Shen Yang Shi

Researchers are evaluating the use of three-dimensional magnetic resonance elastography 3D MRE to measure tumor stiffness and adhesion in patients with meningioma scheduled for surgical removal. This study aims to see if 3D MRE can serve as a noninvasive imaging tool to help surgeons plan operations, assess risks, and predict tumor behavior by comparing MRE findings with what surgeons observe during surgery and with pathological analysis after surgery. Participants will receive standard brain MRI along with additional 3D MRE scans before surgery. The 3D MRE uses vibrations and special software to create maps showing tumor stiffness and adhesion, which are shared with the neurosurgical team. During surgery, doctors will record tumor texture, adhesion, blood supply, and difficulty of removal to compare with the MRE results. Participants involvement includes preoperative MRI and MRE scans, surgery with detailed recording of tumor characteristics, and postoperative pathological analysis of tumor samples. Researchers will analyze how well MRE measurements match the surgical and histological findings. The main outcome is measuring agreement between MRE stiffness and tumor texture observed during surgery. The study is expected to continue until 2027, involving about 300 participants aged 18 to 80 years.

Researchers are investigating new non-invasive methods to predict hepatic venous pressure gradient HVPG, a key measure in managing portal hypertension in cirrhosis. This study compares three-dimensional magnetic resonance elastography 3D-MRE with two-dimensional magnetic resonance elastography 2D-MRE to develop a risk stratification system that can guide personalized treatment for portal hypertension. Cirrhosis and portal hypertension pose significant health challenges, making less invasive diagnostic tools important for patient care. Participants will undergo imaging using either 3D-MRE or 2D-MRE, both performed on a 3.0-T MRI system with an eight-channel body coil. The study features two groups one developing a model using 3D-MRE and a control group using 2D-MRE. Hepatic venous pressure gradient measurements are taken by trained radiologists following standard procedures. Comparing these imaging techniques aims to evaluate their accuracy in assessing portal hypertension. During the study, participants will have imaging and HVPG measurements within one month to ensure data consistency. Researchers will assess the accuracy of 3D-MRE and 2D-MRE features for predicting portal hypertension over a 12-month period. The study monitors participants through these diagnostic tests and evaluates how well the imaging models can predict HVPG, contributing to safer, more convenient management of cirrhosis-related complications.

Researchers are evaluating a new, non-invasive method using three-dimensional magnetic resonance elastography 3D-MRE to predict hepatic venous pressure gradient HVPG in patients with cirrhosis, portal hypertension, or advanced chronic liver disease. This study aims to establish a risk stratification system to better manage portal hypertension, a critical factor affecting the prognosis of these liver conditions. The trial is observational and focuses on improving diagnosis without invasive procedures like liver biopsy or traditional HVPG measurement. The study involves two groups a training cohort to develop the new 3D-MRE model for virtual HVPG prediction, and a validation cohort to confirm the models accuracy in different patients under similar conditions. Imaging is done using a 3.0-T MRI system with a phased-array body coil, while HVPG measurements are performed by skilled interventional radiologists following standard procedures. Participants undergo both assessments within one month. During the 12-month study, participants will have their portal hypertension assessed through the features of 3D-MRE and HVPG readings. Researchers will analyze the accuracy of 3D-MRE to predict portal hypertension levels. Participants provide informed consent and meet age and health criteria. The study includes monitoring to ensure reliable imaging and measurement results, with exclusion of those with conditions or treatments that may affect accuracy. The total participation involves these diagnostic steps, with no treatment interventions administered.

Researchers are evaluating BLU-5937, an oral drug, in adults with refractory chronic cough, including unexplained chronic cough, in a randomized, double-blind, placebo-controlled Phase 3 study. The main goal is to assess how BLU-5937 affects 24-hour cough frequency over 24 weeks. This study also monitors safety by tracking adverse events and changes in various health parameters during the treatment period. Participants are randomly assigned to one of three groups BLU-5937 25 mg twice daily, BLU-5937 50 mg twice daily, or a matching placebo taken twice daily. The treatment lasts for 24 weeks, and participants receive their assigned oral medication regularly throughout this time. The study uses a parallel-arm design and includes an extension in China. During the study, participants undergo assessments including cough frequency measurement, vital signs, blood tests for hormones and chemistry, hematology, and ECGs at baseline and Week 24. Researchers also evaluate cough severity and quality of life using questionnaires. Safety is closely monitored by recording adverse events, treatment discontinuations, and laboratory changes. The total participation duration is 24 weeks, with follow-up assessments at specified intervals.

Researchers are conducting a long-term follow-up study of adults with newly diagnosed or relapsed Graves disease at the First Affiliated Hospital of China Medical University. The study aims to determine relapse and remission rates after drug treatment, identify risk factors for relapse, evaluate the effects and side effects of different doses of methimazole, and investigate the diagnostic and predictive value of TRAb. They also analyze changes in serum alkaline phosphatase related to methimazole treatment and thyroid function. Participants receive methimazole treatment with dosages adjusted according to established guidelines. During outpatient follow-ups, thyroid and liver function tests, TRAb levels, and blood counts are performed to monitor treatment effects and side effects such as liver injury and leukopenia. The study assesses the sensitivity and specificity of TRAb in diagnosis and recurrence prediction, and tracks biochemical changes over time. Over a period of up to 30 years, participants will be regularly monitored through clinical evaluations and laboratory tests to assess their disease status, treatment outcomes, and adverse effects. The research team will collect data on relapse, remission, and drug safety to develop risk prediction tools and better understand Graves disease management. The study includes long-term observation and safety monitoring throughout the follow-up.

