Changzhi

Researchers are evaluating the effects of adding SG301 injection to pomalidomide and dexamethasone in adults with relapsed or refractory multiple myeloma who have had at least one prior treatment including lenalidomide and a proteasome inhibitor. This phase III, randomized, placebo-controlled, double-blind study aims to compare SG301 combined with pomalidomide and dexamethasone against placebo combined with these drugs. The study includes two stages: a dose exploration phase to determine the recommended dose of SG301, followed by a randomized controlled phase to assess treatment outcomes. Participants will receive SG301 or placebo as an intravenous infusion weekly for 8 weeks, then every two weeks thereafter. All participants will take pomalidomide capsules orally at 4 mg once daily on days 1 through 21 of each 28-day cycle. Dexamethasone will be given orally or intravenously at 40 mg on days 1, 8, 15, and 22 of each 28-day cycle, with a reduced dose for participants with low body mass index. The study treatment continues through these cycles, with dosing and treatment monitored carefully. Participants will be monitored for adverse events from the first dose through about 30 days after the last dose, with follow-up lasting up to approximately 4 years. Disease progression and survival will be tracked regularly, with assessments every 4 weeks initially and then every 8 weeks after randomization. The study includes evaluations of organ function, disease status, and safety to gather comprehensive data on the treatments' impact and participant well-being throughout the trial period.

This study is a multicenter, open-label, phase I/II study of YL205 in China to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of YL205 in the following selected patients with advanced solid tumors.

Researchers are evaluating the safety, tolerability, anti-tumor effects, and pharmacokinetics of LVIVO-TaVec200 in adults with relapsed or refractory multiple myeloma who have not responded to at least three prior standard treatments. This open-label, single-arm, dose-escalation and dose-expansion study aims to better understand how this biological treatment behaves in the body and its potential impact on this condition. Participants will receive the LVIVO-TaVec200 product infusion after any necessary bridging therapy. The study includes a core period lasting about two years, covering screening, treatment, and follow-up phases. The dose of LVIVO-TaVec200 will be evaluated and adjusted during the first 30 days after infusion to determine the recommended Phase II dose. During the study, researchers will monitor the occurrence and severity of treatment-emergent adverse events as well as the pharmacokinetics of LVIVO-TaVec200 in both peripheral blood and bone marrow over approximately two years. Participants will undergo clinical laboratory tests and assessments of measurable lesions, with ongoing follow-up to track safety and treatment effects throughout the study period.

Researchers are evaluating the efficacy and safety of a new antibody-coupled drug called TQB2102 for injection in patients with unresectable locally advanced, recurrent, or metastatic HER2-positive gastroesophageal adenocarcinoma. This Phase II study focuses on how TQB2102 works in combination with Benmelstobart Injection or Penpulimab Injection, with or without chemotherapy, to target HER2 proteins on tumor cells and potentially improve treatment outcomes. The study aims to assess the Objective Response Rate (ORR) over about one year of participation. The treatments being studied include TQB2102 combined with Benmelstobart and chemotherapy or TQB2102 combined with Penpulimab and chemotherapy. TQB2102 is designed to bind more effectively to tumor cell HER2 proteins, while Benmelstobart and Penpulimab are antibodies that may help the immune system target cancer cells. Different dosing regimens of TQB2102 (6 mg or 7.5 mg) are being evaluated, and chemotherapy may be included depending on the treatment group. Participants will be monitored through regular evaluations during the study, which lasts approximately one year. Researchers will measure tumor response and safety outcomes, including lab tests and imaging to confirm measurable lesions according to RECIST 1.1 criteria. The study also involves reviewing previous PD-L1 expression test results or collecting tumor tissue for testing. Safety is closely observed, and participants must meet specific health criteria to join and continue in the trial.

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the efficacy and safety of TQH2929 injection in patients experiencing acute flare-ups of generalized pustular psoriasis (GPP). The study aims to provide evidence on how well TQH2929, a humanized monoclonal antibody, works in managing this severe skin condition. A total of 36 patients will participate in the trial. Participants will receive either TQH2929 injections or a placebo, with the placebo containing no active substance. The treatment is administered through injection, and all subjects will use either the study drug or placebo during the trial period. This setup allows researchers to compare outcomes between the two groups under controlled conditions. During the study, participants will be closely monitored through visits and procedures to assess treatment effects and safety. Researchers will measure outcomes such as the percentage of patients achieving a pustule score of zero after one week of treatment. Female participants of childbearing age must agree to use contraception during the study and for six months afterward. The trial will also include safety monitoring for infections, immune status, and other health factors over the course of participation.

