Nan Tong Shi

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 evaluating the effectiveness and safety of zonisamide as an additional treatment for children aged 1 to 14 years with focal epilepsy, including those with secondary generalized tonic-clonic seizures. The study aims to determine whether zonisamide can reduce the frequency of epileptic seizures and improve cognitive function, while also monitoring any treatment-related side effects. This open-label, observational study focuses on patients who have not achieved adequate seizure control with one antiepileptic drug. Participants will receive zonisamide tablets orally, starting at 2 mgkgday during the first two weeks. The dose increases to 4 mgkgday in weeks 3-4 and to 6 mgkgday in weeks 5-6. After six weeks, the dose is adjusted weekly by 1 mgkgday based on the patients condition, maintaining a dose between 4 and 6 mgkgday given once or twice daily. Children weighing 50 kg or more will receive adult-equivalent dosing. During the study, participants seizure frequency and cognitive function will be assessed at baseline, week 8, and week 20. Safety will be monitored through physical exams, vital signs, weight checks, and laboratory tests including liver and kidney function and blood counts. The study will use statistical software to analyze changes in seizure frequency and safety data. The total study duration is from August 1, 2024, to July 31, 2027.

Researchers are evaluating the efficacy and safety of elecoglipron, an oral tablet taken once daily, for weight management in adults with obesity or overweight. This Phase III global, randomized, double-blind, placebo-controlled trial includes two independent pivotal studies one in adults without type 2 diabetes T2DM and the other in adults with T2DM, all having at least one weight-related health condition. The goal is to understand how elecoglipron compares to placebo when combined with diet and exercise. Participants will be randomly assigned to receive either one of two doses of elecoglipron or a matching placebo daily. Study 1 involves about 3000 adults living with obesity or overweight without T2DM, while Study 2 involves about 1500 adults with obesity or overweight and T2DM. Both studies last 72 weeks, during which changes in body weight and other health measures will be monitored. During the trial, participants will undergo regular health assessments including measurements of body weight, waist circumference, blood sugar control, blood pressure, and other related health indicators. Researchers will track percent change in body weight from baseline at 72 weeks as the primary outcome. Participants will be monitored closely throughout the study to assess safety and effectiveness of the treatment in managing weight and associated health conditions.

Researchers are conducting a real-world study to evaluate the impact of iptacopan on adult patients with paroxysmal nocturnal hemoglobinuria PNH in China. The study aims to assess treatment-related outcomes, disease management, and healthcare resource use, considering new standards for PNH care and the introduction of iptacopan. It includes patients who are either new to complement inhibitor therapy or those stable on C5 complement inhibitors like eculizumab. The study involves two patient groups one with PNH patients never treated with complement inhibitors who are starting iptacopan, and another with patients stable on C5 complement inhibitors who will switch to iptacopan after its approval in China. Treatments are oral capsules of LNP023 iptacopan, and patients must start iptacopan within 60 days of consenting. Participants must have documented vaccinations against Neisseria meningitidis and Streptococcus pneumoniae before starting treatment. Participants will be followed for at least 12 months, with assessments including hemoglobin levels, lactate dehydrogenase LDH, absolute reticulocyte count ARC, bilirubin, PNH clone size, and signs or symptoms related to PNH. Researchers will monitor treatment effects, adverse events, medication use, transfusions, and healthcare visits. Patient fatigue and work productivity will be evaluated using specific questionnaires, with data collected at baseline and regular intervals to understand iptacopans real-world impact on disease and quality of life.

Researchers are conducting a multicenter, non-interventional, descriptive study to collect and analyze solid tumor samples from patients with non-small cell lung cancer NSCLC, biliary tract cancer BTC, gynecological cancers GYN, and urothelial carcinoma UC. The study aims to assess the agreement between different HER2 immunohistochemistry IHC assays and the interpretation consistency among pathologists. This study involves about 2100 patients diagnosed between January 2023 and September 2025 from 12 sites. The study has two phases enrollment and assessment. During enrollment, approximately 2100 patients are retrospectively collected and tested for HER2 status using the Roche 4B5 assay at local labs. A committee reviews and aligns these results. In the assessment phase, 320 patients are selected based on HER2 expression levels to evaluate assay performance and interpretation concordance. Tissue samples are sectioned into at least 15 slides for various assays, including Roche 4B5 and HercepTest, with results reviewed by pathologists. Digitalized slides are interpreted by 36 trained pathologists to evaluate inter-observer agreement. Participants archived tumor tissues are analyzed with multiple assays, and interpretation results are compared to assess agreement. The study measures include positive and negative percent agreement of HER2 IHC assays and inter-observer concordance across different HER2 expression levels. The assessment phase and interpretation evaluations last up to approximately six months. This study does not involve treatment but focuses on comparing testing methods and interpretation consistency for HER2 status in these cancers.

