Clinical trials

The goal of this clinical trial is to evaluate the efficacy and safety of AK112 combined with the GAP regimen as conversion therapy for patients with locally advanced gallbladder cancer who are initially considered unsuitable for curative surgery. The main questions this study aims to answer are: 1. Whether AK112 combined with the GAP regimen can increase the rate of successful R0 radical resection after conversion therapy. 2. Whether this treatment approach can achieve tumor response and disease control with acceptable safety in patients with locally advanced gallbladder cancer. Participants will receive AK112 combined with gemcitabine, cisplatin, and albumin-bound paclitaxel (GAP regimen) every 21 days for 4-6 treatment cycles. Tumor response will be evaluated by CT or MRI according to RECIST version 1.1 criteria. Patients who become eligible for surgery after multidisciplinary evaluation will undergo radical resection. All participants will be monitored for treatment-related adverse events, disease progression, and survival outcomes during follow-up.

This prospective multi-cohort observational study evaluates the association between peripheral blood lipidomic and ceramide profiles and atrial fibrillation. The study hypothesis is that peripheral blood lipidomic features and ceramide-related profiles are associated with the presence of atrial fibrillation. Participants with atrial fibrillation and control participants with other cardiovascular diseases will be prospectively enrolled. Peripheral blood samples will be analyzed using untargeted lipidomic profiling in one cohort and targeted ceramide assays in another cohort.

The aim of this study is to investigate the effects of remote ischaemic preconditioning on the peripheral blood characteristics of healthy adults and to explore the possible mechanisms for improving ischaemia/reperfusion injury and its protective effects on the cardiovascular system.

The purpose of this clinical trial is to understand whether the drug Ursodeoxycholic acid (UDCA) can prevent glucose intolerance in participants with hyperlipidemia who are taking statins. It will also assess the safety of UDCA. The primary questions it aims to answer are: * Will UDCA reduce the incidence of glucose intolerance in participants taking oral statins? * Will the use of UDCA decrease other adverse events in patients taking oral statins? Participants will: * Take Atorvastatin combined with UDCA or a placebo daily for 6 months * Have follow-up visits on day 40, day 110, and day 180 Have their examination indicators recorded.

Study participants will be prospectively recruited from consecutive outpatient and inpatient populations presenting to the Cardiology and Cardiac Surgery Departments of the following participating institutions: The First Affiliated Hospital of Xi'an Jiaotong University, The Second Affiliated Hospital of Xi'an Jiaotong University, and \[add additional participating institutions as applicable\].

The goal of this clinical trial is to learn if adding standardized manual thrombus aspiration to primary percutaneous coronary intervention (PPCI) works better to improve heart health outcomes and protect long-term heart function in adults with acute ST-segment elevation myocardial infarction (STEMI) and a high blood clot burden in the heart's arteries. The main questions it aims to answer are: * Does PPCI plus manual thrombus aspiration lower the risk of serious heart problems one year after treatment, compared to PPCI alone? * Can manual thrombus aspiration better protect long-term heart function in people with a high blood clot burden? Researchers will compare two groups of participants-one group getting PPCI plus manual thrombus aspiration and one group getting only PPCI-to see if the aspiration treatment leads to fewer serious heart problems, better long-term heart function, and similar safety (including no higher risk of stroke). Participants will: * Have a heart artery scan (coronary angiography) to confirm a high blood clot burden * Be randomly assigned to one of the two treatment groups for their PPCI procedure * Complete follow-up checks at 30 days, 6 months, and 1 year after treatment, including heart function tests (like echocardiograms) * Have heart magnetic resonance (CMR) scans if selected, to measure heart tissue damage and heart function * Have their heart health status and any adverse events recorded throughout the study

To explore the efficacy and safety of thiotepa combined with melphalan for ASCT conditioning in patients with multiple myeloma who did not acheive CR with or without extramedullary inflitration before transplantation. After screening and enrollment, the patients were randomly divided into two groups according to 1:1, and the experimental group received the following drug treatments: the total amount of thiotepa was 10mg/kg, D-4 to -3; melphalan 140mg/m2, D-2. The control group received melphalan 200mg/m2, D-2 (the dose of the drug was adjusted according to the glomerular filtration rate). The two groups of D0 infused hematopoietic stem cells.G-CSF and TPO or TPO-RA were allowed to use to promote hematopoietic stem cell engraftment.Platelet and red blood cell transfusions were allowed if necessary. Efficacy of the therapy was evaluated 1 month after the end of transplantation, and the follow-up evaluation was carried out every 3 months, and the relapse rate was evaluated until 1 year after transplantation.

