Clinical trials

This prospective, multicenter, observational cohort study enrolls 6,000 adults with sepsis and/or acute respiratory distress syndrome (ARDS) at multiple hospitals in China. Clinical data, treatment information, biological samples, and follow-up data are collected to characterize patient features and outcomes and to establish a multicenter clinical cohort and biobank. The study focuses on the clinical and biological heterogeneity of sepsis and ARDS. Longitudinal clinical data are integrated with information on organ function, inflammatory and immune responses, and multi-omics profiles to identify clinically relevant phenotypes and biological subgroups. Biomarkers associated with disease severity, organ dysfunction, treatment response, and mortality are explored, together with models for outcome prediction. Follow-up after hospitalization evaluates long-term survival and recovery, including pulmonary function, physical function, quality of life, and psychological health.

Sepsis is a life-threatening illness caused by an abnormal response to infection. Some people with sepsis have reduced immune function, which may make recovery more difficult. This study will examine whether adding thymalfasin, also called thymosin alpha-1, to usual sepsis care improves recovery of immune function. The study will enroll 60 adults with sepsis and evidence of reduced immune function at Zhongshan Hospital, Fudan University. Participants will be assigned by chance to one of two groups. Thirty participants will receive usual care plus a 1.6 mg thymalfasin injection under the skin twice daily for 7 days. Thirty participants will receive usual care alone, without study-drug or placebo injections. Participants and treating clinicians will know which treatment is given, but laboratory staff measuring immune outcomes will not know the assigned group. The main outcome is the change in monocyte HLA-DR expression, a blood marker of immune function, between baseline and Day 7. Other assessments include immune cells, organ function, organ support, infections, survival, and safety. Scheduled follow-up continues through Day 90. The study is designed primarily to assess an immune marker; it is not sized to establish a definitive survival benefit.

This is a single-center, prospective, single-arm, open-label study that will enroll 30 adult patients with sepsis at Zhongshan Hospital, Fudan University. All participants will receive CA330 hemoadsorption in addition to standard care. Blood samples will be collected at prespecified time points before hemoadsorption (T0), immediately after completion of hemoadsorption (T1), and approximately 24 hours after completion of hemoadsorption (T2) to evaluate changes in IL-6 and other inflammatory biomarkers. TMT-based quantitative proteomics will be performed on plasma samples collected at T0 and T1 to characterize acute treatment-associated molecular changes and explore their relationships with clinical outcomes.

The objectives of this clinical trial are to explore the feasibility of the eye-tracking communication tool in alleviating communication barriers among non-verbal ICU patients. It will also preliminarily investigate the effectiveness of this tool in facilitating communication for these patients. Researchers will compare the eye-tracking communication tool with conventional techniques (such as body language, writing boards, etc.) to observe the feasibility and preliminary effectiveness of the eye-tracking communication tool in alleviating communication barriers. Participants will use an eye-tracking communication tool for augmentative communication for 2 consecutive days.

Vascular infections are uncommon but severe infections involving the arterial wall, vascular grafts, or endografts, and their diagnosis and management remain challenging. The CAIGIS Cohort is an ambispective observational cohort established at Zhongshan Hospital, Fudan University, to create an integrated clinical research platform and biobank for patients with suspected or confirmed vascular infections. The primary research focus is the diagnosis and characterization of causative pathogens. Conventional microbiological methods and emerging molecular diagnostic technologies will be systematically evaluated, with particular emphasis on blood-based pathogen detection as a form of liquid biopsy and its diagnostic value compared with local tissue or operative specimens. Serial blood samples and tissue specimens, when available, will also be used to investigate biomarkers associated with treatment response and clinical outcomes. Another major focus is the role of molecular imaging, particularly 18F-FDG PET/CT, in the diagnosis and longitudinal assessment of vascular infections. The study will evaluate its diagnostic performance, its added value in patients with inconclusive conventional imaging, and the potential significance of changes in metabolic activity during follow-up for assessing treatment response, residual infection, recurrence, and prognosis. The cohort will further support nested translational studies addressing specific pathogen- and disease-related questions. These include longitudinal characterization of microbial communities in patients with vascular-enteric fistulas; evaluation of the clinical significance and invasive potential of Candida species; investigation of the clinical and biological characteristics of mycobacterial vascular infections; and exploration of pathogen-host interactions within infected vascular tissues. By integrating longitudinal clinical data, microbiological results, molecular diagnostics, PET/CT findings, treatment information, outcomes, and biospecimens, the cohort aims to improve etiological diagnosis, disease stratification, treatment monitoring, prognostic assessment, and understanding of the pathogenesis of vascular infections.

