Clinical trials

Chronic migraine is a disabling neurological disorder characterized by frequent headache attacks and significant impairment of quality of life. Low-intensity focused ultrasound (LIFUS) is a non-invasive neuromodulation technique that can precisely target deep brain regions. This study aims to evaluate the efficacy, safety, and tolerability of LIFUS targeting the left dorsolateral prefrontal cortex (DLPFC) for preventive treatment of chronic migraine in adults. This is a randomized, single-blind, sham-controlled clinical trial. Eligible participants with chronic migraine will be randomly assigned to receive either active LIFUS stimulation targeting the left DLPFC or sham stimulation. Participants will receive 10 stimulation sessions over 2 weeks and will be followed for 3 months after intervention. The primary outcome is the change in monthly migraine days from baseline to 1 month after intervention. Secondary and exploratory outcomes include headache-related disability, quality of life, psychological assessments, electrophysiological measurements, neuroimaging changes, and safety outcomes.

The study is to observe safety, survival effect and peripheral T-lymphocyte subsets of combination therapy with percutaneous microwave ablation (MWA) and adoptive immunotherapy in hepatocellular carcinoma(HCC).

KSVCBD injection is an in vivo Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This multicenter, single-arm, open-label, early exploratory clinical study is designed to evaluate the preliminary safety and efficacy of KSVCBD injection in patients with relapsed or refractory (r/r) multiple myeloma(MM) expressing CD19 and/or BCMA.

Ceftobiprole, a fifth-generation cephalosporin, exhibits potent antibacterial activity against MRSA, penicillin-resistant Streptococcus pneumoniae (PRSP), and certain Gram-negative bacteria (e.g., Pseudomonas aeruginosa). In elderly patients, significant interindividual variability often leads to inappropriate dosing (subtherapeutic or excessive), compromising efficacy or increasing toxicity risks. This prospective, multicenter study will enroll patients aged ≥60 years receiving ceftobiprole. Using LC-MS/MS for therapeutic drug monitoring (TDM), we will measure plasma concentrations and integrate individual characteristics (age, body weight, creatinine clearance, etc.). Population pharmacokinetic (PPK) modeling with Bayesian forecasting will be employed to estimate individual PK parameters and identify covariates influencing variability, thereby establishing a PPK model for ceftobiprole in the elderly. Based on pathogen-specific MIC values, dosing regimens (dose, frequency) will be dynamically optimized to guide precision therapy. Subsequent TDM data will continuously refine the PPK model, creating a self-optimizing system. This framework lays the groundwork for extending individualized treatment strategies to other antimicrobials in geriatric populations.

Epithelial ovarian cancer is the most lethal gynecologic malignancy, and most patients eventually relapse and develop resistance to available therapies. Immune checkpoint inhibitors have shown limited overall efficacy in recurrent ovarian cancer, partly because of its immunosuppressive tumor microenvironment. Manganese (Mn2+) can activate the cGAS-STING pathway and may enhance antitumor immunity and the therapeutic effects of PD-1 blockade combined with chemotherapy. Following encouraging findings from an early-phase study, a randomized, single-blind, placebo-controlled phase II trial showed that the addition of manganese chloride to anti-PD-1 antibody, nab-paclitaxel, and cisplatin improved clinical outcomes compared with placebo, with an overall manageable safety profile. Based on these findings, this phase III trial is designed to confirm the efficacy and further evaluate the safety of Mn2+-primed immunochemotherapy in patients with advanced ovarian cancer.

This study is an open-label, single-arm, exploratory study designed to evaluate the efficacy and safety of Obinutuzumab beta combined with a rapid-tapering glucocorticoid regimen in patients with new-onset ANCA-associated glomerulonephritis (AAGN).