Study Title: Multicenter, Randomized Controlled Clinical Study on Early Application of Realgar-Indigo Naturalis Formula (RIF) for Treatment of Acute Promyelocytic Leukemia (APL) Sponsor: Xi'an Jiaotong University First Affiliated Hospital Principal Investigator: Wang Huaiyu Study Description: This multicenter, randomized controlled trial evaluates whether early induction treatment with oral Realgar-Indigo Naturalis Formula (RIF) combined with all-trans retinoic acid (ATRA) reduces early death rates in patients with acute promyelocytic leukemia (APL). APL is a subtype of acute myeloid leukemia characterized by a high risk of early death, largely due to coagulopathy and bleeding events, especially in high-risk patients with elevated white blood cell counts. Traditional treatment with ATRA and arsenic trioxide (ATO) has improved outcomes but early mortality remains a major challenge. RIF, an oral arsenic compound Chinese patent medicine, has demonstrated efficacy comparable to ATO with advantages in safety and oral administration convenience. Previous smaller studies suggested RIF may accelerate recovery of coagulation parameters and reduce early death. Patients clinically suspected of APL will be randomized into two groups: Experimental group: oral ATRA + RIF before molecular diagnosis confirmation Control group: oral ATRA only before confirmation After molecular or genetic diagnosis confirmation: Experimental group receives 1 week of ATRA + RIF induction (days 0-7), then switches to 3 weeks ATRA + ATO (days 8-28) Control group receives 4 weeks ATRA + ATO (days 0-28) Both groups then receive identical consolidation therapy with ATRA + ATO for 6 cycles (2 weeks treatment + 2 weeks off per cycle) following molecular complete remission. Primary Objective: To evaluate whether early induction with ATRA + RIF reduces early death rate (within 30 days of diagnosis) in APL patients. Secondary Objectives: To explore if early ATRA + RIF (prior to molecular confirmation) is non-inferior to ATRA alone in reducing coagulopathy and early death in suspected APL patients. Secondary endpoints include 2-year event-free survival (EFS) and overall survival (OS). Study Design: Type: Multicenter, randomized, open-label controlled clinical trial Population: Adults aged 18-80 years with newly diagnosed acute myeloid leukemia highly suspected as APL Randomization: Central randomization assigns participants to experimental (ATRA + RIF) or control (ATRA only) groups Blinding: Open-label (no blinding) Inclusion Criteria: Age 18-80 Newly diagnosed AML with strong clinical suspicion of APL based on bone marrow morphology and immunophenotyping Exclusion Criteria: Negative for PML-RARα fusion by cytogenetics or RT-PCR Severe organ dysfunction not related to APL (renal, hepatic, cardiac) QTc \>480 ms before treatment Other malignancies Pregnant or breastfeeding women Treatment Regimen: Induction: Experimental group receives oral ATRA 25 mg/m²/day + RIF 60 mg/kg/day for 7 days, then ATRA + intravenous ATO 0.15 mg/kg/day for 3 weeks; Control group receives ATRA + ATO for 4 weeks. Consolidation:During the consolidation phase, intermediate- and low-risk patients receive either intravenous ATO or oral RIF, while high-risk patients receive intravenous ATO together with intravenous mannitol infusion. Routine lumbar puncture and intrathecal chemotherapy are not performed. Supportive care includes hydroxyurea and venetoclax for elevated WBC, transfusions for coagulopathy, and dexamethasone for differentiation syndrome. Endpoints: Primary endpoint: Early death rate (death within 30 days of diagnosis) Secondary endpoints: 2-year event-free survival (EFS), 2-year overall survival (OS) Sample Size: Approximately 224 patients (112 per group), calculated to detect a reduction in early death rate from 12% (historical) to 3% (experimental), with 80% power and 5% significance level. Statistical Analysis: Descriptive statistics for baseline characteristics and adverse events Kaplan-Meier survival analysis for EFS and OS Significance threshold p \< 0.05 Safety Monitoring: Daily blood count and coagulation tests during induction Monitoring and management of adverse events including severe coagulation disorders, differentiation syndrome, arsenic toxicity, infection, and bone marrow suppression Adverse events graded with CTCAE criteria and reported accordingly Data Handling: Electronic data capture system compliant with ICH-GCP and CDISC standards Confidential storage at Xi'an Jiaotong University First Affiliated Hospital Data anonymized for reporting Ethics: Conducted in accordance with the Declaration of Helsinki and Chinese clinical research regulations Protocol approved by local ethics committee Written informed consent required before study enrollment Study Timeline: Planned start: June 2025 Planned completion: June 2028

