Clinical trials

The goal of this observational study is to learn if combining information from CT scans, blood tests, and pathology reports can better predict how pancreatic cancer will progress. The main questions it aims to answer are: * Can combining these types of data more accurately estimate how long a person might survive? * Can it better predict the risk of recurrence? Participants will not have any extra tests or treatments. They will: * Allow researchers to collect information from their existing medical records (such as surgery reports, imaging, and lab results) * Receive a follow-up phone call for up to 3 years to share health updates（about every 3 months for the prospective cohort）.

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.

This single-center randomized controlled trial will evaluate whether real-time visual feedback from electrical impedance tomography (EIT) improves the immediate distribution of lung ventilation during incentive spirometry in adults with postoperative atelectasis. Approximately 60 participants will be randomized 1:1 to receive either EIT-guided visual feedback or standardized verbal guidance during one session of 30 incentive-spirometry breaths. The primary outcome is the change in dorsal ventilation fraction from before training to 5 minutes after training. Secondary outcomes include inspiratory capacity, ventilation homogeneity, dependent silent spaces, end-expiratory lung impedance, oxygenation, in-hospital intubation or reintubation, and intervention-related adverse events.

Some patients may have problems with memory, attention, thinking speed, or other cognitive functions after leaving the intensive care unit (ICU). This is called post-ICU cognitive impairment. Early recognition of this problem may help clinicians provide follow-up care and support more promptly. This study will explore whether eye-tracking technology can help identify cognitive impairment in patients soon after ICU discharge. Eye tracking is a non-invasive test that records eye movements while a person looks at images or completes simple visual tasks on a screen. The test does not involve any treatment or change in usual medical care. Participants will be adult patients who have been transferred from the ICU to a general ward. Within 7 days after ICU discharge, participants will complete a cognitive assessment and an eye-tracking test. The study team will also collect relevant clinical information from medical records. Patients will be grouped according to whether they have post-ICU cognitive impairment based on cognitive assessment and clinical judgment. The main purpose of this study is to assess whether information obtained from eye-tracking tests can help clinicians identify possible post-ICU cognitive impairment at an early stage, when used together with standard cognitive assessment. The study will also compare eye movement patterns between the two groups and explore whether eye-tracking measures add useful information beyond standard cognitive assessment.

This is a prospective, observational cohort study (MIND-PANC) to explore the associations of chronic psychological stress with disease progression, treatment outcomes, and prognosis of pancreatic cancer. Researchers will ask participants to fill out simple questionnaires about their mood, worries, and sleep at the start of the study and at regular follow-up visits. The study will also collect a small blood sample (leftover from routine care) to measure stress-related markers. Investigators hypothesize that pancreatic cancer patients who have higher levels of ongoing psychological stress (such as anxiety, depression, or poor sleep) tend to have shorter survival times, a higher chance of recurrence, and a poorer response to treatment, compared to patients with lower stress levels.

This study is a randomized, double-blind, placebo-controlled trial aimed at exploring the effects of LAE102 injection in combination with Tirzepatide on body composition.

This prospective, randomized, open-label, blinded endpoint (PROBE) trial evaluates the efficacy of early ertugliflozin initiation (10 mg daily) compared to standard care alone on cardiac function in 476 adult patients with type 2 diabetes mellitus (T2DM) following a first acute myocardial infarction (AMI). The study is supported by scientific rationale suggesting potential effects of ertugliflozin on cardiac resident macrophages in the heart after myocardial infarction.The primary objective is to assess the change in NT-proBNP levels from baseline to 26 weeks, while secondary endpoints explore echocardiographic parameters (such as LVEF and LAVi) and metabolic indices including blood ketone levels, HbA1c, and body weight. Eligible participants are randomized in a 1:1 ratio within 72 hours of AMI onset and followed for a total of 30 weeks to monitor both efficacy outcomes and safety events, with a specific focus on serious adverse events like severe hypoglycemia, genital infections, and ketoacidosis.