Researchers are evaluating the effectiveness and safety of TQB6411 for Injection in adults with advanced lung cancer. This clinical trial is designed as a Phase Ib/II study to determine the recommended Phase II dosage and to observe the objective response rate over a period of up to six months. Participants must have confirmed lung cancer with measurable lesions and meet specific health and laboratory criteria to be eligible. The treatment involves administering TQB6411 for Injection every 21 days as a cycle. The study focuses on monitoring the drug’s safety and how well it works in treating advanced lung cancer. Participants will receive this treatment while being closely observed for any side effects or responses to the therapy. During the study, participants will undergo various assessments including laboratory tests, tumor tissue sampling for immunohistochemical testing, and regular health evaluations. The main outcomes measured are the recommended dosage for Phase II and the cancer's response to treatment over six months. Participants will be monitored for safety and treatment effects throughout the study period, which includes initial treatment and follow-up assessments.

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 studying the gut microbiome in people with several serious chronic diseases in China, including various cancers, hypertension, epilepsy, and kidney disease. The study aims to better understand the differences and similarities in gut microbiome patterns linked to these diseases and different regions, and how these patterns affect microbiome-based diagnostic tests. This work is important because past research has shown links between microbial imbalances and disease, but variability between studies has made it hard to draw clear conclusions. This observational study will recruit 500 patients diagnosed with each target disease and 500 healthy control participants matched by age and sex. Researchers will collect detailed information about participants' demographics, lifestyle, diet, medications, and health status. Biological samples including feces, saliva, urine, and blood will be collected for analysis. There is no active treatment or intervention; the study focuses on characterizing the microbiome and related health data. Participants will undergo assessments of their medical history and lifestyle, with sample collections to analyze microbiome and biochemical markers. Researchers will measure the baseline microbiome to identify disease-associated signatures. The study requires participants to be aged 18 to 75 and to have lived in the hospital's province for at least three years. Safety monitoring is observational, with no study treatments given. The total participant involvement includes data and sample collection for cross-sectional analysis.

Researchers are evaluating the safety and tolerability of DB-1311/BNT324 in adults with advanced or metastatic solid tumors in this Phase 1/2a trial. The study includes a dose-escalation phase to find the maximum tolerated dose and recommended Phase 2 dose, followed by a dose-expansion phase to confirm safety and explore effectiveness, including in prostate cancer patients receiving novel hormone therapy. Additionally, a sub-study will assess the effects of other drugs on DB-1311's behavior in the body. During Phase 1, participants receive increasing doses of DB-1311 administered intravenously using an accelerated titration and classic 3+3 design to determine safe dosage levels. Phase 2a expands on this to further evaluate safety and tolerability, with DB-1311 given alone or combined with hormone therapy drugs such as enzalutamide or abiraterone for prostate cancer. The study also investigates drug interactions with lopinavir/ritonavir and itraconazole. Treatment schedules and dosing details follow the study protocol at multiple centers. Participants will undergo various assessments including safety labs, vital signs, electrocardiograms, heart function tests, and performance status evaluations up to approximately one year after treatment. Researchers will monitor treatment-related toxicities, serious adverse events, and response rates. The involvement includes tumor biopsies for biomarker analysis and adherence to follow-up visits. The total study duration varies by phase, with ongoing safety and efficacy monitoring throughout.

Researchers are evaluating the anti-tumor effects of golidocitinib compared to treatments chosen by doctors in adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL). This phase 3, open-label, randomized, multinational study focuses on patients who have confirmed PTCL and whose disease has returned or not responded after at least one prior systemic treatment. The study includes specific subtypes of PTCL as defined by the World Health Organization classification. Participants will receive either golidocitinib at 150 mg orally once daily in 21-day cycles or one of several investigator's choice treatments, including chidamide, pralatrexate, gemcitabine, or belinostat, each given on different schedules and doses. Golidocitinib is taken daily with or without food, while the comparator drugs are administered orally or intravenously with specific timing within 21- or 28-day cycles. During the study, participants will be monitored for progression-free survival, which is the time from randomization until disease progression or death, assessed for up to approximately four years. Researchers will evaluate treatment effects through regular assessments, including clinical exams and safety monitoring. Patients must meet specific health criteria and agree to follow contraceptive guidelines throughout the trial.