This randomized, double-blind, placebo-controlled phase III clinical trial aims to evaluate the efficacy and safety of intravenous recombinant human Prourokinase (rhPro-UK) in acute ischemic stroke patients with large vessel occlusion presenting 4.5-24 hours after last known well. The study will address two primary questions: 1) Whether rhPro-UK enhances pre-thrombectomy reperfusion rates and improves 90-day functional outcomes compared to placebo; 2) Whether rhPro-UK increases the risk of symptomatic intracranial hemorrhage and mortality. Participants will be randomized to receive an intravenous bolus of rhPro-UK or matching placebo, with a total dose of 35mg (15mg administered as an intravenous push within 5 minutes, and the remaining 20mg continuously infused intravenously over 30 minutes). Key assessments include repeat neuroimaging (CT/CTA or MRI/MRA) at 24 hours post-treatment to evaluate reperfusion, NIH Stroke Scale score at day 5-7, and modified Rankin Scale score assessment at 90 days. Safety monitoring will focus on hemorrhagic transformation and mortality events throughout the study period.

Patent Foramen Ovale (PFO) is a common congenital heart defect. Recent studies have suggested a potential association between PFO and migraines, particularly migraine with aura. It is hypothesized that PFO may allow microemboli or vasoactive substances from venous blood to bypass pulmonary metabolism and enter the arterial system directly, potentially triggering migraines. Although PFO closure has been shown to reduce the frequency and severity of migraine attacks, its long-term efficacy and underlying mechanisms require further investigation. This study aims to explore the characteristics of glymphatic system function in PFO patients and its relationship with migraine symptoms, as well as the impact of PFO closure on glymphatic function and its role in alleviating migraine symptoms. A case-control and self-controlled before-after study design is adopted. Two groups of participants are enrolled: a case group consisting of PFO patients with significant right-to-left shunt and migraine, and a control group comprising PFO patients with significant shunt but without migraine. According to clinical guidelines and after obtaining informed consent, eligible patients in the case group undergo percutaneous PFO closure. By comparing migraine symptoms and glymphatic function indicators both before and after the procedure between the two groups, the interventional effect of PFO closure and its potential mechanism will be investigated. The primary endpoint is the improvement in migraine symptoms, while the secondary endpoints include glymphatic function metrics. The findings of this study will provide new theoretical insights and clinical guidance for the management of PFO-related migraines.

the existing anti-CMV drugs mainly include valganciclovir, ganciclovir and foscarnet sodium, all of which act on DNA polymerase (pUL54), making them prone to cross resistance. DNA synthesis in normal cell is also catalyzed by DNA polymerase, which can also inhibit normal cell production, especially in metabolically active bone marrow cells, leading to bone marrow suppression. In addition, these drugs are mainly metabolized by the kidneys, causing damage to proximal renal tubular cells. Therefore, it is necessary to closely monitor the patient's renal function and adjust the dosage. Overall, the medical demand for effective and well-tolerated treatment methods for CMV infection management in kidney transplant recipients remains unmet, and safer anti-CMV drugs are urgently needed. The target of letemovir is the CMV DNA terminal enzyme complex, which is different from the target of existing anti-CMV drugs, and does not exhibit cross resistance. Moreover, this target does not have a corresponding substance in mammalian cells and does not exhibit toxicity similar to DNA polymerase targets. In addition, letemovir is mainly metabolized by the liver, and urinary excretion can be ignored (\<2% dose), so there is no need to adjust the dose according to renal function. Phase III registered clinical studies abroad have shown that letemovir is not inferior to valganciclovir in preventing CMV disease in kidney transplant recipients. Additionally, letemovir is safer and has a lower incidence of adverse reactions, especially leukopenia or granulocytopenia. However, there is still a lack of data on the use of kidney transplantation in Chinese population. The aim of this study was to evaluate the efficacy and safety of letamovir in preventing CMV infection and CMV disease in kidney transplant recipients in China.