Primary Objective of the trial is to evaluate the efficacy and safety of Isa-VRd-based regimen in transplant-ineligible newly diagnosed multiple myeloma (TI-NDMM) patients receiving treatment in real-world clinical practice in China. And Secondary Objectives is， To assess the MRD negativity rate in Chinese TI-NDMM patients treated with Isa-VRd To assess the safety and tolerability of Isa-VRd in Chinese TI-NDMM patients Participants will: Receive Isatuximab 10 mg/kg iv * Cycle 1: Every weeks on Days 1, 8, 15, and 22 * Cycles 2-8: Every 2 weeks on Days 1 and 15 Receive Bortezomib subcutaneous injection 1.3 mg/m² * Cycles 1-8: Days 1, 8, and 15 of each cycle Receive Lenalidomide oral 25 mg/day * Cycles 1-8: Days 1-21 at 25 mg/day (10 mg/day for patients with creatinine clearance \[CrCl\] ≥30 and \<60 mL/min) Receive Dexamethasone oral 20 mg * Cycles 1-8: Days 1, 8, 15, and 22 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen During the induction phase, efficacy assessment is recommended at each treatment cycle. Patients who achieve ≥CR at the end of induction are recommended to undergo the first MRD monitoring assessment. During the maintenance phase, efficacy assessment is recommended at least every 3 cycles. Patients are recommended to undergo MRD status monitoring (≥CR) every 6 months (i.e., at months 14, 20, and 26) for MRD assessment. During the follow-up period, MRD status monitoring (≥CR) is recommended every 12 months to observe the depth of response.

Brief Summary Lymph node metastasis (LNM) is a key factor influencing treatment decisions and prognosis in patients with gastric cancer. Lymphatic invasion (LI) is an important pathological predictor of LNM and a core component of the eCURA risk scoring system after endoscopic submucosal dissection (ESD) for early gastric cancer. However, whether LI has the same predictive value for LNM across different mismatch repair (MMR) statuses remains unclear. Compared with proficient mismatch repair (pMMR) gastric cancer, deficient mismatch repair (dMMR) gastric cancer has distinct molecular pathological features and an immune-enriched tumor microenvironment. In early gastric cancer, if LI is associated with a lower LNM risk in dMMR tumors than in pMMR tumors, existing LI-based eCURA risk assessment may overestimate LNM risk in patients with dMMR early gastric cancer and consequently affect decisions regarding additional surgery after ESD. Therefore, this study aims to systematically evaluate the impact of MMR status on the association between LI and LNM using upfront-surgery and post-ESD additional-surgery cohorts from our center, and to explore the potential clinical value of MMR status in refining eCURA-based risk stratification for early gastric cancer.

STEMI represents the subtype of ACS with the worst prognosis, associated with high mortality and an elevated risk of complications. The use of IVI guidance holds the potential to reduce the incidence of MACE. In previous studies, there has been limited research on intravascular imaging in the context of primary revascularization procedures for STEMI, and no large-scale cohort study has compared the differences in clinical outcomes between IVI-guided and angiography-guided primary revascularization. Therefore, we conducted this large-scale randomized controlled trial to compare IVI-guided primary PCI versus coronary angiography-guided primary PCI in patients with STEMI.

This study is a randomized, blank-controlled, open-label, single-dose, dose-escalation clinical study of rhKGF-2 in patients with ARDS. The trial is designed with three dose groups (5 mg, 10 mg, and 15 mg), which will be escalated sequentially from the lowest dose group to the highest dose group. Each dose group will enroll 8 subjects, randomized in a 6:2 ratio according to the order of enrollment, to receive either the corresponding dose of rhKGF-2 (6 subjects) or serve as a blank control (2 subjects). Each subject will receive a single dose, administered once via a disposable bronchoscopic catheter. All subjects will receive the trial intervention on top of standard ARDS treatment (see Concomitant Medications for details). Following the completion of drug administration, subjects will enter a 28-day follow-up period. Outcome measures include adverse events (AE), vital signs, laboratory parameters, oxygenation index (PFR), chest imaging changes, etc., to evaluate the safety, tolerability, and efficacy of the treatment.

