Taizhou

Researchers are conducting a large-scale, multicenter, prospective cohort study to better understand ischemic stroke. The study focuses on identifying biological markers linked to this condition by collecting various samples such as blood, feces, and urine. Combining these biomarker data with demographic details, clinical signs, and imaging results, the study aims to create models for risk assessment, early detection, and prognosis prediction. Additionally, key genes and signaling pathways related to ischemic stroke will be explored. Participants who have had an ischemic stroke may receive treatments including intravenous thrombolysis with alteplase within the stroke onset time window. The study gathers detailed information to support its goals by integrating clinical and biological data from enrolled patients across multiple centers. During the study, participants will be monitored for cerebrovascular events and evaluated using modified Rankin Scale (mRS) scores at three months after stroke onset. Researchers will collect samples and clinical data to assess outcomes and develop predictive models. The study involves informed consent and follow-up to track patient progress and gather comprehensive information over time.

Researchers are investigating BNT3212, alone and combined with pumitamig (BNT327), in adults with advanced solid tumors who have no remaining standard treatment options. This first-in-human, open-label study aims to assess the safety, tolerability, pharmacokinetics, immunogenicity, and early signs of effectiveness of these treatments. The study includes multiple phases to carefully explore dosing and potential benefits while monitoring participant safety. The study is divided into four parts: Part A tests increasing doses of BNT3212 alone, Part B expands these doses in specific tumor types, Part C tests dose escalation of BNT3212 combined with pumitamig, and Part D expands this combination in select patient groups. Treatments are given by intravenous infusion, with doses adjusted or expanded based on ongoing safety and efficacy data. This stepwise approach helps identify the recommended doses for future studies. Participants will be closely monitored throughout the study period, which may last up to around 31 months, including follow-up after the last dose. Researchers will track side effects, treatment interruptions, and responses to therapy. Assessments include imaging for tumor measurements, laboratory tests for organ function, immune response evaluations, and overall health status. Safety observations continue up to 90 days post-treatment to ensure participant well-being.

Researchers are evaluating the effectiveness and safety of sunvozertinib compared to a placebo as additional treatment after surgery in patients with early-stage non-small cell lung cancer (NSCLC) that have specific mutations in the EGFR gene, including exon 20 insertion mutations and PACC mutations. This phase 3, double-blind, randomized study includes patients who have undergone complete tumor removal and aims to assess disease-free survival up to approximately five years after treatment begins. Participants are randomly assigned to receive either oral sunvozertinib 200 mg once daily or a matching placebo, with each treatment cycle lasting 21 days. Treatment continues until disease recurrence, intolerable side effects, completion of a three-year treatment period, study end, death, or withdrawal by the participant. The study allows patients who received prior adjuvant chemotherapy or those who did not, with specific timing guidelines for randomization after surgery and chemotherapy. During the study, participants will be monitored regularly through assessments by investigators to determine disease-free survival, safety, and tolerability. Participants must provide tumor tissue samples for mutation confirmation and undergo evaluations of organ function and physical status before starting treatment. The total duration of treatment can last up to three years, with ongoing safety and disease status monitoring extending up to about five years after enrollment.

Researchers are investigating the similarity in pharmacokinetic (PK) profile, effectiveness, safety, and immune response of HLX17 compared to US-sourced Keytruda® in patients who have had surgery for non-small cell lung cancer, melanoma, or renal cell carcinoma. This Phase I, multicenter, randomized, double-blind study aims to compare these two treatments in people with these resected solid tumors to better understand their performance and safety profiles. Participants will receive either HLX17 or US-sourced Keytruda®, each given at a dose of 200 mg on the first day of every 3-week cycle. The study is designed with parallel groups, where each participant receives one of the treatments across multiple cycles. The dosing schedule continues through six cycles, and the two treatments are directly compared under controlled conditions. Throughout the study, participants will be monitored closely with various assessments including laboratory tests and evaluations of organ function to ensure safety. The main outcomes measured are drug exposure over time from the first dose to 21 days after the initial and sixth doses. Participants are expected to have a performance status of 0 and a life expectancy of at least 12 weeks. Safety and immunogenicity will also be evaluated, with follow-up to monitor any side effects or immune responses during and after treatment.

Researchers are evaluating the safety and early effectiveness of AL8326 tablets combined with Toripalimab in patients with advanced recurrent or metastatic solid tumors. This open, non-randomized Phase I/IIa clinical trial focuses on patients who have failed standard therapies or for whom no effective treatment is available, including those receiving Toripalimab as a second-line or later treatment. The study aims to determine the recommended dose and assess tumor response over time. Participants will receive AL8326 tablets orally once daily at a dose of 10 mg per tablet, alongside Toripalimab administered by injection every 21 days at 240 mg per cycle. The trial includes a Phase I portion to identify the recommended dose after the first 28-day cycle, followed by a Phase IIa segment that monitors objective remission rates every 2 to 4 cycles, continuing for up to 24 months. Treatment schedules and dosages are carefully managed to evaluate combined therapy effects. During the study, participants will undergo regular medical assessments, including tumor measurements using RECIST 1.1 criteria and safety evaluations such as blood tests, heart function tests, and monitoring of side effects. Researchers will track the participants' response to treatment, life expectancy, organ function, and overall health status. Follow-up procedures ensure safety and effectiveness are continually monitored throughout the treatment period and beyond.

