Cheng Du Shi

Researchers are studying patients with low-risk intermediate-stage nasopharyngeal carcinoma who have responded well to induction chemotherapy and have undetectable levels of plasma EBV-DNA. The trial compares two doses of radiotherapy targeting a specific low-risk area to evaluate their effects on survival, side effects, and quality of life. This phase 3 randomized study aims to find out if lower-dose radiotherapy can maintain treatment success while reducing toxicities related to treatment. Participants receive either reduced-dose radiotherapy 40.2Gy or conventional-dose radiotherapy 49.2Gy to the low-risk target volume called CTV2. Both groups undergo full-course immunotherapy with the PD-1 monoclonal antibody Tislelizumab, administered every three weeks, totaling 12 courses through induction, radiotherapy, and maintenance phases. Induction chemotherapy using a cisplatin-based regimen is given before radiotherapy. Treatment continues until toxicity, progression, withdrawal, or completion of planned courses. During the study, patients will be monitored for progression-free survival and serious adverse events over three years. Secondary measures include metastasis-free survival, relapse-free survival, overall survival, tumor response rates, and quality of life assessments using standard questionnaires over three years. Safety and effectiveness will be evaluated through imaging, laboratory tests, and clinical evaluations. The study enrollment includes adults aged 18 to 75 years, and the follow-up will provide information on long-term outcomes and treatment impact.

Researchers are investigating the early brain regions involved in Alzheimers disease and its precursors using novel molecular probes 18FAV45 Ab2 and 18FAV1451 Tau with PETCT imaging. This study aims to understand the distribution of positive brain lesions affecting mental state tests like the simple mental state examination and the Montreal Cognitive Assessment Scale in Alzheimers patients. The goal is to provide molecular imaging information that may help study Alzheimers disease mechanisms and establish objective diagnostic criteria for early detection. The study uses new imaging agents Ab2 and Tau PETCT, which can detect pathological changes at the molecular level before symptoms appear. These molecular probes offer earlier and more visual detection of Alzheimers disease-related changes, helping to define positive diagnostic criteria for early Alzheimers disease. Participants include groups with mild cognitive impairment, Alzheimers disease, and healthy volunteers. Participants will be assessed through PETCT imaging using these molecular probes to observe brain pathology. Researchers will evaluate the diagnostic criteria for Ab2 and Tau imaging within two months. The study includes cognitive tests and clinical dementia rating scales. This observational study involves healthy volunteers and patients with mild cognitive impairment or Alzheimers disease, aiming to improve early diagnosis through imaging techniques.

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 Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rilzabrutinib in adults with active Immunoglobulin G4-related disease IgG4-RD. The study aims to measure the time to the first adjudicated disease flare and assess other important outcomes such as flare-free rates, disease activity control, glucocorticoid use, and safety parameters including adverse events, laboratory tests, and electrocardiograms ECG. Participants will be assigned to one of two groups one receiving rilzabrutinib tablets and the other receiving placebo tablets, both administered orally. The treatment period lasts 52 weeks in a double-blind manner, preceded by a 4 to 6 week screening period. After treatment, there is a 2-week follow-up, with an optional open-label extension lasting up to 108 weeks. The study includes a total of 16 visits during the main period and up to 9 additional visits during the optional extension. During their participation, adults diagnosed with IgG4-RD will undergo repeated imaging procedures such as CT, MRI, PET, or ultrasound to assess disease status. Researchers will monitor disease flares, remission status, glucocorticoid dosage, clinical activity scores, laboratory values, vital signs, and ECG results. Safety monitoring continues up to week 160 to capture treatment-emergent adverse events. Overall, participation lasts up to 60 weeks, with possible extension for those continuing in the optional phase.

Researchers are evaluating the pharmacokinetic properties and safety of a drug called AHB-137 injection in adults aged 18 to 65 years who have mild to moderate liver dysfunction as well as those with normal liver function. This study is designed as a Phase 1 clinical trial to better understand how the drug behaves in these different groups and to assess any potential safety concerns. It is sponsored by Ausper Biopharma Co., Ltd. and involves participants with chronic hepatitis B. Participants receive a single subcutaneous injection of AHB-137. The study includes two groups of participants with liver dysfunction classified as Child-Pugh A and Child-Pugh B, along with matched groups of participants with normal liver function. The groups are studied in parallel, and the trial compares how the drug is processed in their bodies. The dosing involves only one administration, and the study duration extends up to 29 days for monitoring. During the study, participants undergo various assessments to measure pharmacokinetic parameters, including peak concentration and drug exposure over time area under the curve up to day 29. Safety indicators are also monitored throughout this period. Participants may have physical exams, laboratory tests, and other procedures to ensure safety and collect data on the drugs behavior. The total participation time lasts up to 29 days following the injection.

