Clinical trials

This is a prospective, single-center phase I/II study, with the purpose of evaluating the efficiency of golidocitinib combined with chidamide in patients with systemically-treated cutaneous T-cell lymphoma. The primary endpoint of the phase I study was to determine the recommended phase II dose (RP2D), while the primary endpoint of the phase II study was the objective response rate (ORR). Secondary endpoints included the complete response (CR) rate, progression-free survival (PFS), duration of response (DOR), overall survival (OS), and safety profile.

Branch atheromatous disease (BAD) is a distinct subtype of ischemic stroke that is particularly prevalent among Chinese and other Asian populations. Patients with BAD are prone to early neurological deterioration and poor functional outcomes, and BAD is increasingly recognized as an independent disease entity. However, the association between BAD and cognitive impairment remains unclear. This nationwide, multicenter, prospective observational study will prospectively collect epidemiological, clinical, neuroimaging, functional, and cognitive outcome data from patients with BAD. The study aims to investigate the occurrence of cognitive impairment after BAD and identify the clinical and neuroimaging characteristics associated with cognitive impairment. In particular, the relationship between early neurological deterioration (END) and cognitive impairment will be investigated. As an exploratory objective, this study will further explore the potential brain network mechanisms underlying cognitive impairment associated with END events.

This study aims to investigate the feasibility of utilizing the SurgDiff surgical difficulty prediction model to assist surgeons in formulating precise surgical plans.

This is a prospective single-arm phase II study, with the purpose of evaluating the efficiency of ZR-MTX regimen (Rituximab, Zanubrutinib and methotrexate) combined with intravitreal methotrexate, then followed by minimal residual disease directed Zanubrutinib maintenance in newly-diagnosed primary intraocular lymphoma. The primary endpoint of this study is progression-free survival (PFS).

A multicentre randomised controlled trial evaluating whether a rare-disease diagnostic large language model can improve diagnostic quality, efficiency, and health-economic outcomes for physicians managing patients with suspected rare or diagnostically unresolved disease.

This is a prospective, open-label, multicenter, single-arm Phase II study designed to evaluate the efficacy and safety of sacituzumab tirumotecan (sac-TMT/SKB264) in combination with tagitanlimab (KL-A167) as second-line or later therapy in patients with recurrent or metastatic MSI-H/dMMR gynecological malignancies, including endometrial cancer, ovarian cancer, and cervical cancer. The primary objective is to evaluate the objective response rate (ORR) per RECIST v1.1 as assessed by the investigator. Secondary objectives include evaluating overall survival (OS), progression-free survival (PFS) per RECIST v1.1, disease control rate (DCR), duration of response (DoR), and the safety and tolerability of the combination regimen.

This is a single-center prospective observational cohort study enrolling adult patients scheduled for cardiac surgery. Multi-timepoint clinical indicators, stool samples for gut microbiota and metabolomics profiling and artery blood will be collected before and after surgery. We aim to construct and validate a multi-dimensional preoperative predictive model for CSA-AKI based on clinical, microbial and metabolic signatures. Meanwhile, this research will explore the potential mediating role of the gut-kidney axis in the pathogenesis of cardiac surgery-associated acute kidney injury, and provide novel mechanistic evidence for early risk stratification and intervention of CSA-AKI.

Grounded in the 'disease-syndrome combination' paradigm, this study endeavors to address the pivotal scientific issues pertaining to the clinical precision of Traditional Chinese Medicine (TCM) in managing Diminished Ovarian Reserve (DOR) classified as the Kidney Essence Deficiency type, through the application of systems biology technologies, including metabolomics.

Primary Sjögren's syndrome (pSS) is a chronic autoimmune exocrinopathy characterized by lymphocytic infiltration, progressive destruction of salivary gland acini, and varying degrees of functional impairment and fibrosis. Conventional imaging provides limited ability to simultaneously evaluate glandular function and inflammatory activity, leading to challenges in disease staging and treatment decision-making. This study explores a conceptual dual-tracer imaging framework using PSMA PET and FAPI PET to delineate complementary biological processes in pSS.