This is a single center, prospective, open-label, single-arm, phase 1/2 study for patients with r/r B-cell NHL to evaluate the safety and efficacy of gene edited allogenic CD19 CAR-γδT cells. The cells are from healthy adult volunteer donors that are gene edited ex vivo using CRISPR-Cas9 to weaken HLA expression and further to overcome host immune system rejection (HvGR). In this study, a second generation anti-CD19 CAR prototype was constructed, bearing murine FMC63 single-chain variant fragment (scFv) together with intracellular 4-1BB co-stimulatory and CD3ζ signaling domains linked by a CD8α sequence comprising the hinge and transmembrane domains. This upgraded version of the CAR-γδT product will be used in this study after March 20th, 2024. A total of around 30 patients with r/r B-cell NHL will be enrolled in the study and receive allogeneic CD19 CAR-γδT cell infusion. Phase 1 (n=9 to 12) is dose escalation part, and phase 2 (n=15 to 20) is expansion cohort part. The primary objective of this study was to evaluate the safety and efficacy of allogeneic CD19 CAR-γδT cell therapy in patients with r/r B-cell NHL.

Acute kidney injury (AKI) is a common complication after major liver surgery. This study will evaluate whether intraoperative management guided by renal regional oxygen saturation (RrSO₂), measured using near-infrared spectroscopy, can reduce postoperative acute kidney injury in adults undergoing elective hepatectomy. Approximately 1,200 participants at about 20 hospitals in China will be randomly assigned in a 1:1 ratio to RrSO₂-guided management or usual perioperative care. All participants will undergo continuous bilateral renal RrSO₂ monitoring. In the intervention group, RrSO₂ values will be visible to the anesthesia team, and a decrease of 10% or more from baseline on either side will trigger a standardized assessment and stepwise management algorithm. In the control group, RrSO₂ data will be recorded but concealed from the clinical team and will not guide treatment. The primary outcome is AKI within 7 days after surgery or before hospital discharge, whichever occurs first, based on Kidney Disease: Improving Global Outcomes serum creatinine criteria or initiation of renal replacement therapy.

Background:Lipomas are the most common benign soft tissue tumors, traditionally treated by open surgical excision. However, open surgery is associated with relatively large incisions, prolonged recovery, and visible scarring. While liposuction offers a less invasive alternative, it often achieves unsatisfactory clearance rates for lipomas with significant fibrotic components, leading to higher recurrence rates. Study Objective:This study aims to investigate the safety and efficacy of CUSA in the minimally invasive treatment of lipomas. Study Methods:this is a single-center, prospective clinical study. A total of 30 eligible patients with clinically diagnosed lipomas scheduled for surgical treatment will be enrolled. All participants will undergo minimally invasive tumor resection using the CUSA system. The primary outcome measure is tumor clearance rate .Secondary outcome measures include operation time, intraoperative blood loss, postoperative pain score, complication rate, recurrence rate, cosmetic outcome, and patient satisfaction. Patients will be followed up for 6 months after treatment. Study Significance:The results of this study will provide evidence-based clinical support for the application of CUSA in the minimally invasive treatment of lipomas, particularly for lesions with abundant fibrotic components, and may help optimize treatment strategies and improve patient outcomes.

Background： Benign breast nodules are common breast diseases in women, including fibroadenomas, hyperplastic nodules, and other benign lesions. Traditionally, open surgical excision has been the standard treatment, but it is associated with visible scarring, damage to breast shape, prolonged recovery, and high costs. While minimally invasive approaches such as vacuum-assisted excision and thermal ablation (radiofrequency, microwave, laser) have been developed, they still have limitations including intraoperative bleeding, residual lesions, skin injury, and postoperative pain. Ultrasound-guided emulsification therapy is an emerging minimally invasive technique that utilizes ultrasonic energy to emulsify nodule tissue followed by aspiration, offering potential advantages of precise tissue targeting, minimal damage to surrounding normal breast tissue, favorable cosmetic outcomes, and rapid recovery. However, its clinical safety and efficacy in the treatment of benign breast nodules remain to be systematically evaluated. Study Objective： This study aims to investigate the safety and efficacy of ultrasound-guided emulsification therapy in the minimally invasive treatment of benign breast nodules. Study Methods： This is a single-center, prospective clinical study. A total of 30 eligible patients with clinically and pathologically confirmed benign breast nodules scheduled for treatment will be enrolled. All participants will undergo ultrasound-guided emulsification therapy. The primary outcome measure is the nodule clearance rate (complete disappearance rate assessed by postoperative ultrasound). Secondary outcome measures include operation time, intraoperative blood loss, postoperative pain score (VAS), complication rate, recurrence rate at follow-up, cosmetic outcome assessment, and patient satisfaction. Patients will be followed up for 6 months after treatment. Study Significance： The results of this study will provide evidence-based clinical support for the application of ultrasound-guided emulsification therapy in the minimally invasive treatment of benign breast nodules, and may help optimize treatment strategies, preserve breast shape and aesthetics, and improve patient outcomes and quality of life.