This single-center, ambispective cohort study will use real-world data from Zhongshan Hospital, Fudan University. About 8,000 patients aged 18 years or older with acute myocardial infarction (AMI) who underwent primary percutaneous coronary intervention (PCI) from 2009 to 2028 will be included. Patients will be grouped into four periods: 2009-2013, 2014-2018, 2019-2023, and 2024-2028. The study aims to describe 20-year trends in in-hospital events and major adverse cardiovascular and cerebrovascular events (MACCE) within 2 years after PCI and to identify independent risk factors. The primary outcome is MACCE within 2 years, defined as a composite of all-cause death, recurrent myocardial infarction, ischemia-driven repeat revascularization, and non-fatal ischemic stroke. Key secondary outcomes include in-hospital all-cause death, impaired myocardial perfusion, malignant arrhythmia, acute heart failure, recurrent myocardial infarction, non-fatal ischemic stroke, and bleeding events. Data will come from electronic medical records and the cardiac catheterization database.

Development of an Intelligent System Integrating Preoperative Imaging and Real-Time Intraoperative Metabolic Feedback to Dynamically Optimize Biopsy core Placement for Individualized Precision Sampling.

This is a prospective, single-center, single-arm phase 2 study evaluating the efficacy and safety of neoadjuvant surufatinib plus iparomlimab and tuvonralimab injection and nab-paclitaxel/gemcitabine chemotherapy in patients with high-risk resectable or borderline resectable pancreatic cancer. Approximately 56 participants will be enrolled, including about 19 patients with high-risk resectable disease and 37 patients with borderline resectable disease. Participants will receive up to four 21-day cycles of neoadjuvant treatment. Participants considered eligible for surgery will undergo surgical resection approximately 4 weeks after neoadjuvant treatment. After surgery, adjuvant chemotherapy with either gemcitabine plus capecitabine or modified FOLFIRINOX will be selected by the investigators after multidisciplinary team review. The primary outcome is the 12-month event-free survival rate.

In the intensive care unit (ICU), weaning from mechanical ventilation and extubation are critical clinical goals. Successful extubation not only significantly shortens mechanical ventilation duration but also reduces the incidence of complications such as ventilator-associated pneumonia. However, extubation failure rates remain high, especially in high-risk patient populations. Even after passing the Spontaneous Breathing Trial (SBT), 10%-25% of high-risk patients experience respiratory deterioration post-extubation, necessitating reintubation. Therefore, optimizing extubation strategies for high-risk patients is essential. Currently, extubation techniques in clinical practice are primarily classified into negative pressure extubation and positive pressure extubation. Traditional negative pressure extubation involves continuous tracheal suction to clear secretions; however, this negative pressure can lead to alveolar collapse, regional ventilation mismatch, and an increased risk of aspiration. In contrast, positive pressure extubation maintains airway pressure (such as pressure support or positive end expiratory pressure), which theoretically facilitates the movement of subglottic secretions toward the oropharynx, while also promoting alveolar recruitment and improving ventilation/perfusion matching. Although randomized controlled trials have explored the safety of these two techniques, the conclusions remain controversial. Some studies suggest that positive pressure extubation reduces post-extubation hypoxemia and reintubation rates, while a meta-analysis indicates no statistically significant difference in overall complication rates between the two methods. This discrepancy may arise from heterogeneity in study populations, inadequate standardization of operational parameters, and the limited sensitivity of traditional monitoring methods in detecting regional pulmonary dynamic changes. In recent years, Electrical Impedance Tomography (EIT) and Lung Ultrasound (LUS) have emerged as non-invasive bedside monitoring technologies, offering new insights into the physiological effects of extubation. EIT enables real-time dynamic imaging to quantitatively map both whole-lung and regional ventilation distributions, allowing for the sensitive detection of alveolar collapse or over-expansion. LUS, utilizing its B-line scoring system, provides an objective assessment of lung ventilation loss with high sensitivity and specificity. The combined use of these two techniques not only reveals the effects of extubation on overall oxygenation but also facilitates a detailed analysis of regional ventilation heterogeneity and compensatory mechanisms, thereby offering multimodal data to optimize extubation strategies. This study proposes the design of a single-center, prospective, randomized controlled trial to systematically assess the physiological differences between positive pressure and negative pressure extubation techniques in high-risk patients prone to extubation failure. The goal is to provide evidence-based support for developing individualized extubation strategies tailored to high-risk patients.