The goal of this clinical trial is to learn whether adding the JAK inhibitor golidocitinib to standard corticosteroid therapy works to treat rapidly progressive interstitial lung disease (RP-ILD) in patients with acute worsening. It will also learn about its safety compared to standard treatment without JAK inhibitors (i.e., corticosteroids plus other immunosuppressants such as mycophenolate mofetil, tacrolimus, cyclophosphamide, or biologics). The main questions it aims to answer are: * How much does the addition of golidocitinib improve lung function, measured by the absolute change in FVC (mL), after 12 weeks of treatment? * How does it compare to standard therapy in terms of changes in FVC% predicted, oxygenation index, chest CT score, need for invasive respiratory support, all-cause mortality, relapse rate, and incidence of opportunistic infections? Researchers will compare the golidocitinib group (golidocitinib 150 mg once daily plus corticosteroids) to the control group (corticosteroids plus non-JAK inhibitor immunosuppressants). All patients receive high-dose corticosteroids (prednisone equivalent ≥1 mg/kg/day) with a tapering regimen. Participants will: * Receive either golidocitinib plus corticosteroids or control treatment for 12 weeks * Visit the clinic for check-ups, blood tests, and lung function tests at weeks 1, 2, 4, 6-8, and 12 * Have chest high-resolution CT scans at weeks 2, 4-6, and 12 to monitor disease progression * Be monitored for adverse events and efficacy outcomes throughout the 12-week period

The goal of this clinical trial is to learn whether short-term treatment with atorvastatin can prevent new abnormal rapid heart rhythms after lung surgery in adults aged 60 years or older who are scheduled to have a lung segment or lung lobe removed. The study will also evaluate the safety of short-term atorvastatin treatment around the time of surgery. The main questions this study aims to answer are: * Does perioperative atorvastatin lower the number of participants who develop atrial fibrillation or a related rapid rhythm from the upper chambers of the heart during the first 72 hours after surgery? * What medical problems or changes in liver, kidney, or muscle-related laboratory tests occur during treatment? Participants will be assigned by chance to receive either short-term atorvastatin treatment or a matching placebo-based comparison treatment. A placebo is a look-alike tablet that does not contain atorvastatin. Participants who were already taking a statin (moderate-intensity) before the study will receive a standardized background statin regimen so that their usual treatment is not stopped unnecessarily. Neither the participants nor most members of the research team will know which treatment has been assigned. Study treatment will usually begin 2 to 7 days before surgery and continue until 72 hours after surgery. After surgery, participants will wear a portable heart monitor continuously for 72 hours to identify abnormal heart rhythms. Researchers will also collect routine clinical information, blood test results, and safety information during the hospital stay and will follow participants for 30 days after surgery.

This is a very safe and beneficial clinical study. We hope to obtain near-real airway anatomical parameters of patients before surgery through airway three-dimensional reconstruction technology, to assist anesthesiologists in matching the most suitable double-lumen bronchial tube size for each patient, thereby reducing the rate of intubation failure and the occurrence of perioperative adverse events to a certain extent.

Childhood-onset systemic lupus erythematosus (cSLE) is a severe chronic autoimmune disease with a high burden of major-organ involvement. Lupus nephritis (LN) affects more than half of children with SLE, and proliferative LN-including class III, IV, III+V, and IV+V disease-is associated with acute kidney injury, progression to end-stage kidney disease, and poor long-term outcomes. Glucocorticoids remain a cornerstone of induction therapy for proliferative LN. However, the optimal initial dose in children is uncertain. Although recent adult SLE and LN guidelines increasingly recommend lower-dose glucocorticoid regimens with rapid tapering, pediatric guidelines still commonly recommend high initial prednisone doses of 1.5-2.0 mg/kg/day. Adult trials and comparative observational studies suggest that lower-dose glucocorticoid regimens may preserve efficacy while reducing treatment-related toxicity. Because cumulative glucocorticoid exposure in children may impair growth, development, psychosocial well-being, and medication adherence, this trial will compare low-dose versus high-dose initial glucocorticoid regimens for induction treatment of pediatric proliferative LN. The objective is to determine whether a lower-dose regimen is non-inferior in efficacy while reducing glucocorticoid-related adverse effects and improving quality of life.