This is a single-arm, phase II clinical study designed to evaluate the efficacy and safety of a recombinant PD-1/IL-2 bispecific antibody, as neoadjuvant therapy in hepatocellular carcinoma (HCC) patients who experienced early recurrence after curative hepatectomy and were suitable for repeat surgical resection. A total of approximately 30 eligible participants are planned to be enrolled. All patients will receive neoadjuvant treatment with PD-1/IL-2 bispecific antibody for 3 cycles. Curative re-resection will be performed 2 to 7 weeks after the last dose of PD-1/IL-2 bispecific antibody for patients with resectable lesions confirmed by imaging assessment. Tumor evaluation will be conducted per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) throughout the study. Postoperative pathological assessment and long-term follow-up will be implemented after surgery. The primary endpoint is the major pathological response (MPR) rate. Secondary endpoints include complete pathological response (pCR) rate, event-free survival (EFS), overall survival (OS), R0 resection rate, objective response rate (ORR), disease control rate (DCR), and the safety and tolerability profile . Exploratory endpoints aim to analyze the correlation between biomarkers (e.g., PD-L1 expression, tumor microenvironment) and treatment efficacy. This study intends to explore the clinical value of PD-1/IL-2 bispecific antibody in the neoadjuvant setting for recurrent resectable HCC, and provide evidence for its clinical application in this patient population.

This study aims to find out if an artificial intelligence (AI) system can help experienced radiologists write chest CT scan reports more quickly without lowering the quality of the report. Chest CT scans are common, and writing reports for them is a major part of a radiologist's job. In this trial, board-certified radiologists will interpret complex chest CT cases. For some cases, they will start with a complete draft report generated by the AI system, which they can review and edit as needed. For other cases, they will write the report from scratch without any AI help, following their usual routine. The main things we are measuring are: 1) how much time the AI draft saves, and 2) whether the final reports created with AI help are as good as or better than those written without it, as judged by other senior doctors who do not know which report came from which method. The hope is that this AI tool can make radiologists' work more efficient while maintaining high standards for patient care.

The goal of this observational study is to learn if an AI assistant tool can help doctors who read chest CT scans (called radiologists) write their reports faster and just as well or better. Chest CT scans are common pictures taken of the inside of the chest to help with diagnosis. The main questions the study aims to answer are: (1) Does using the AI tool save radiologists time when writing their reports? (2) Are the final reports written with the AI tool's help as good as or better than reports written without it? To answer these questions, researchers will compare two time periods at several hospitals. They will look at how long it took to write reports and how good the reports were, both from a time before the AI tool was available and from a time after it was in regular use. In this study, radiologists will use the AI tool as part of their normal daily work. The tool is built into the computer system they already use to look at scans. Researchers will then measure the time and quality of the reports produced during their regular shifts.

The goal of this clinical trial is to learn if teclistamab in combination with daratumumab (Tec-Dara) works to treat newly diagnosed multiple myeloma with concurrent light chain amyloidosis (MM+AL). It will also learn about the safety of this combination. The main questions it aims to answer are: Does Tec-Dara improve the 1-year progression-free survival rate compared to historical data (50% to 75%) in MM+AL patients? What are the rates of hematologic response (ORR, VGPR, CR, MRD negativity) and organ response in MM+AL patients treated with Tec-Dara? What medical problems do participants have when taking Tec-Dara? Participants will: Receive teclistamab subcutaneous injection with step-up dosing (0.06, 0.3, 1.5 mg/kg), followed by 1.5 mg/kg weekly in Cycle 1, 3.0 mg/kg every 2 weeks in Cycles 2-3, and 3.0 mg/kg every 4 weeks in Cycles 4-24 Receive daratumumab subcutaneous injection 1800 mg weekly in Cycles 1-2, every 2 weeks in Cycles 3-6, and every 4 weeks in Cycles 7-24 Continue treatment until disease progression, unacceptable toxicity, or a maximum of 24 cycles Undergo disease assessments every 28 days (±7 days) including laboratory tests for hematologic and organ response evaluation Provide bone marrow samples for MRD and RNA sequencing analysis