This prospective randomized two-period crossover reader study will evaluate whether assistance from a frozen artificial intelligence model improves physicians' interpretation of the anaerobic threshold (AT) in cardiopulmonary exercise testing (CPET). Sixteen physicians, including 8 senior and 8 junior readers, will each interpret 150 de-identified CPET examinations once without AI assistance and once with AI assistance. The primary outcome is the within-physician difference in absolute AT localization error between the assisted and unassisted conditions. Secondary outcomes include signed timing error, agreement on whether AT is present, estimates within 15 and 30 seconds of the reference, inter-reader reliability, interpretation time, and whether the effect of AI assistance differs by physician seniority.

Cardiopulmonary exercise testing requires clinicians to integrate multiple physiological measurements and explain their meaning, limitations, safety implications, and appropriate next steps. This randomized two-period crossover study will evaluate whether physician-supervised GPT-assisted drafting preserves the clinical acceptability of final patient-facing responses while reducing task completion time compared with physician-only drafting. Licensed physicians or institutionally recognized clinical trainees will respond in Chinese to 20 synthetic cardiopulmonary exercise testing scenarios. Each participant will complete 10 scenarios in each condition using two non-overlapping case sets. In the GPT-assisted condition, a frozen model-generated draft will be displayed and may be edited, deleted, or completely rewritten by the physician. The primary hypothesis is that GPT-assisted drafting is noninferior to physician-only drafting for clinical acceptability, using a noninferiority margin of 5 percentage points. Completion time will be evaluated for superiority only if noninferiority is established.

This study evaluates the effectiveness and safety of targeted therapy given before and after surgery in patients with resectable or potentially resectable stage III non-small cell lung cancer with selected genetic alterations. Treatment is assigned according to tumor genetic findings.

Obesity is a chronic, progressive, and relapsing disease. Although lifestyle interventions and anti-obesity medications are effective for inducing weight loss, evidence regarding their role in long-term weight maintenance after pharmacologically induced weight reduction remains limited. In addition, the high cost and potential adverse effects of weight-loss medications restrict their prolonged use, and it is unclear whether low dose medication, intensive life style intervention or together can serve as an effective strategy for weight maintenance. This randomized controlled trial aims to evaluate the effectiveness of a 1-year intensive lifestyle intervention, a reduced dose of mazdutide (3.0 mg once weekly), or their combination in weight maintenance among individuals with obesity who have achieved initial weight loss after intensive treatment with high dose mazdutide. The study seeks to provide high-quality clinical evidence to inform long-term weight maintenance strategies after weight loss in patients with obesity.

This study will evaluate whether adding rimegepant to standard neoadjuvant chemoimmunotherapy can improve treatment response in patients with primary or recurrent oral or oropharyngeal squamous cell carcinoma who are planned to undergo surgery. Rimegepant blocks the receptor for calcitonin gene-related peptide, also known as CGRP. CGRP signaling may affect the tumor immune environment and the response of tumors to anticancer treatment. The study includes an initial safety run-in stage involving 20 participants, followed by a randomized controlled stage involving 200 participants. During the randomized stage, participants will be assigned in a 1:1 ratio to receive standard neoadjuvant chemoimmunotherapy either with or without rimegepant. All participants will receive two cycles of neoadjuvant treatment followed by definitive or intended curative surgery. The main outcome is the major pathological response rate, defined as 10% or less residual viable tumor in the surgical specimen. Other outcomes include pathological complete response, objective response, event-free survival, overall survival, changes in pain and quality of life, and treatment safety.