An investigation into the survival outcomes, progression-free survival, and safety of triple therapy with Trastuzumab Rezetecan, Adebrelimab, and Lenvatinib in patients with advanced HER2-positive/low-expressing biliary tract cancer after the failure of at least two prior systemic therapies.

This study is a prospective, multicenter, double-blind, randomized, placebo-controlled clinical trial designed to evaluate whether early administration of PCSK9 inhibitors can effectively improve functional outcomes at 90 days in patients with ischemic stroke (AIS) associated with intracranial atherosclerotic stenosis (ICAS), primarily assessed using the modified Rankin Scale at 90 days.

This multicenter, prospective, randomized controlled trial will evaluate the efficacy and safety of bionic balloon-assisted delivery technology in nulliparous women planning vaginal delivery. Eligible participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. Participants in the control group will receive routine labor management, while participants in the intervention group will receive bionic balloon-assisted delivery in addition to routine labor management after entering the active phase of labor. The primary outcome is the duration of labor, including the first, second, and third stages of labor. Secondary outcomes include intrapartum cesarean conversion rate, intrapartum and postpartum complications, neonatal outcomes, postpartum pelvic floor dysfunction, postpartum depression, and maternal satisfaction. This study aims to determine whether bionic balloon-assisted delivery can shorten labor duration, reduce intrapartum cesarean conversion, and improve maternal and neonatal outcomes without increasing adverse events.

The goal of this multi-center randomized controlled clinical trial is to learn if an individualized, bedside electrical impedance tomography (EIT)-guided ventilation strategy (including EIT-guided prone positioning and PEEP titration) can improve outcomes compared with a conventional lung-protective ventilation strategy in adult patients with acute respiratory distress syndrome (ARDS). The main questions it aims to answer are: Does the individualized EIT-guided ventilation strategy reduce 28-day mortality in ARDS patients? Researchers will compare the EIT-guided intervention arm to a control arm receiving routine lung-protective ventilation (without bedside EIT guidance) to see if the EIT-guided approach lowers 28-day mortality and improves other clinical outcomes. Adult ARDS patients who meet inclusion criteria will be assigned to EIT-guided group and control group through stratified randomization: EIT-guided group: Undergo bedside EIT assessments using a China-manufactured EIT device to guide decisions about prone positioning and individualized PEEP titration (including a recruitment maneuver). Control group: Receive PEEP setting per conventional PEEP-FiO₂ tables and prone positioning per standard clinical indications without EIT guidance. Both groups: Receive standard supportive ICU care and routine outcome assessments at multiple time points. Primary outcome: 28-day mortality. Other outcomes include ventilator-free days to day 28 and so on.

Primary aldosteronism (PA) is the most common cause of secondary hypertension. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is more accurate than the traditional radioimmunoassay method in measuring aldosterone. This study aims to establish a more precise diagnostic cutoff value for the captopril stimulation test (CCT) by measuring aldosterone levels using LC-MS/MS. The investigators will combine the detection results of CCT from healthy volunteers and suspected PA patients, etc., to determine the new CCT cutoff value. The investigators expect to improve the diagnostic accuracy of PA, helping clinicians identify this curable cause of hypertension earlier and more accurately, and achieving precise treatment.