For locally advanced gastric adenocarcinoma/esophagogastric junction adenocarcinoma, the currently recommended treatment strategy per clinical guidelines is radical gastrectomy combined with perioperative therapy (including chemotherapy, immunotherapy, etc.). This approach involves several cycles of neoadjuvant therapy prior to surgery, followed by the surgical procedure, and then several cycles of adjuvant therapy post-surgery. This regimen is generally considered to offer favorable efficacy, ultimately leading to improved survival outcomes for patients. However, some patients are unable to complete the prescribed postoperative adjuvant therapy due to factors such as poor physical condition after surgery or cumulative treatment toxicity. Findings from the retrospective SPACE-FLOT study preliminarily suggest that for patients with a favorable response to neoadjuvant therapy, postoperative adjuvant therapy may not confer additional survival benefit, while potentially increasing the risk of treatment-related adverse events. Therefore, the investigators aim to utilize the latest technological approaches to identify patients who could safely forgo adjuvant therapy, enabling personalized treatment decisions, reducing unnecessary treatment, and thereby maximizing patients' long-term survival benefits. To achieve this objective, the investigators have identified circulating tumor DNA (ctDNA) testing as a potential solution. ctDNA refers to DNA fragments released by tumor cells into the extracellular space (e.g., into the bloodstream). By drawing a small amount of peripheral blood and analyzing the ctDNA within, it is possible to detect minimal residual disease (MRD) that is difficult to identify through conventional imaging methods (such as CT or MRI) after treatment. MRD is considered a critical factor that may lead to tumor recurrence. Utilizing ctDNA to detect MRD enables a convenient and accurate assessment of tumor status and treatment efficacy, thereby offering the potential for personalized treatment. Colorectal cancer represents a cancer type where ctDNA testing has been applied early and is relatively mature. In the field of colorectal cancer, the GALAXY study confirmed that ctDNA positivity can effectively predict patient survival outcomes, with superior performance to other traditional indicators. The study also found that patients with postoperative ctDNA MRD positivity tended to benefit from postoperative adjuvant chemotherapy, whereas those with ctDNA MRD negativity often did not derive such benefit. Subsequently, another randomized controlled trial (the DYNAMIC study) revealed that using ctDNA MRD to guide postoperative adjuvant chemotherapy strategies could effectively reduce unnecessary chemotherapy without adversely impacting patient survival outcomes. In the field of gastric cancer, studies such as MENCA-GC, CRITICS, and PLAGAST have all demonstrated that postoperative ctDNA can effectively predict patient prognosis in the treatment model of radical gastrectomy combined with perioperative therapy. Additionally, preliminary findings from the ongoing MRD-GATE study indicate that in treatment models without preoperative neoadjuvant therapy (i.e., surgery followed by adjuvant therapy), utilizing ctDNA MRD to guide postoperative adjuvant treatment can also reduce unnecessary chemotherapy without compromising patient survival outcomes. This study focuses on patients with locally advanced gastric cancer, integrating the latest clinical research advancements, and aims to fill the research gap concerning the efficacy of using ctDNA MRD to guide adjuvant therapy within the context of radical gastrectomy combined with perioperative therapy. This holds significant importance for optimizing treatment strategies and maximizing patient benefits.

BTC-Ag-T (ACH-AgT001) is an autologous experimental T-cell therapy designed for advanced biliary tract cancer. This is an open-label, single-arm Phase 1 study to evaluate the safety, tolerability, and preliminary efficacy of BTC-Ag-T in patients with advanced, unresectable, or metastatic biliary tract cancer who have failed standard-of-care therapy.

Polycystic ovary syndrome (PCOS) is the most common reproductive endocrine and metabolic disorder among women of reproductive age. It is characterized by oligo-ovulation or anovulation, clinical and/or biochemical hyperandrogenism, and polycystic ovarian morphology. In addition, PCOS is frequently accompanied by multiple metabolic abnormalities, including insulin resistance, obesity, impaired glucose tolerance, and dyslipidemia. Clinical studies have demonstrated that treatment with glucagon-like peptide-1 receptor agonists (GLP-1RAs) in women with PCOS results in significant weight reduction, decreased free testosterone levels, improvement in menstrual regularity, and increased clinical pregnancy rates. Fibroblast growth factor 21 (FGF21) has been shown to enhance insulin sensitivity, promote fatty acid oxidation, and improve lipid distribution. HEC88473 is a novel long-acting dual agonist targeting both the glucagon-like peptide-1 (GLP-1) receptor and the fibroblast growth factor 21 (FGF21) receptor. This study is initiated to evaluate the clinical efficacy of HEC88473 in women with PCOS and to explore its potential as a new therapeutic option for the management of PCOS.