Researchers are investigating the appropriate dosage, safety, tolerability, and effectiveness of HLX43, an anti-PD-L1 antibody linked to a potent DNA topoisomerase I inhibitor, combined with Serplulimab, an anti-PD-1 humanized monoclonal antibody, in adults with advanced or metastatic solid tumors, including non-small cell lung cancer with specific genetic mutations. This open-label phase Ib/II clinical trial includes patients who have failed previous treatments or have no standard therapy options. The study is separated into a phase Ib dose escalation and a phase II dose expansion to assess these treatments. Participants will receive varying doses of HLX43 combined with a fixed 300 mg dose of Serplulimab administered through intravenous infusion every three weeks. The treatment continues as per the study protocol, with dose levels adjusted during the phase Ib portion to determine the maximum tolerated dose. The phase II expansion evaluates the selected dosage in a larger group. HLX43 is designed with a drug-antibody ratio of eight to optimize its treatment effect. Throughout the study, participants undergo evaluations including measurement of tumor lesions by RECIST 1.1 criteria, PD-L1 expression testing from tumor samples, and assessments of organ function and performance status. Researchers monitor dose-limiting toxicities within 21 days after the first dose, overall response rate up to 24 weeks, and maximum tolerated dose during the approximately 12-month study duration. Safety and tolerability are closely followed, along with survival predictions and adverse event monitoring, to understand how well participants tolerate the combination therapy and its impact on tumor response.

Researchers are evaluating the safety, effectiveness, and how the body processes YL201 in men with metastatic castration-resistant prostate cancer (mCRPC) in this multicenter, open-label Phase II study conducted in China. The study focuses on patients with advanced prostate cancer that continues to progress despite hormone therapy, aiming to better understand YL201's potential in this condition. Participants will receive YL201 through intravenous infusion either once every three weeks on Day 1 or twice every three weeks on Day 1 and Day 8 within each 21-day cycle. This treatment schedule will continue as per the study protocol. The research aims to determine the best dose of YL201 for future studies and monitor how the drug behaves in the body over approximately three years. During the study, patients will be closely monitored through imaging scans and clinical evaluations to assess tumor response and progression-free survival based on established cancer response criteria. Researchers will also evaluate safety and drug levels in the body. Patients will be followed for about 36 months to collect comprehensive data on treatment effects, side effects, and overall outcomes.

Researchers are evaluating the effectiveness and safety of combining RC108 with Furmonertinib compared to using Furmonertinib alone for first-line treatment in adults aged 18 to 75 years with EGFR-mutated, MET-positive, unresectable locally advanced or recurrent metastatic non-small cell lung cancer (NSCLC). This Phase II trial aims to provide new options for patients whose cancer cannot be removed by surgery or treated with radiation. The study also looks at how the body processes RC108 and whether the immune system reacts to it when given with Furmonertinib. Participants will be randomly assigned to receive either the combination of RC108 and Furmonertinib or Furmonertinib alone. Treatments are taken as medications, and the study monitors patients over time to compare their responses. The study includes patients who have not received previous systemic therapy for their advanced or recurrent disease. Tumor tissue samples are collected for testing, and participants must have measurable cancer lesions. During the study, participants will undergo regular assessments including physical exams, performance status evaluation, and tumor measurements according to RECIST criteria. Researchers will track the objective response rate over 24 months to determine how well the treatments work. Safety will be closely monitored along with patient survival and overall health. Participants are expected to use effective contraception if of childbearing potential and will be followed for treatment effects and side effects throughout the study period.

Researchers are conducting a prospective, multi-center, non-interventional cohort study across China to investigate Drug-induced Liver Injury (DILI). The study aims to explore the clinical characteristics, responsible drugs or herbs, patient outcomes, and risk factors associated with DILI. An important goal is to identify new serum markers that could help predict the prognosis of this condition. The study also seeks to develop and validate a prognostic model incorporating these novel serum markers to improve patient care in China. Participants will be followed in a nationwide standardized cohort with long-term monitoring to collect detailed prognostic data on DILI. The study does not involve experimental treatments but focuses on observation and data collection to help understand DILI better. No specific interventions are delivered as part of this research. During the study, participants will undergo evaluations to confirm diagnosis and monitor their liver health over time. Researchers will measure primary outcomes including death or liver transplantation within one year and the occurrence of acute liver failure within one year. The study involves ongoing assessments to gather clinical data and validate the prognostic model based on novel serum biomarkers, aiming to enhance future management of DILI.

Researchers are evaluating the effectiveness and safety of two treatment combinations for elderly patients newly diagnosed with multiple myeloma who are not planning to undergo stem cell transplant initially. The study compares daratumumab, lenalidomide, and dexamethasone (DRd) with a modified regimen of bortezomib, lenalidomide, and dexamethasone (VRd-lite). The main goals are to measure how long patients survive without disease progression and the rate of minimal residual disease negativity. Participants can choose between the two treatment options. Daratumumab is given intravenously weekly for the first 8 weeks, then every two weeks for 16 weeks, and finally every 4 weeks in later cycles. Bortezomib is administered by injection once a week during each 28-day cycle for 8 cycles. Both groups receive lenalidomide orally for 21 days of each cycle and dexamethasone twice a week. After initial treatment, all participants continue lenalidomide maintenance until the disease worsens or side effects become unacceptable. During the study, participants undergo regular evaluations including tests for disease progression and minimal residual disease status at various time points up to approximately 5 to 8 years. Safety is monitored throughout. The study involves ongoing assessments such as laboratory tests and clinical evaluations to track treatment response, side effects, and overall health during and after therapy.