To evaluate the safety and efficacy of a population pharmacokinetics (PK)-guided targeted ATG dosing strategy in haploidentical stem cell transplantation and to observe the GVHD-free, relapse-free survival (GRFS) in the cohort receiving this strategy.

This prospective observational study aims to compare photon-counting detector computed tomography angiography (PCD-CTA) with conventional energy-integrating detector computed tomography angiography (EID-CTA) for the assessment of carotid atherosclerotic plaques in patients with carotid artery stenosis.

This study is a multicenter, prospective, randomized, controlled clinical trial, observing the efficacy and safety of the CACAG+Venetoclax regimen (Chidamide + Azacitidine + Aclarubicin + Cytarabine + Recombinant Human Granulocyte Colony-Stimulating Factor + Venetoclax) in elderly patients with newly diagnosed Acute Myeloid Leukemia (AML). The control group applies the standard "3+7" regimen. The aim is to improve the remission rate of AML patients, reduce the probability of adverse events, and thereby improve patient prognosis and extend patient survival.

Background: Age-related macular degeneration (AMD) is a common eye disease that can cause blindness in older adults. The "wet" form of AMD, called neovascular AMD, happens when abnormal blood vessels grow under the retina and leak fluid. The current standard treatment requires repeated eye injections of anti-VEGF drugs, often every month or every few months. This frequent injection schedule is a heavy burden for patients and many cannot keep up with the treatment plan. Purpose: This study tests whether a single session of low-intensity laser applied to the diseased area, given just before the anti-VEGF injection, can help the drug reach the target more effectively. If this works, patients may need far fewer injections over time. Intervention: Participants will be randomly assigned to one of two groups. The experimental group will receive the laser treatment followed by an anti-VEGF injection within 6 hours. The control group will receive the anti-VEGF injection alone, according to the current standard regimen. Four different anti-VEGF drugs are allowed in this study: conbercept, aflibercept, ranibizumab, and faricimab. Participants: The study plans to enroll at least 240 patients with active neovascular AMD across five hospitals in China. All participants must be at least 50 years old and meet specific eligibility criteria. Follow-up: All participants will be followed for 24 months with monthly clinic visits. The study will record the total number of injections received, changes in vision, fluid status on eye scans, and any side effects. Primary Outcome: The main measure is the total number of anti-VEGF injections each participant needs over the 24-month period. The study will compare the experimental group and the control group to see whether the laser-enhanced approach reduces the injection frequency.

This Phase 1, open-label, single-arm, dose-escalation study is designed to evaluate the safety and tolerability of SL1617 Injection in patients with relapsed or refractory B-cell lymphoma. SL1617 is an investigational in vivo CAR T-cell immunotherapy targeting CD19 and CD20, utilizing an engineered lentiviral vector to generate functional CAR-T cells in vivo without the need for ex vivo cell processing or lymphodepletion. Participants will receive a single intravenous infusion of SL1617 using a traditional 3+3 dose-escalation design. The planned starting dose is 1.0 × 10\^9 transducing units (TU), followed by dose levels of 3.0 × 10\^9 TU and 6.0 × 10\^9 TU. Dose escalation will be guided by the occurrence of dose-limiting toxicities (DLTs).

This multicenter prospective observational cohort study aims to investigate the association between cumulative cold-region exposure and adverse left ventricular remodeling and cardiovascular outcomes in patients with coronary artery disease undergoing successful percutaneous coronary intervention (PCI). Individual-level chronic cold exposure will be quantified primarily by cumulative months of residence, work, or other relevant exposure in cold regions during the 3 years preceding PCI. Additional exposure measures will include regional cold-wave days derived from meteorological records and winter outdoor occupational exposure. Participants will undergo baseline cardiovascular magnetic resonance (CMR), echocardiography, electrocardiography, and clinical and laboratory assessment after PCI. Echocardiography will be repeated at 6 months to assess left ventricular remodeling. Cardiovascular events will be prospectively collected during follow-up. The study will evaluate whether cumulative cold-region exposure is associated with distinct CMR phenotypes, adverse left ventricular remodeling, and major adverse cardiovascular events (MACE), and whether cold-exposure measures provide incremental prognostic information beyond conventional clinical, imaging, and electrocardiographic risk markers.