The goal of this observational study is to evaluate the diagnostic performance of angiography-derived microcirculatory indices (Angio-IMR) in assessing patients with stable angina or suspected coronary artery disease. The main questions it aims to answer are: How do the numerical values of Angio-IMR from five different software vendors change across three physiological states (resting, sub-hyperemia induced by nitroglycerin, and maximal hyperemia induced by adenosine)? Which physiological state and software algorithm provide the highest diagnostic accuracy (Area Under the Curve, AUC) for diagnosing Coronary Microvascular Disease (CMD) when compared to the gold standard wire-based IMR? Researchers will compare the Angio-IMR results calculated under the three different physiological conditions within the same patient to see how the hyperemic state impacts the performance and consistency of these non-invasive indices. Participants will: Undergo standard-of-care coronary angiography and physiological assessment using a pressure wire for index of microvascular resistance (Wire-IMR) as part of their clinical management. Have their angiographic images captured at three specific time points: at rest, after intracoronary nitroglycerin, and during adenosine-induced maximal hyperemia. Allow their de-identified imaging and clinical data to be analyzed by an independent core laboratory using five different Angio-IMR software platforms to evaluate microvascular function.

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.

To provide evidence-based medical evidence for the optimized combination strategy of local and systemic therapies.

This study aims to explore the safety and efficacy of oral administration of a novel anticoagulant (rivaroxaban) in patients with cirrhosis accompanied by high-risk esophagogastric variceal bleeding and portal vein thrombosis, through a prospective, multicenter, randomized controlled clinical trial, starting 48 hours after endoscopic treatment to prevent rebleeding.

This study is a single-center, prospective cohort study based on real-world data. Patients with portal hypertension and esophagogastric varices were enrolled and divided into an endoscopic treatment group and a non-endoscopic treatment group (including patients receiving medical therapy, interventional procedures, or surgical treatment) according to whether they underwent endoscopic intervention. Baseline data, serum metabolites, CT imaging and endoscopic images, liver biopsy pathology, and other multi-omics data were integrated for both groups. Patients were followed up to compare adverse events after variceal treatment, including rebleeding and its causes, hepatic encephalopathy, ascites, subsequent treatments (such as regular endoscopic therapy, NSSB, and TIPS), and survival outcomes. Clinical characteristics of portal hypertension attributed to different etiologies, including hepatitis B, autoimmune liver disease, schistosomiasis, hematological disorders, and chemotherapy-induced liver injury, were compared. The efficacy and safety of endoscopic and interventional treatments for esophagogastric varices were evaluated. Factors influencing rebleeding rates among different treatment groups were analyzed, and reasons for inclusion in different groups were discussed.

Why This Study Is Important * Many patients with atrial fibrillation (AF) continue to experience abnormal heart rhythms even after receiving standard treatments. * Standard heat-based energy can be difficult to use in these areas because fast blood flow cools the tissue, and excessive heat may damage nearby structures like the right coronary artery. Our Approach * Investigators are testing a newer technology called pulsed field ablation (PFA). * Unlike traditional methods, PFA uses ultra-short electrical pulses rather than heat to target heart cells specifically while protecting neighboring nerves and blood vessels. * This study focuses on applying this energy within the coronary sinus to help achieve a more complete and lasting electrical block for the mitral isthmus. What To Expect * This study involves 30 participants who are already undergoing a catheter ablation procedure for atrial fibrillation. * The research team will monitor how successful the procedure is at immediately stopping the abnormal electrical signals. * Participants will have follow-up visits over six months to check for any returning heart rhythm issues and will receive a specialized heart scan (CTA) to ensure the nearby coronary arteries remain healthy

This study is a prospective, single-arm, single-center trial evaluating the efficacy of TACE combined with multimodal ablation, Tislelizumab, and lenvatinib in the treatment of unresectable primary liver cancer.