Fu Xin Shi

Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary effectiveness of WJB001 capsules in adults with advanced solid tumors. This phase I/II trial includes patients who have advanced malignant solid tumors that are resistant or intolerant to standard treatments. The study aims to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended phase II dose (RP2D) through dose escalation, dose expansion, and efficacy expansion phases. The study treatment involves oral WJB001 capsules at a dose of 160 mg or other dosages, taken once daily on days 1-5, 8-12, 15-19, or other dosing schedules every 21 days. The first phase uses accelerated titration and a "BOIN" combination method for dose escalation. The dose expansion phase selects 1 to 2 doses based on previous data to further assess safety, tolerability, efficacy, and pharmacokinetics. The efficacy expansion phase plans to use the Simon two-stage optimal method to expand 2 to 3 patient cohorts. Participants will go through screening, treatment, and follow-up periods. During the study, researchers will monitor dose-limiting toxicity within 21 days, adverse events and serious adverse events over 3 years, maximum tolerated dose and recommended phase II dose over 2 years, and objective response rate over 3 years. Assessments include physical exams, laboratory tests, imaging for tumor measurements, and safety evaluations to track treatment effects and participant health throughout the study.

Researchers are evaluating the safety and effectiveness of QD202 injection in patients who have experienced an acute ischemic stroke and are undergoing thrombolysis, but not endovascular thrombectomy. This is a Phase II randomized, double-blind, placebo-controlled study involving up to 120 male and female participants aged 18 to 85 years. The trial aims to measure safety and tolerance over an average of 90 days following treatment. Participants will receive either QD202, a 19 amino acid peptide designed to cross the blood-brain barrier, or a matching placebo. The assigned treatment is given as a 60-minute intravenous infusion after completing the thrombolysis procedure, during the first five days of the study. Follow-up assessments take place on Day 7 or at discharge, Day 30, and at the study's end on Day 90. Throughout the study, participants will undergo neurological evaluations and safety monitoring, including clinical assessments related to stroke recovery. Researchers will collect data on treatment safety and how well patients tolerate the infusion. The total involvement period for each participant is approximately 90 days, allowing for careful observation and measurement of outcomes after the intervention.

Researchers are evaluating the efficacy and safety of Yangxinshi tablets in patients with coronary heart disease complicated by cardiac dysfunction. This Phase 4 randomized controlled trial aims to determine whether adding Yangxinshi tablets to conventional treatment can reduce ischemic or heart failure-related clinical events, improve exercise tolerance, and enhance quality of life and mental health in these patients. The study includes 2708 patients aged 40 to 80 years with specific heart conditions and symptoms. Participants are randomly divided into two groups: one group receives conventional treatment plus Yangxinshi tablets (3 tablets, three times daily), while the control group receives only conventional treatment without additional tablets. Conventional treatment includes drugs such as aspirin, beta-blockers, statins, and others aimed at improving outcomes and relieving symptoms. The treatment continues until the expected number of endpoint events occurs or the study ends. During the study, participants are monitored for ischemic events or heart failure-related clinical events, including death, stroke, myocardial infarction, and hospital readmissions. The average follow-up period is about three years. Researchers assess exercise tolerance, quality of life, and mental health, while monitoring safety and overall health status throughout the study.

Researchers are evaluating treatments for adults with acute spontaneous supratentorial intracerebral hemorrhage (ICH) of 20 mL or more. The study compares early minimally invasive surgery combined with thrombolysis (eMIST) against the best medical management. This multicenter trial is designed to adaptively assess outcomes using a randomized, open-label approach with blinded evaluation of results. The main goal is to improve functional recovery measured by a utility-weighted modified Rankin Scale at 180 days after treatment. Participants are randomly assigned to one of two groups: one receiving early minimally invasive catheter evacuation surgery along with up to ten doses of urokinase administered through the catheter placed in the hemorrhage area, and the other receiving the best available medical care without surgery. The intervention must start within 4 hours after randomization, which itself must occur within 8 hours of stroke symptom onset or the last known well time. The study includes an adaptive design to reassess sample size after 250 patients complete 180-day follow-up. Throughout the study, patients undergo assessments including head CT scans before randomization to confirm eligibility. Functional improvement is tracked using the utility-weighted modified Rankin Scale at 180 days. Safety and effectiveness of treatments are monitored during the trial, which includes long-term follow-up to evaluate outcomes. Participants or their legal representatives provide informed consent prior to enrollment.