This is an open-lable, single arm, non-randomized study to evaluate the primary safety and efficacy of the novel bispecific AbTCR (anti-CD19/CD22)-T cells in patients with relapsed or refractory B-cell lymphoma

Large Artery Atherosclerosis is one of the most prevalent causes of stroke worldwide and is associated with a high risk of disability and recurrent strokes. Remote Ischemic Conditioning (RIC) is a promising therapy, and it has been recommended for further investigation in patients with acute ischemic stroke resulting from large artery atherosclerosis. The primary objective of this study is to assess the efficacy of RIC in patients suffering from acute moderate ischemic stroke due to large artery atherosclerosis.

Chronic hepatitis B can develop into cirrhosis and liver cancer, which seriously endangers the life and health of people. In China, HBV is mainly transmitted from mother to child, showing the phenomenon of family clusters. Similarly, cirrhosis and hepatocellular carcinoma occur in familial clusters. Familial clusters of HBV infection with unfavorable prognoses refers to HBV-infected patients from two consecutive generations of blood relatives, with at least one family member diagnosed with hepatitis B-related cirrhosis or hepatocellular carcinoma (HCC). Previous family investigations have shown that the risk and harm of HBV-related cirrhosis and hepatocellular carcinoma are significantly higher in families with familial clusters of HBV infection with unfavorable prognoses than in the general population. Currently, antiviral drugs used for CHB mainly include nucleoside analogues (NAs) and interferon-alpha (mainly pegylated interferon-alpha, Peg IFN). NAs mainly inhibits viral replication by blocking the reverse transcription process, but it cannot effectively inhibit the expression of viral proteins such as HBsAg, and rarely achieves clinical cure. Multiple clinical studies have shown that the use of NAs reduces the incidence of cirrhosis decompensation, HCC, and death in patients with CHB compared to untreated or placebo-treated patients. Despite long-term treatment with first-line NAs drugs, CHB patients continue to be at risk of developing hepatocellular carcinoma. Peg IFN α-2b injection is the first-line drug of choice for antiviral treatment of chronic hepatitis B, and its main mechanism of action includes anti-HBV, anti-fibrosis, anti-tumor and regulation of immune response. In 2024, a randomized controlled multicenter study showed that Peg IFN α-2b combined with NAs therapy could effectively prevent hepatocellular carcinoma in CHB patients. There is sufficient evidence in clinical practice that long-term antiviral therapy, whether NAs or Peg IFN α-2b, reduces the risk of cirrhosis, hepatocellular carcinoma, and death in patients with CHB. In conclusion, early antiviral therapy can reduce the risk of developing hepatitis B cirrhosis and hepatocellular carcinoma in CHB patients with familial clusters of HBV infection with unfavorable prognoses. The goal of this observational study is to explore the evaluation of pegylated interferon α-2b combined with first-line NAs on the long-term outcome of CHB antiviral therapy with cirrhosis and HCC progression as the main observation targets, compared with only use of NAs in the context of familial clusters of HBV infection with unfavorable prognoses. It is intended to provide high-quality evidence-based medical evidence for the treatment and follow-up of CHB, explore optimal clinical decision-making, and provide global clinical data for the improvement and evaluation of this difficult-to-treat population. The main question it aims to answer is: Can Peg IFN-α-2B combined with NAs therapy improve the long-term outcomes of this particular population of familial clusters of HBV infection with unfavorable prognoses compared to first-line NAs monotherapy? Patients with familial clusters of HBV infection with unfavorable prognoses using Peg IFN-α-2B combined with NAs therapy and NAs monotherapy will be collected laboratory and medical examination data at specified follow-up points, and recorded adverse events and drug combinations in detail for 7 years.

The objectives of this study are to improve HCV linkage-to-care in Chinese women and provide theoretical basis for the scientific formulation of HCV prevention and control strategies for pregnant women. To understand the epidemiological changes and status of hepatitis C virus (HCV) infection in pregnant women in Shaanxi province in recent 10 years, and to analyze the main influencing factors of hepatitis C infection in pregnant women.

This study aim to implement intraoperative hemodynamic monitoring and management guided with HPI algorithm in frail patients undergoing elective abdominal surgery. Investigators hypothesize that the use of this algorithm will alter treatment of hypotension and reduces the amount of hypotension as measured by the time weighted average (TWA) during non-cardiac surgery and to anticipate a reduction of postoperative AKI incidents, to explore the clinical benefits of impact of Acumen guided algorithm hemodynamic management in postoperative intestinal function recovery, and postoperative cardiac complications.

This multicenter, randomized controlled trial in China aims to enroll 2,400 patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI) within 24 hours post-fibrinolysis. Participants will be randomly assigned in a 1:1 ratio to receive either bivalirudin or heparin, with follow-up at 30 days and 1 year. The primary endpoint is a composite of all-cause mortality and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 30 days.

