Zun Yi Shi

Researchers are evaluating the effectiveness and safety of a drug called B007 in people with generalized myasthenia gravis, a condition that affects muscle strength. This study is a Phase II/III clinical trial designed to compare B007 with a placebo to better understand its impact on daily living activities in affected patients. Participants receive either a high or low dose of B007 or a matching placebo, both given as subcutaneous injections on days 1 and 15. The study includes two groups: those treated with B007 and those given placebo, with treatment administered twice during the trial period. During the study, participants will be monitored for changes in their myasthenia gravis activities of daily living profile (MG-ADL). The main outcome measured is the proportion of participants whose MG-ADL score decreases by 2 or more after approximately 16 weeks. Safety and adherence are also tracked throughout the study.

Researchers are evaluating TQB2102, an antibody-drug conjugate designed to target tumor cells with a potent drug payload, for its effectiveness and safety in treating locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 gene abnormalities. This Phase 2 study focuses on patients whose cancer is either inoperable or has recurred and who have not responded to previous standard treatments. The goal is to assess the overall response rate up to 8 months after starting treatment. Participants may receive TQB2102 alone or in combination with Benmelstobart injection, a monoclonal antibody targeting PD-L1. TQB2102 combines a humanized antibody against HER2 with a topoisomerase I inhibitor payload, aiming to specifically attack cancer cells. The treatments are administered by injection, and the study examines their safety and effectiveness in this patient population. During the study, participants will be monitored closely with evaluations including tumor measurements based on standard criteria. Researchers will track treatment responses and any side effects to determine safety and overall benefit. The study includes adults aged 18 to 75 years with specific performance status and survival expectations, and it also requires contraception use for participants of childbearing potential. The total duration includes baseline through up to 8 months of treatment response assessment.

This research aims to verify the accuracy, stability, and clinical usefulness of artificial intelligence (AI) algorithms for measuring heart function through echocardiography. The study involves collaboration with multiple medical centers and focuses on comparing AI measurements with those done manually by physicians of different experience levels. It also explores whether AI can reduce the time needed for echocardiogram analysis and improve clinical workflows, while assessing AI's performance in complex heart conditions such as cardiomyopathy and valve disease. The study collects echocardiographic data using Mindray ultrasonic machines, with AI and physicians at each center measuring key heart parameters including left and right ventricular size and function. AI and intermediate doctors complete measurements within one day of data collection, while senior physicians at the main research unit finalize their assessments within one month. The goal is to establish a standardized reference system for AI in ultrasound measurement and promote its use across various medical institutions. Participants aged 18 to 80 years with specific heart conditions or normal hearts are involved. Researchers measure heart chamber sizes and functions through echocardiography, comparing AI and physician results for consistency and accuracy. The study also monitors how AI-assisted measurements could optimize diagnosis time and medical resource use. The total duration of participant involvement depends on data collection and measurement timelines, with ongoing analysis to support AI's clinical application in cardiovascular care.

Researchers are conducting a phase I/II clinical trial to study LBL-024 in patients with advanced malignant tumors. This trial aims to assess the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary effectiveness of LBL-024 in patients who have failed standard treatments or for whom no standard treatment is available or applicable. The study includes different phases to explore dose escalation, safety, and efficacy, with a focus on patients with advanced solid tumors. The treatment involves administering LBL-024 by injection every three weeks. The trial is divided into two parts: Part I includes a phase I/IIa dose escalation and pharmacokinetic expansion to evaluate safety and initial efficacy, while Part II is a phase IIb single-arm pivotal study to further assess the treatment in this patient population. Participants will be monitored through various assessments including safety evaluations, pharmacokinetic testing, and measuring tumor response. Key outcomes include determining the maximum tolerated dose, dose-limiting toxicities within three weeks of the first dose, and the objective response rate. Follow-up visits occur 30 days after treatment discontinuation or withdrawal to evaluate ongoing safety and treatment effects. The study requires participants to be adults aged 18 to 80 years with adequate organ function and an expected survival of at least 12 weeks.

This trial evaluates the effectiveness and safety of the GR2001 injection compared to Human Tetanus Immunoglobulin (HTIG) for preventing tetanus. It is a Phase III study focused on patients suspected of tetanus exposure through dirty or contaminated wounds. The study aims to assess the immunogenicity and pharmacokinetics of GR2001 as a potential alternative to HTIG. Participants will receive either the GR2001 injection or HTIG on the first day of the study. GR2001 is provided in a 5mg/1ml vial packaged with specialized materials to ensure safety and stability. HTIG is a licensed human tetanus immunoglobulin derived from human plasma and prepared in injectable form. Both treatments are administered once for tetanus prophylaxis. During the study, researchers will measure the increase in anti-tetanus antibody levels up to 12 hours after treatment to evaluate immune response. Participants must provide informed consent and will be monitored for safety and any adverse reactions. The study includes adults aged 18 and older with suspected tetanus exposure, and the overall participation involves initial treatment and short-term antibody measurement for effectiveness.