This research aims to assess the safety, tolerability, and initial effectiveness of JWK008 injection in adults with Mucopolysaccharidosis Type I MPS I, a rare genetic disorder caused by a deficiency of the IDUA gene enzyme. Current treatments have limitations, particularly in treating effects on the central nervous system. This study investigates a novel gene therapy designed to cross the blood-brain barrier and target liver tissue to deliver therapeutic effects to the brain and body. Participants will receive a single intravenous infusion of JWK008 at one of two doses 5.01012 or 2.01013 vector genomes per kilogram of body weight. The study uses a dose-escalation design to monitor safety and responses in small groups of participants. This is an open-label trial without a placebo group, focusing on evaluating this gene therapys effects over time. During the five-year follow-up, researchers will monitor adverse events and measure enzyme activity and glycosaminoglycan levels in blood, urine, and cerebrospinal fluid. Participants will also undergo physical tests like the Six-Minute Walk Test and joint motion assessments, as well as imaging studies to evaluate liver and spleen size. Vector shedding will be tracked to understand how the gene therapy is processed. This long-term monitoring aims to evaluate safety and biological effects comprehensively.

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 effectiveness and safety of B007 in people with generalized myasthenia gravis, a condition that causes muscle weakness. This randomized, double-blind, placebo-controlled Phase IIIII study aims to understand how well B007 works compared to a placebo in improving daily living activities affected by this condition. Participants will receive either a high or low dose of B007 or a matching placebo through subcutaneous injections on days 1 and 15. The study includes careful monitoring over approximately 16 to 24 weeks to assess changes in symptoms and quality of life, with a safety follow-up lasting about one year. During the trial, participants will be evaluated through various measures including the Myasthenia Gravis-Activities of Daily Living profile, quality of life questionnaires, and composite scores related to the condition. Researchers will also track any side effects or adverse events. The total participation time varies, with key assessments occurring around 16 to 24 weeks and safety monitored for about a year.

Researchers are evaluating the efficacy and safety of a drug called B007 in adults with pemphigus, a condition characterized by blistering of the skin and mucous membranes. This Phase IIIII clinical trial is designed to understand how well B007 works to achieve remission with minimal treatment and to monitor its safety in this patient population. Participants will receive B007 through subcutaneous injections administered on days 1 and 15. The study measures include the proportion of patients achieving complete remission, partial remission, changes in the Pemphigus Disease Area Index PDAI, frequency of disease relapses, duration of response, and incidence of treatment-emergent adverse events. The treatment period and follow-up assessments extend up to approximately one year. During the trial, participants will be closely monitored through scheduled visits to assess disease activity and treatment response. Outcomes such as remission rates and relapse frequency will be tracked, along with safety evaluations for any adverse effects. The total participation duration includes about one year of observation after treatment initiation to fully capture treatment effects and safety data.

Researchers are evaluating if combining the medicines calderasib and subcutaneous pembrolizumab can more effectively treat people with non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study aims to find out whether patients receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a Phase 3 clinical trial focusing on first-line treatment for advanced or metastatic nonsquamous NSCLC. Participants are assigned to one of two groups. One group receives subcutaneous pembrolizumab plus berahyaluronidase alfa every 6 weeks for up to 18 cycles about 2 years along with oral calderasib until treatment discontinuation criteria are met. The other group receives the same pembrolizumab and berahyaluronidase alfa regimen plus chemotherapy with pemetrexed and either carboplatin or cisplatin infusions during the early cycles. Treatment continues based on individual response and tolerability. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess progression-free survival, overall survival, response rates, and quality of life using questionnaires and symptom scores over several years. Safety will be monitored through adverse event reporting. The trial lasts up to about 7 years with ongoing evaluation of health outcomes and side effects to understand the impact of these treatment combinations.