TBI, as a potential risk factor, causes a 1.5 times higher risk of neurodegenerative disease to up to 30-70% of TBI patients with neurological symptoms. Brain trauma is an important global medical, public health and social problem. Early diagnosis and effective treatment can effectively reduce the disability rate of patients and the incidence of neurological sequelae, and has increasingly become the focus of the international scientific research community. Exploring blood-based biomarkers has potential clinical value, which can greatly help clinicians to evaluate patients' conditions and develop reasonable plans, and then improve the clinical management and treatment of patients with craniocerebral trauma. Further research work is needed to be done to identify the most effective and efficient biomarker or combination marker strategies for integration into clinical treatment.

The goal of this clinical trial is to learn if abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS) works to treat autism spectrum disorder (ASD) in children. It will also learn about the safety of abdominal TEAS. The main questions it aims to answer are: Does abdominal TEAS a safe and effective treatment for children with autism spectrum disorder and gastrointestinal symptoms? Researchers will compare abdominal TEAS to a placebo (a sham abdominal TEAS without stimulation) to see if abdominal TEAS works to treat ASD. Participants will: Take abdominal TEAS or sham abdominal TEAS 5 days a week for 8 weeks. Visit the clinic once every 4 weeks for checkups and tests Keep a diary of their symptoms.

This is an early phase 1, open-label, single-center, dose-escalation, pilot trial to evaluate the safety and efficacy of an intravenous infusion of NGGT006 in homozygous familial hypercholesterolemia (HoFH) patients with LDLR mutations. NGGT006 is an adeno-associated viral (AAV) vector carrying codon-optimized human LDLR gene, driving the expression of LDLR protein with normal function and promoting the clearance of low-density lipoprotein cholesterol (LDL-C).

The goal of this clinical trial is to learn if traditional pancreaticoduodenectomy (PD) combined with TRIANGLE (extended PD surgery) can increase disease-free survival (DFS) in patients with pancreatic head cancers compared to traditional minimally invasive PD. The main questions it aims to answer are: * Does extended PD surgery increase disease-free survival (DFS)? * Does extended PD surgery could improve postoperative and long-term quality of life for patients? Researchers will compare extended PD surgery to traditional PD surgery to see if extended PD surgery could extend the survival time of patients. Participants will: * Accept traditional minimally invasive PD surgery or minimally invasive PD combined with TRIANGLE surgery. * Visit the clinic once every 3 months for checkups and tests. * Keep a diary of their symptoms.

The goal of this study is to determin the MRI features associated with cerebral palsy and to develop prediction models of pediatric disorders by combining MRI with artificial intelligence. The main questions it aims to answer are: * How to achieve features on conventional MRI associated with cerebral palsy? * How to predict the risk of cerebral palsy in infants aged 6 to 2 years based on conventional MRI and deep learning? Researchers will compare characteristics of periventricular white matter injury with cerebral palsy to those without cerebral palsy. Participants will be asked to provide MRI data, clinical diagnoses information, and follow-up outcomes.

The IVUS-CKD study is a prospective, randomized controlled, multicenter trial to determine whether the intravascular ultrasound (IVUS)-guided percutaneous coronary intervention is superior to the angiography-guidance in chronic kidney disease (CKD) patients with respect to target vessel failure (TVF) at 12 months after randomization.

This study intends to retrospectively-prospectively enroll NVM patients from multiple centers to establish a natural population cohort of NVM patients. By collecting clinical data and biological samples from surgical patients, the investigators will construct a prognosis prediction system for NVM, optimize risk stratification, explore new strategies for the early prevention and treatment of NVM, and improve the efficiency of clinical treatment of NVM patients.

This study is a single-arm, single-center, exploratory clinical study. It is expected that 44 patients with advanced gastric and gastroesophageal junction adenocarcinoma with first-line treatment failure will be included to receive irinotecan liposomes combined with cindilizumab and renvalatinib. The study unit is the First Affiliated Hospital of Xi'an Jiaotong University. The study included screening period (28 days), treatment period (6 cycles), and follow-up period. Subjects signed the informed consent and underwent baseline examination during the screening period, patients meeting the exclusion criteria entered the treatment period, and all subjects completed the protocol to observe safety, tolerability and efficacy. The same subject received only one dosing schedule during the study period. The follow-up period begins after the end of the treatment period.