Branch atheromatous disease (BAD)-related stroke is an important subtype of acute ischemic stroke involving penetrating arteries and is associated with early neurological deterioration. Early recognition and standardized diagnosis remain challenging in routine clinical practice because clinical symptoms are often non-specific and the diagnosis requires integrated clinical and imaging assessment. This multicenter prospective observational study will collect demographic, clinical, laboratory, electrocardiographic, ultrasound, and multimodal neuroimaging data from adults with acute ischemic stroke within 1 week of symptom onset. Participants will receive routine clinical care determined by their treating physicians; no treatment or management strategy will be assigned by the study protocol. An independent central clinical-imaging adjudication committee will classify participants as BAD-related stroke or non-BAD acute ischemic stroke according to predefined diagnostic criteria. The study aims to develop and externally validate artificial intelligence-assisted screening and diagnostic models for BAD-related stroke and to evaluate their discrimination, calibration, and potential clinical utility.

This trial is an ongoing single-center, pragmatic, parallel-group randomized controlled superiority trial currently in participant recruiting phase, conducted within intensive care unit teaching wards at Peking Union Medical College Hospital, Beijing, China. The scheduled trial implementation period spans March 2026 to June 2026, aiming to evaluate whether an institution-specific, protocol-bound retrieval-augmented AI educational agent (named ICU-Tutor) can reduce residents' extraneous cognitive load and improve standardized ICU protocol task performance compared with free access to unrestricted commercial general-purpose large language model AI tools during early ICU clinical rotation. The trial plans to screen a total of 44 first-time ICU rotating resident candidates, with pre-defined exclusion standards to eliminate unqualified individuals; approximately 44 eligible residents will undergo 1:1 stratified randomization and be split into two research arms: 22 participants assigned to the ICU-Tutor intervention group and 22 assigned to the unrestricted general AI control group. All enrolled subjects will complete standardized 14-day follow-up assessments as pre-specified in the trial protocol. Both study cohorts receive unified 15-minute standardized training covering standardized safe AI clinical application rules prior to formal intervention initiation. ICU-Tutor is strictly built on a curated knowledge base including 247 ICU institutional protocols validated by senior attending intensivists, with all AI outputs traceable back to original local protocol documents and constrained within verified institutional guidance content only. The control arm allows participants to select and utilize any mainstream general large-model AI tools per personal preference without content or access limitations, consistent with real-world daily resident clinical practice. Two co-primary endpoints are uniformly scheduled to be measured on the 7th day after randomization, including total completion duration of standardized ICU protocol task battery and Paas 9-point validated cognitive load scale score reflecting participants' subjective mental workload during task execution. Three confirmatory secondary endpoints are pre-defined for centralized assessment: composite task performance score on Day7, written institutional protocol knowledge retention score tested on Day14, and 0-100-point visual analog scale (VAS) evaluating resident satisfaction toward allocated AI support on Day7. Individual sub-station scores of three split practical ICU skill modules are set as exploratory secondary endpoints for post-hoc descriptive analysis only. The statistical analysis framework is pre-specified to follow intention-to-treat principle entirely. Analysis of covariance (ANCOVA) is selected as core analytical method for all continuous outcomes, with Day3 baseline assessment result and participants' academic training background set as pre-planned covariates. Bonferroni multiple-testing correction is applied for dual co-primary endpoints, while Benjamini-Hochberg false discovery rate (FDR) correction is pre-specified to control type I error across three confirmatory secondary outcomes. Effect sizes will be quantified via Cohen's d after raw data collection and database lock. The trial has obtained formal ethical approval from the Institutional Review Board of Peking Union Medical College Hospital (Approval ID: I-26ZM0024). Every enrolled resident provides written informed consent before random assignment.