Coronary atherosclerotic disease remains one of the leading causes of mortality and morbidity worldwide. Although percutaneous coronary intervention (PCI) and drug-eluting stents (DES) implantation has significantly improved clinical outcomes, long-term studies have demonstrated that stent-related complications-including late restenosis, very late thrombosis, impaired vascular compliance due to permanent metal residue, and bleeding risk associated with prolonged dual antiplatelet therapy (DAPT)-have yet to be fundamentally resolved. Drug-coated balloon (DCB) has emerged as a "metal-free" alternative strategy, delivering antiproliferative drugs to the vessel wall during balloon expansion, with the aim of reducing metal residue, promoting vascular healing, and lowering the incidence of long-term adverse events. Multiple high-quality studies have validated the safety and efficacy of DCB in the setting of in-stent restenosis (ISR) and small-vessel de novo lesions. The international DCB consensus has explicitly incorporated ISR and small-vessel disease into the category of established indications. Recent studies have demonstrated that, in small-vessel lesions, DCB is comparable to second-generation DES with respect to target lesion revascularization (TLR) and major adverse cardiovascular events (MACE), while conferring a lower risk of long-term stent-related complications. These advances have prompted relevant expert panels to publish operational standards and indication guidelines for DCB. Meanwhile, the research focus of DCB is gradually expanding toward "large-vessel de novo lesions." This lesion subset is typically characterized by a reference vessel diameter ≥2.75-3.0 mm, high lesion burden, and impaired vascular compliance. Several international studies have found that, under conditions of adequate lesion preparation-defined as residual stenosis \<30%, absence of severe dissection, and sufficient lesion expansion-DCB treatment of large-vessel de novo lesions can yield satisfactory outcomes. China has rapidly followed suit, with experts revising the national expert consensus in 2024 to refine the application of drug-coated balloons in coronary stenotic lesions. Owing to the absence of permanent metallic stent residue and the short duration of local drug action, DCB theoretically permits the use of a less intensive antiplatelet regimen. However, clinical trial evidence regarding the optimal antiplatelet strategy following DCB treatment remains lacking. This study aims to investigate whether, among patients with chronic coronary syndrome (CCS) undergoing DCB treatment, 1 month of dual antiplatelet therapy post-procedure is non-inferior to 6 months of dual antiplatelet therapy with respect to target vessel failure (TVF) at 1 year.

This prospective, open-label, multicenter randomized controlled trial will compare two preprocedural imaging assessment strategies in adults with nonvalvular atrial fibrillation who are scheduled to undergo percutaneous left atrial appendage closure (LAAC). Participants will be randomized 1:1 to a transesophageal echocardiography (TEE)-guided strategy or a cardiac computed tomography angiography (CCTA)-guided strategy for assessment of left atrial appendage anatomy and selection of the occluder type and size. LAAC and postprocedural management will otherwise follow routine clinical practice. The primary outcome is a composite of serious periprocedural safety events through 30 days. At 3 months (plus or minus 2 weeks), participants who undergo LAAC will receive both TEE and CCTA for blinded core-laboratory assessment of peridevice leak, device-related thrombus, and residual left atrial appendage patency. Clinical follow-up will continue through 12 months.

The goal of this observational study is to evaluate the safety and efficacy of systemic therapies and identify predictive molecular biomarkers in patients with intermediate to advanced stage or unresectable hepatocellular carcinoma (HCC). The main questions it aims to answer are:What is the objective response rate (ORR) of systemic therapy regimens in this patient population? Which 3-4 specific biomarkers (including tumor or peripheral blood-derived genes, proteins, ctDNA, and immune cell subsets) can reliably predict the efficacy of systemic treatment?

To investigate the diagnostic performance of Femtosecond Laser Label-Free Imaging combined with artificial intelligence for predicting high-risk pathological features in lung cancer

To investigate the diagnostic efficacy of Femtosecond Laser Label-Free Imaging combined with artificial intelligence-assisted diagnosis for rapid diagnosis of lung cancer.