Researchers are evaluating anti-HER2-CAR-T cell therapy in adults aged 18 to 70 years with HER2-positive locally advanced or metastatic solid tumors, including breast, gastric, colorectal, and pancreatic cancers. This Phase 1, open-label study aims to assess the safety and effectiveness of this cellular treatment when conventional options have been ineffective or are not tolerable. The trial is sponsored by China Medical University, China. Participants receive a single intravenous infusion of anti-HER2-CAR-T cells at varying doses based on a dose escalation design, with possible additional infusions decided by the investigator. Before infusion, patients undergo lymphocyte clearance treatment using cyclophosphamide and fludarabine. Treatment dosing groups include 1x106, 3x106, or 1x107 CAR-T cells per kilogram, and the infusion dose refers to the count of CAR-positive cells. During the study, participants will have an initial screening period, mononuclear cell collection, and may receive bridging therapy if needed before treatment. Researchers will monitor safety by tracking dose-limiting toxicities within 21 days post-infusion and evaluate tumor responses at multiple timepoints up to 12 months. Assessments include imaging for measurable lesions, blood tests, and overall health status. The study includes close follow-up and may last until October 2026.

Researchers are evaluating the effectiveness and safety of B001 injection in patients who have neuromyelitis optica spectrum disorder NMOSD and test positive for aquaporin-4 antibodies. This condition involves recurrent attacks affecting the nervous system. The study is a multicenter, randomized, double-blind, placebo-controlled trial conducted in phases II and III to understand how well B001 works and how safe it is for these patients. Participants will receive intravenous doses of either B001 or a placebo on Day 1 and Day 15 during the randomized controlled period. The study includes two groups one receiving B001 injections and the other receiving placebo injections matching B001s schedule. The trial will extend over several years, monitoring patients closely for disease relapse and treatment side effects. During the study, participants will be regularly assessed for the time to their first NMOSD attack, changes in disability status, vision acuity, and opticospinal function. Researchers will also observe the annual relapse rate and document any adverse events. The trial includes safety monitoring for about three years to ensure comprehensive data collection on treatment impact and participant health.

Researchers are evaluating the safety and effectiveness of a drug called B007 compared to cyclosporine in treating adults with primary membranous nephropathy, a kidney condition. This study is a multicenter, randomized, controlled, open-label trial conducted in phases II and III to better understand treatment options for this disease. Participants will be randomly assigned to receive either B007 or cyclosporin capsules. B007 is given by subcutaneous injection on days 1 and 15, while cyclosporin capsules are taken orally at a dose of 3.5 mg per kg of body weight per day. The study will observe participants over about two years to assess remission rates and monitor safety. During the trial, participants will undergo laboratory tests and assessments to track overall, complete, and partial remission rates. Researchers will also monitor any treatment-emergent adverse events or serious side effects. Participants must meet specific kidney function criteria and will be followed closely throughout the study period until its completion in late 2026.

Researchers are conducting a Phase 1, open-label, multicenter clinical study to evaluate the safety, pharmacokinetics, and preliminary efficacy of HMPL-506 in patients with hematological malignancies. The study focuses on patients with specific genetic alterations in blood cancers, including relapsed or refractory Acute Myeloid Leukemia AML, Acute Lymphocytic Leukemia ALL, and multiple myeloma MM. The trial is sponsored by Hutchmed and aims to enroll between 60 and 132 patients across two phases dose escalation and dose expansion. In the dose escalation phase, approximately 30 to 38 patients with MLL-rearranged andor NPM1-mutant relapsedrefractory AML or ALL will receive escalating oral doses of HMPL-506 once daily. Starting at 50 mg, doses may increase based on safety, efficacy, and pharmacokinetic data, with adjustments guided by a Safety Monitoring Committee. The dose expansion phase will enroll about 30 to 60 patients divided into three cohorts based on specific genetic markers or disease type. Patients in this phase will receive the recommended phase 2 dose in 28-day cycles until disease progression, unacceptable toxicity, or other study endpoints. Participants will undergo regular assessments including bone marrow aspiration and biopsy, safety monitoring for dose-limiting toxicities and adverse events, and evaluations of anti-tumor efficacy every treatment cycle. Pharmacokinetic and pharmacodynamic analyses will be conducted, along with electrocardiograms and laboratory tests. Safety follow-up will continue up to 42 months after the last dose. The study includes monitoring for serious adverse events and overall survival, with participants remaining under medical supervision throughout the trial duration.

Researchers are conducting an open, multicenter Phase III clinical trial to study HRS-8364 in adults with advanced solid tumors. The study aims to evaluate the safety, tolerability, pharmacokinetics, and effectiveness of HRS-8364 in patients whose cancer has progressed despite standard treatments or who have no standard treatment options. This trial is sponsored by Jiangsu HengRui Medicine Co., Ltd. Participants will receive HRS-8364 tablets at various doses through different stages of the study dose escalation, dose expansion, and efficacy expansion. The trial will assess the best dose for further study, monitor side effects, and evaluate the drugs impact on tumor response. Treatment and follow-up will last about one year, with close monitoring of drug levels and patient health. During the trial, participants will undergo regular assessments including evaluations of tumor size based on RECIST criteria, safety checks, and blood tests to monitor drug concentration and effects. Researchers will track outcomes like dose-limiting toxicity, response rates, disease control, and progression-free survival. The study includes safety follow-up and requires participants to comply with contraception guidelines if applicable, lasting from enrollment through about one year of treatment and follow-up.