This is a Phase Ib/II clinical study aimed to evaluate the tolerability of becotatugvedotin in combination with gemcitabine, determine the clinically recommended dose for the combination regimen, and assess the efficacy and safety of becotatugvedotin combined with gemcitabine in patients with advanced second-line pancreatic ductal adenocarcinoma (PDAC). The study plans to enroll 27-30 patients, including 3-6 patients in the first stage (Phase I) and 24 patients in the second stage (Phase II). The study consists of three periods: screening period (including baseline), treatment period, and follow-up period (safety follow-up and survival follow-up). Eligible patients must have locally advanced unresectable or metastatic pancreatic cancer confirmed by histopathology. Phase I: After the screening period, patients will receive treatment with becotatugvedotin and gemcitabine. Becotatugvedotin will be administered at doses of 1.5 mg/kg or 2.0 mg/kg once every 3 weeks (Q3W) using a 3+3 dose escalation design. Gemcitabine will be given at 1000 mg/m² on days 1 and 8 of each 3-week cycle (Q3W). Treatment will continue until disease progression, dose-limiting toxicities (DLTs), withdrawal of informed consent, death, pregnancy, investigator decision to discontinue treatment, or study termination, whichever occurs first. Upon completion of Phase I, the study will proceed to Phase II. Phase II: After the screening period, patients will receive treatment with becotatugvedotin and gemcitabine. The dose of becotatugvedotin will be the recommended Phase II dose (RP2D) selected based on the results from Phase I, while gemcitabine will be administered at 1000 mg/m² on days 1 and 8 of each 3-week cycle (Q3W). Treatment will continue until disease progression, intolerable toxicity, withdrawal of informed consent, death, pregnancy, investigator decision to discontinue treatment, or study termination, whichever occurs first. Tumor imaging assessments will be performed using RECIST v1.1 every 6 weeks (i.e., every 2 treatment cycles). Safety assessments will be conducted using the NCI-CTCAE version 5.0 criteria from the first dose through 30 days after the last dose.

This study is designed as a prospective, randomized, open-label, phase II clinical trial to systematically evaluate the efficacy and safety of durvalumab combined with GEMOX/GC chemotherapy followed by lenvatinib, compared with capecitabine monotherapy, as adjuvant therapy for biliary tract cancer (BTC) after curative-intent resection.The primary objective is to determine whether the combination regimen can significantly improve the 1-year recurrence-free survival (RFS) rate. Secondary objectives include assessment of overall survival (OS) and the incidence of treatment-related adverse events. The overall aim is to identify a more effective and safer treatment strategy for postoperative adjuvant therapy in BTC.

The REALVENT trial is designed to evaluate whether a real-time, algorithm-driven ventilation feedback strategy can improve lung-protective ventilation (LPV) achievement rates in critically ill patients receiving invasive mechanical ventilation. This multicentre randomised controlled trial will compare real-time respiratory waveform monitoring with automated feedback against standard ICU care. The primary endpoint is the LPV achievement rate over the first 72 hours.

This phase II study evaluates the efficacy and safety of Trastuzumab Rezetecan in combination with Adebrelimab and Lenvatinib as first-line therapy for patients with locally advanced or metastatic HER2-positive or HER2-low biliary tract cancer. The primary objective is the objective response rate (ORR). Key secondary objectives include efficacy endpoints-progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and duration of response (DoR)-and safety assessments comprising adverse events (AEs), serious adverse events (SAEs), vital signs, and laboratory findings.

The goal of this observational study is to explore the spatial multi-omics mechanism of cachexia in pancreatic cancer and construct a high-precision multimodal intelligent early warning model for its early diagnosis in pathologically confirmed pancreatic ductal adenocarcinoma patients aged ≥18 years with an expected survival of ≥1 month. The main questions it aims to answer are: 1) Can spatial transcriptomics/metabolomics reveal the interaction mechanism between tumor microenvironment and metabolism in pancreatic cancer cachexia? 2)Can a multimodal AI early warning model be built to achieve accurate early identification of pancreatic cancer cachexia? Researchers will compare the surgical cohort and advanced cohort to see the differences in cachexia incidence and progression rules among different subgroups. Participants will complete baseline questionnaires on physical and mental state, nutrition and muscle strength, undergo imaging examinations and provide biological samples (blood, feces, tissue etc.), and receive regular follow-ups for updated questionnaires, imaging rechecks and supplementary biological sample collection until death, loss to follow-up or voluntary withdrawal.