Researchers are evaluating whether combining pelabresib with ruxolitinib improves clinical outcomes compared to ruxolitinib alone in adults with primary myelofibrosis PMF, post-polycythemia vera myelofibrosis PPV-MF, or post-essential thrombocythemia myelofibrosis PET-MF who have not previously been treated with Janus kinase JAK inhibitors. This Phase 3 trial focuses on participants with intermediate or high-risk disease and assesses symptom burden and spleen size among other clinical measures. Participants begin with a screening period lasting up to 28 days to confirm eligibility and complete baseline tests. During the treatment phase, they are randomly assigned to receive either pelabresib orally once daily for 14 days of each 21-day cycle plus continuous ruxolitinib twice daily, or a matching placebo plus ruxolitinib. Treatment continues until unacceptable side effects, disease progression, or withdrawal. After treatment, a 30-day safety follow-up monitors for late side effects. Participants who have not experienced disease progression enter an efficacy follow-up with visits every 12 weeks for ongoing assessments including spleen imaging, lab tests, and bone marrow biopsies. Those with progression or new therapy start survival follow-up visits every 12 weeks, which may be remote, to monitor overall survival and disease status. The study includes comprehensive symptom scoring and spleen response evaluations over approximately three years.

Researchers are evaluating YL201, a drug being studied for men with metastatic castration-resistant prostate cancer mCRPC, in an open-label, multicenter phase II trial in China. The study aims to assess the safety, effectiveness, and how the body processes YL201 in this patient group. This research includes patients who have progressed despite prior hormone therapies and may have received limited chemotherapy. The study is sponsored by MediLink Therapeutics Suzhou Co., Ltd. Participants will receive YL201 through intravenous infusion every three weeks, with dosing schedules varying between once or twice per cycle depending on the group. There are multiple dosing cohorts testing different amounts and frequencies of YL201 to find the best dose for future studies. The trial includes about 100 patients divided into initial groups receiving specific doses and a later group receiving the recommended dose and administration method. During the study, participants will undergo regular assessments including imaging scans to measure tumor response and progression, blood tests to monitor drug levels and side effects, and evaluations of prostate-specific antigen PSA levels. Researchers will track objective response rates, progression-free survival, and safety outcomes over approximately 36 months. Tumor tissue analysis for B7H3 expression and monitoring for adverse events will also be part of the study. Participants must comply with scheduled visits and procedures throughout the trial.

Researchers are evaluating the efficacy, safety, and tolerability of combining elecoglipron and dapagliflozin compared to each drug alone in adults with type 2 diabetes mellitus T2DM who have not achieved adequate control through lifestyle changes or other glucose-lowering medications. This Phase III study aims to better understand how these treatments work together in managing blood sugar levels in this population. Participants are randomly assigned to one of five groups two groups receive elecoglipron at different dose levels combined with dapagliflozin two groups receive elecoglipron at different dose levels combined with a placebo matching dapagliflozin and one group receives dapagliflozin alone with a placebo matching elecoglipron. All medications are taken orally once daily. The treatment period lasts 40 weeks, during which the effects of the drugs on blood sugar and other health measures will be monitored. Throughout the study, participants will have regular assessments of their blood sugar control, body weight, and blood pressure. Researchers will measure changes in Hemoglobin A1c HbA1c, fasting plasma glucose, and self-monitored blood glucose levels. Other outcomes include weight loss and the need for rescue medication. Safety and tolerability will be closely monitored. Participation in the trial lasts for 40 weeks, during which participants will attend scheduled visits for evaluation and medication monitoring.

Researchers are comparing two treatment combinations for elderly patients with newly diagnosed multiple myeloma who are not planning to have a stem cell transplant initially. The study evaluates the safety and effectiveness of daratumumab, lenalidomide, and dexamethasone DRd versus a modified combination of bortezomib, lenalidomide, and dexamethasone VRd-lite. The main goals are to see which treatment better delays disease progression and achieves a negative minimal residual disease status. Participants can choose between the two treatments. Daratumumab is given through weekly intravenous infusions initially, then less frequently over several months, combined with oral lenalidomide and dexamethasone taken on specific days in 28-day cycles. The alternative group receives bortezomib injections weekly with the same oral medications on a similar schedule. After the initial treatment cycles, maintenance therapy continues with lenalidomide alone or combined with daratumumab or bortezomib based on risk assessment until disease progression or unacceptable side effects occur. During the study, participants will be regularly monitored for disease progression and safety, with evaluations including progression-free survival and minimal residual disease negativity measured at multiple timepoints over approximately five years. Additional response rates and overall survival will also be tracked. Safety assessments continue throughout the study to ensure participant well-being during treatment and follow-up.

Researchers are evaluating the real-world effectiveness of Repatha combined with standard of care SOC compared to SOC alone in Chinese adults with established atherosclerotic cardiovascular disease ASCVD. The study focuses on the risk of major cardiovascular events such as cardiovascular death, heart attack, stroke, hospitalization for unstable angina, or coronary revascularization. This observational study aims to understand how these treatments work when used according to local clinical practice. Participants are divided into two groups based on treatment decisions made independently of the study enrollment those receiving Repatha with SOC and those receiving SOC alone. The study observes these participants over a period of up to 72 months to assess outcomes. Treatment choices follow local guidelines and approved labels, ensuring minimal impact on routine care. During the study, participants undergo regular monitoring for cardiovascular events and changes in cholesterol levels, including low-density lipoprotein cholesterol LDL-C. Researchers also track adverse events and reactions throughout the follow-up period. Participants remain under usual care, and data collection occurs alongside routine clinical visits, with a total participation time of up to six years.