Researchers are evaluating how well oral icotrokinra works, its safety, and how well patients tolerate it in adults and adolescents with moderately to severely active ulcerative colitis, a chronic condition where the colon lining becomes inflamed and develops ulcers. This is a Phase 3 study aimed at finding effective treatments for this condition using a rigorous comparison. Participants will receive either icotrokinra tablets or placebo tablets taken by mouth. The study includes an induction phase and a maintenance phase, with adults participating in a randomized, double-blind, placebo-controlled design, while adolescents join an open-label maintenance study. Throughout the study, researchers will monitor clinical remission rates at 12 weeks during induction and at 40 weeks during maintenance. Participants will undergo assessments including endoscopic evaluations and pregnancy tests for females of childbearing potential. Safety and tolerability will be closely observed, with the total study duration covering both induction and maintenance periods.

Researchers are evaluating the effectiveness and safety of pyrrolitinib maleate tablets in treating women with early or locally advanced HER-2-positive breast cancer who have previously received trastuzumab as adjuvant therapy. This study focuses on patients with clinical stage 0-III breast cancer who have completed at least 24 weeks of trastuzumab therapy, with no cancer remaining after surgery and no recurrence of metastatic disease. The trial is a single-arm, multicenter intervention involving adult female participants aged 18 to 75 years. Participants receive 400 mg of pyrrolitinib orally once daily within 30 minutes after breakfast for a total of 52 weeks. Dose adjustments may be made based on adverse reactions, with treatment interruptions allowed for up to 14 days and the use of medications to manage diarrhea permitted. The study does not require makeup doses for missed treatments and monitors participants closely throughout the treatment period. During the study, researchers assess invasive disease-free survival over a maximum of 18 months as the primary outcome. Secondary outcomes include overall survival, disease-free survival, distant metastasis-free survival, and safety evaluations. Participants undergo regular monitoring of blood counts, liver and kidney function tests, cardiac ultrasound, and electrocardiogram to ensure organ health. Participants also provide informed consent and follow contraceptive requirements if not menopausal or surgically sterilized. The total participation duration covers the one-year treatment period and follow-up assessments.

This trial studies patients with limited stage small cell lung cancer who have not shown disease progression after concurrent chemoradiation therapy. It is a randomized, double-blind, phase III clinical study designed to compare the effectiveness and safety of the drug AK112 against a placebo as a consolidation treatment. The goal is to evaluate the potential benefits of AK112 in improving outcomes for these patients. Participants receive either AK112 at a dose of 20 mg/kg or a placebo, both administered intravenously every three weeks (Q3W). The treatment is given as consolidation therapy following initial chemoradiation, aiming to maintain disease control. The study involves two groups: one receiving AK112 and the other receiving placebo, with both treatments delivered under double-blind conditions. Throughout the trial, researchers monitor participants for up to approximately six years, focusing on progression-free survival and overall survival as primary outcomes. Patients undergo regular assessments to track disease status and safety, including blinded independent center reviews. The long-term follow-up ensures comprehensive evaluation of treatment effects and participant safety over time.

Researchers are evaluating the effectiveness and safety of icotrokinra in adults with moderately to severely active Crohn's disease, a chronic condition causing severe inflammation in the intestinal tract. This Phase 2b/3 study aims to understand how well icotrokinra works compared to a placebo in improving symptoms and intestinal healing in this patient group. Participants will receive either icotrokinra or a matching placebo orally every day. The study includes both induction and maintenance phases where researchers assess clinical and endoscopic responses at specific time points, such as Week 12 and Week 40, to determine treatment effects over time. Throughout the study, participants will undergo various assessments including clinical evaluations, endoscopic exams, and safety monitoring. Researchers will measure outcomes like clinical response, clinical remission, and endoscopic healing at Weeks 12 and 40. The study involves regular monitoring to track the participants' health and treatment adherence over the duration of the trial.

Researchers are evaluating pegmolesatide, a long-acting erythropoiesis-stimulating agent (ESA), in patients with renal anemia who are undergoing dialysis and have been treated with hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs). Pegmolesatide was recently approved by the National Medical Products Administration in June 2023. While previous studies showed its safety and effectiveness in dialysis patients previously treated with recombinant human erythropoietin, this trial aims to assess the safety and efficacy of switching from HIF-PHIs to pegmolesatide, as well as to establish dose conversion standards. The study is a multi-center, prospective, open-label, randomized parallel-controlled clinical trial enrolling 96 patients. Participants are divided into low-dose and high-dose Roxadustat cohorts based on their prior weekly Roxadustat dose. Each cohort is further split by hemoglobin levels and then randomized to receive different initial doses of pegmolesatide (2 mg, 4 mg, or 6 mg) administered subcutaneously every four weeks. Treatment lasts for 12 weeks, followed by a 16-week follow-up period. During the study, patients receive regular doses of pegmolesatide with dose adjustments as needed per drug instructions. Researchers will monitor hemoglobin levels from baseline to 12 and 16 weeks to evaluate treatment effects. Throughout the trial, patients undergo assessments to ensure safety and treatment adherence, with overall involvement lasting 28 weeks from the start of treatment to the end of follow-up.