To evaluate the safety and efficacy of HRS-4642 in combination with immunotherapy and chemotherapy in borderline resectable, locally advanced/metastatic pancreatic cancer

Brief Summary (Plain Language) The purpose of this clinical trial is to evaluate and compare the effects of four different intervention measures on preventing and managing postoperative gastrointestinal dysfunction in patients with primary liver cancer. The four measures include herbal acupoint application, transcutaneous acupoint electrical stimulation, the combination of the above two acupoint stimulation methods, and routine clinical nursing. This study aims to provide scientific evidence for the clinical application of acupoint stimulation therapies in postoperative rehabilitation of liver cancer patients. The main research question of this study is whether acupoint stimulation interventions can effectively improve postoperative gastrointestinal recovery in primary liver cancer patients. The primary outcome measure is the time to first postoperative anal exhaust, which is a core indicator to reflect the recovery of gastrointestinal function after surgery. By comparing the differences in gastrointestinal recovery among the four groups, this trial will clarify the optimal acupoint intervention scheme to prevent and relieve postoperative gastrointestinal dysfunction in primary liver cancer patients, so as to improve patients' postoperative rehabilitation quality.

EGFR-TKI has firmly established itself as a first-line treatment for advanced lung cancer with EGFR-sensitive mutations, and the ADAURA study has added to its indications for use as postoperative adjuvant therapy in early- and mid-stage lung cancer.However, clinical data on neoadjuvant EGFR-TKI therapy are still incomplete. A phase II clinical study, CTONG1103, currently ongoing, comparing the efficacy of the first generational EGFR-TKI erlotinib and gemcitabine combined with cisplatin as neoadjuvant therapy for stage IIIA-N2 EGFR mutation-positive non-small-cell lung cancer, did not yield significantly positive objective remission rate (ORR) results. Furmonertinib is a third-generation Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets Epidermal Growth Factor Receptor (EGFR) mutations.Furmonertinib demonstrates definite efficacy and favorable safety in first-line EGFR-sensitive mutations and EGFR T790M Mutations in second-line and late-line treatment of advanced NSCLC.The aim of this study was to explore the efficacy and safety of furmonertinib neoadjuvant therapy for resectable stage II-IIIB EGFR-sensitive mutant non-small cell lung cancer efficacy and safety. Patinents are planned to be recruited from five centers in China. Eligible patients will receive furmonertinib neoadjuvant therapy for 8 weeks to evaluate the efficacy and safety of furmonnertinib neoadjuvant.

This multicenter randomized controlled trial evaluates antithrombotic strategies post-TAVR in severe aortic regurgitation patients without long-term anticoagulation. Patients are randomized 1:1 to aspirin 75-100 mg daily for 12 months versus warfarin (INR 2-3) for 6 months followed by aspirin for 6 months. Primary hypothesis: aspirin is superior for bleeding and non-inferior for death/thrombosis. Primary endpoint is a composite of death, stroke, thrombosis, MI, embolism, and major bleeding at 1 year. Sample size: 1172. Follow-up: 30 days, 6 months, 12 months.

The goal of this observational study is to learn whether family members can help identify signs of delirium in adult patients who are staying in the intensive care unit. Delirium is a sudden change in attention, thinking, or awareness that can happen during serious illness. The main question it aims to answer is: Can family members notice possible signs of delirium that may not be found during routine ICU delirium screening? Participants will receive their usual medical care. Family members who know the patient well will complete a short delirium assessment called the FAM-CAM after visiting the patient. Nurses will continue to perform routine ICU delirium screening using the ICDSC as part of usual care. The study team will compare the family member's assessment with the nurse's routine assessment to see whether family observations provide additional helpful information. Family members may complete the assessment for up to 3 days while the patient is in the ICU.

This prospective observational study will evaluate how accurately three-dimensional electrical impedance tomography (3D-EIT) measures the distribution of air in the lungs during breathing when compared with four-dimensional computed tomography (4D-CT). 3D-EIT is a noninvasive, radiation-free imaging method that measures changes in electrical impedance across the chest and can provide continuous information about regional lung ventilation. In this study, 4D-CT will be used as the reference method because it can provide detailed images of changes in the lungs throughout the breathing cycle. Approximately 50 adults, including healthy volunteers and hospitalized patients who are able to undergo both examinations, will be enrolled at a single center. EIT and CT data will be collected at the same time during stable breathing. Researchers will compare the two methods to determine how closely their measurements of ventilation in different lung regions agree. The study will also explore whether EIT can detect changes in regional ventilation under different breathing conditions. The study will not use the research EIT results to make clinical treatment decisions. The findings may support the future use of EIT as a noninvasive, radiation-free method for monitoring regional lung ventilation.