This study takes patients who have undergone percutaneous coronary intervention as the research subjects and employs a prospective observational cohort design, aiming to develop and validate a "one-stop" photon-counting computed tomography imaging framework. The one-stop PCCT protocol implies that multiple assessments are acquired through a single examination, including coronary CT angiography for stent and native artery evaluation, resting first-pass myocardial iodine distribution imaging, and delayed myocardial extracellular volume quantification, with cardiac cine imaging performed in a prespecified dose-controlled substudy.

Objective of the Clinical Trial The objective of this clinical trial is to preliminarily assess the feasibility and safety of performing precise prostate thermal vapor ablation under MRI/TURS guidance. The primary questions it aims to address are: Can precise prostate thermal vapor ablation under MRI/TURS guidance effectively treat benign prostatic hyperplasia (BPH) and alleviate lower urinary tract symptoms (LUTS)? What safety issues may arise in participants after undergoing prostate thermal vapor ablation? Study Procedures Participants Preoperative Evaluation: Participants will undergo comprehensive preoperative assessments, including clinical examinations and laboratory tests. Procedure: Participants will receive precise prostate thermal vapor ablation under MRI/TURS guidance. Postoperative Follow-up: Regular follow-up to reassess prostate volume. Periodic completion of the International Prostate Symptom Score (IPSS) questionnaire. Regular measurement of maximum urinary flow rate (Qmax) and post-void residual urine volume (PVR). Research Team The research team will conduct precise prostate thermal vapor ablation under MRI/TURS guidance for the participants and manage their follow-up assessments.

This study is a retrospective analysis of a large-scale multicentre prospective cohort study that investigates the impact of preoperative depression on the incidence of postoperative delirium among elderly Chinese patients undergoing non-cardiac major surgery.

A multicenter, cross-sectional study to characterize the clinical profiles of the Chinese elderly population and to determine the prevalence of preoperative anxiety and depression.

This study aims to validate the 2025 ASAS-SPARTAN revised classification criteria for axial spondyloarthritis (axSpA) in the Chinese population through a multicenter, prospective, cross-sectional observational study. Axial spondyloarthritis is a chronic inflammatory disease primarily affecting the spine and sacroiliac joints, causing back pain and stiffness. Early and accurate diagnosis is essential for timely treatment and improved patient outcomes. The 2025 ASAS-SPARTAN revised classification criteria were recently developed by the Assessment of SpondyloArthritis International Society (ASAS) and the SpondyloArthritis Research and Treatment Network (SPARTAN) to improve diagnostic accuracy and reduce over-diagnosis, with preset targets of sensitivity ≥75% and specificity ≥90%. However, the original validation study included only 71 Chinese patients out of 1,015 total participants, and racial differences in susceptibility genes, living environments, and socioeconomic-cultural backgrounds may affect the criteria's performance in Chinese patients. This study will enroll patients with chronic back pain (CBP) lasting ≥3 months and onset age ≤45 years from multiple hospitals in China. All participants will undergo comprehensive diagnostic assessments including clinical history, physical examination, CRP testing, HLA-B27 testing, pelvic X-ray, and sacroiliac joint MRI. The 2025 ASAS-SPARTAN criteria will be applied to evaluate diagnostic performance, and results will be compared with the 2009 ASAS classification criteria and clinicians' gold-standard diagnoses. The primary objective is to validate the sensitivity, specificity, and internal scoring rationality of the 2025 ASAS-SPARTAN criteria in Chinese axSpA patients. The secondary objective is to assess the concordance between the 2025 and 2009 ASAS criteria and analyze reasons for any discrepancies. The findings will provide evidence for Chinese clinicians to select appropriate classification tools, reduce over-diagnosis of axSpA, and alleviate the burden on the healthcare system.

