assessed for disease progression using scans, and safety will be closely monitored. The main outcomes measured are progression-free survival and overall survival over a period of up to two years. Participants must provide a tissue sample before treatment begins. Adverse events are collected until 30 days post-treatment or until they resolve, and serious events are followed for up to 90 days. This thorough monitoring helps evaluate both the benefits and risks of RBS2418 in this patient population.

Researchers are evaluating the effects of baxdrostat combined with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with systolic blood pressure of at least 130 mmHg at screening, and at least one additional risk factor for heart failure. This Phase III randomized, placebo-controlled, event-driven study aims to determine if the combination reduces the risk of heart failure events or cardiovascular death, with follow-up lasting up to 38 months. Participants who meet screening criteria but are not currently treated with SGLT2 inhibitors or have been treated for less than 4 weeks will enter a run-in period receiving dapagliflozin 10 mg once daily for 4 to 6 weeks before randomization. The study involves random assignment to either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Site visits occur at approximately 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months. Participants discontinuing the blinded study drug may continue open-label dapagliflozin, with ongoing visits and data collection as per protocol. Participants will undergo an optional pre-screening period without site visits or consent to help identify eligibility, followed by up to 14 days of formal screening after informed consent. Researchers will monitor heart failure events and cardiovascular deaths as primary outcomes. Safety and adherence will be tracked throughout the study, including during any premature discontinuation of blinded treatment. The study will conclude when a predetermined number of secondary endpoint events have occurred, with continued follow-up as needed.

Researchers are evaluating the effectiveness and safety of osimertinib tablets combined with Datopotamab Deruxtecan (Dato-DXd) intravenous infusion compared to osimertinib alone as a first treatment for people with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has specific EGFR gene mutations (Ex19del and/or L858R). This global Phase III, open-label, randomized study focuses on participants who have not received prior therapy for advanced disease. The goal is to show that the combination therapy improves progression-free survival compared to osimertinib alone. Participants will be randomly assigned to receive either osimertinib 80 mg orally once daily or osimertinib plus Dato-DXd at 6 mg/kg given by intravenous infusion every three weeks. Treatment will continue until the disease progresses, unacceptable side effects occur, or other reasons require stopping. Visits for assessments will occur every three weeks during treatment. For those on osimertinib alone or who discontinued Dato-DXd but continue osimertinib, visits will be every six weeks from cycle 7 to cycle 17, then every 12 weeks until disease progression or treatment stops. Participants receiving both drugs will have visits every three weeks. During the study, participants will undergo regular assessments including scans and laboratory tests to monitor their condition and treatment effects. Researchers will track progression-free survival through independent review about three years after the first participant is enrolled. The study is expected to last about eight years, with ongoing monitoring of safety and treatment tolerance throughout. Participants must attend scheduled visits for evaluations and treatment administration as outlined in the study plan.

Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) combined with Rilvegostomig or Rilvegostomig alone compared to Pembrolizumab alone as first-line treatments for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Participants must have high PD-L1 expression (tumor cells 50% or greater) and no actionable genetic changes. This Phase III, randomized, open-label global study focuses on this specific group of lung cancer patients without known targetable mutations. The trial includes three treatment groups: one receiving Dato-DXd plus Rilvegostomig intravenously, one receiving Rilvegostomig alone intravenously, and one receiving Pembrolizumab alone intravenously. Treatments are given as first-line therapy, meaning participants have not received prior systemic treatment for advanced disease. The study compares these treatments to assess their effect on cancer progression and survival. Participants will be closely monitored throughout the study, which includes assessments of progression-free survival over about four years and overall survival over about six years. Researchers will collect tumor samples to confirm PD-L1 and TROP2 status, perform scans to measure tumor response, and evaluate organ function and performance status. Safety and side effects will be tracked to understand treatment tolerability. The entire participation duration may extend up to several years to capture long-term outcomes.