This multicenter retrospective and prospective real-world observational study will evaluate the relationship of Helicobacter pylori (H. pylori) infection status, intragastric distribution, and pathological features with gastric cancer biological behavior and long-term prognosis in patients with early gastric cancer or related gastric neoplastic lesions undergoing endoscopic submucosal dissection (ESD). H. pylori infection is an important risk factor for gastric cancer. In clinical practice, H. pylori status can be assessed by several methods, including the 13C-urea breath test, serum H. pylori antibody testing, and pathological assessment of gastric tissue. These methods may not always provide the same result because they reflect different aspects of infection, including current active infection, previous exposure, prior eradication status, and local tissue-based detection. The study will include approximately 1500 participants from participating medical centers. About 1000 participants will be retrospectively identified from existing clinical, endoscopic, pathological, H. pylori testing, and follow-up records, and about 500 additional participants will be prospectively enrolled. The study will evaluate H. pylori infection status, prior eradication status, discordant testing patterns, tissue-based and intragastric H. pylori distribution, background mucosal changes, and pathological features of early gastric cancer or related gastric neoplastic lesions. These features will be analyzed in relation to different gastric cancer subtypes and biological behavior. Follow-up information will be used to evaluate whether the integrated analysis of H. pylori infection status and pathological features can predict clinical outcomes at 1, 2, and 3 years after ESD and during long-term follow-up, including local recurrence, metachronous gastric cancer, synchronous or multifocal early gastric cancer detected within 1 year, additional surgical treatment, survival, and other clinically meaningful outcomes.

Immunoglobulin G4-related disease (IgG4-RD) is a chronic immune-mediated disorder characterized by inflammation, fibrosis, and involvement of multiple organs. Although glucocorticoids can effectively induce remission, many patients experience disease relapse after glucocorticoid tapering or discontinuation, and long-term glucocorticoid exposure may cause significant adverse effects. Therefore, new maintenance treatment strategies are needed to reduce relapse risk and minimize glucocorticoid-related toxicity. This study is designed to evaluate the efficacy and safety of lenalidomide as a maintenance therapy in patients with stable IgG4-RD. This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial. Eligible participants will be adults with IgG4-RD who meet the 2019 ACR/EULAR IgG4-RD classification criteria and are in a stable disease state. Participants will be randomly assigned in a 1:1 ratio to receive either lenalidomide or matching placebo for 52 weeks. All participants will receive standardized glucocorticoid tapering according to the study protocol. The primary objective of this study is to determine whether lenalidomide can reduce the risk of IgG4-RD relapse compared with placebo. The primary outcome is the proportion of participants experiencing disease relapse within 52 weeks after randomization. Secondary objectives include evaluation of time to relapse, maintenance of remission, changes in disease activity, quality of life, and safety outcomes. Exploratory assessments will investigate changes in immunological biomarkers, peripheral blood immune profiles, transcriptomic characteristics, and gut microbiota. This study aims to provide clinical evidence for a new maintenance treatment approach for patients with IgG4-RD and potentially reduce disease recurrence and glucocorticoid exposure.

This study will evaluate the safety and effectiveness of different surgical treatments for men with small-volume benign prostatic hyperplasia (BPH). Men with small-volume BPH may still have bothersome lower urinary tract symptoms and bladder outlet obstruction, and the best surgical treatment for this group remains uncertain. In this multicentre, randomized, single-blind, four-arm controlled trial, 932 eligible men aged 40 to 80 years will be assigned in a 1:1:1:1 ratio to one of four groups: thulium laser enucleation of the prostate combined with bladder neck incision, thulium laser enucleation of the prostate alone, transurethral resection of the prostate (TURP), or transurethral incision of the prostate (TUIP). The main goal of the study is to compare the incidence of bladder neck contracture at 6 months after surgery. Secondary outcomes include safety outcomes and changes in urinary symptoms, urinary flow rate, pain score, and symptom response at 3 and 6 months after surgery. Exploratory outcomes include changes in post-void residual urine volume and sexual function scores. Additional exploratory long-term outcomes will also be assessed at 12 months after surgery.

KSVCBD injection is an in vivo Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This multicenter, single-arm, open-label, early exploratory clinical study is designed to evaluate the preliminary safety and efficacy of KSVCBD injection in patients with relapsed or refractory (r/r) B-cell non-Hodgkin's lymphoma (NHL) CD19 and/or BCMA.