Clinical trials: sponsored by Changhai Hospital
Autoimmune Diseases, Systemic Lupus Erythematosus
Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA U CAR T cells in patients with autoimmune diseases. 60 patients are planned to be enrolled in the dose-escalation trial.
- Conditions
- Autoimmune Diseases, Systemic Lupus Erythematosus, Systemic Sclerosis, Primary Sjögren Syndrome
- Trial name
- NCT07246096
- Testing
- anti-CD19/BCMA U CAR T cells
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Changhai Hospital
Pancreatic Cancer
CAR-NK Cells (CL-NK-003) in Pancreatic Cancer
This is a single-center, open-label, first-in-human, fixed-dose study in patients with pancreatic cancer.
- Trial name
- NCT07425483
- Testing
- CL-NK-003
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Changhai Hospital
Relapsed/Refractory Immune Nephropathy, Relapsed/Refractory Immune-mediated Kidney Disease
An Exploratory Clinical Study on the Safety and Efficacy of Anti-CD19/BCMA U CAR-T Cells in the Treatment of Relapsed/Refractory Immune-mediated Kidney Disease
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA U CAR T cell injection (KN3601) in patients with Relapsed/Refractory immune-mediated kidney disease
- Trial name
- NCT07241468
- Testing
- anti-CD19/BCMA U CAR T
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Changhai Hospital
Neoadjuvant Chemoradiation Therapy, Rectal Cancer
Neoadjuvant Chemoradiation Therapy Combined With Immunotherapy for MSS Ultra-low Rectal Cancer
At present, there are no relevant studies or reports on the effect of neoadjuvant chemoradiation therapy combined with immunotherapy for MSS ultra-low rectal cancer.
- Conditions
- Neoadjuvant Chemoradiation Therapy, Rectal Cancer, Immunotherapy, Microsatellite Instability Low
- Trial name
- NCT05215379
- Testing
- xintilimab injection, Control
- Where
- China
- Volunteers
- 201 people
- Sponsor
- Changhai Hospital
Postoperative Pain, Video-assisted Thoracoscopic Surgery (VATS)
Effect of Transcutaneous Electrical Nerve Stimulation Based on Wrist-ankle Acupuncture Theory on Postoperative Pain After Video-assisted Thoracoscopic Surgery
At present, surgical resection remains one of the main methods for the radical treatment of lung cancer. Compared with traditional thoracotomy, Video-assisted Thoracoscopic Surgery (VATS) offers obvious advantages, such as less…
- Trial name
- NCT06744166
- Testing
- TENS-WAA
- Where
- China
- Volunteers
- 156 people
- Sponsor
- Changhai Hospital
Pancreatic Cancer, Pancreatic Neoplasms
Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Pancreatic Cancer
This clinical trial will evaluate the safety and activity of mutant KRAS G12V-specific TCR transduced T cell therapy for advanced pancreatic cancer patients who express the KRAS G12V mutation and HLA-A*11:01 allele.
- Conditions
- Pancreatic Cancer, Pancreatic Neoplasms, Pancreatic Ductal Adenocarcinoma, Advanced Cancer
- Trial name
- NCT04146298
- Testing
- Cyclophosphamide, Fludarabine, Mutant KRAS G12V-specific TCR transduced autologous T cells
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Changhai Hospital
Lumbar Spinal Stenosis (LSS), Degenerative Spondylolisthesis G1
Multicenter Clinical Randomized Controlled Trial of Unilateral Biportal Endoscopic Spinal Surgery for Degenerative Grade 1 Spondylolisthesis Complicated With Lumbar Spinal Stenosis
The research objective of this project is to clarify and compare the efficacy of the unilateral biportal endoscopy (UBE) technique and traditional open decompression, fusion and internal fixation surgery in the treatment of…
- Trial name
- NCT07303348
- Testing
- UBE, PLIF
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Changhai Hospital
IgG4 Related Disease
An Exploratory Clinical Study on the Safety and Efficacy of CD19/BCMA CAR-NK in the Treatment of Relapsed and Refractory IgG4-related Disease
A single arm, open-label pilot study is designed to determine the safety and effectiveness of CD19/BCMA CAR NK cells (KN5601) in patients with IgG4 related diseases.
- Trial name
- NCT07298590
- Testing
- CD19/BCMA CAR NK
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Changhai Hospital
Perioperative Analgesia, General Anaesthesia
Effect of Transcutaneous Electrical Nerve Stimulation Based on Wrist-ankle Acupuncture Theory on EC50 of Remifentanil Inhibiting Responses to Tracheal Intubation Under General Anesthesia
During endotracheal tube insertion under general anesthesia, sympathetic nerve activity increases, which leads to increased heart rate, increased blood pressure, and increased catecholamine levels in the blood.
- Trial name
- NCT06748898
- Testing
- TENS-WAA, non TENS-WAA
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Changhai Hospital
Gastric Cancer, Gastric High-grade Intraepithelial Neoplasia
Establishment and Effectiveness Evaluation of a Training System for Confocal Laser Endomicroscopy
Gastrointestinal endoscopy is a vital method for screening and diagnosing gastric cancer. It aids in identifying the tumor's location within the stomach and its macroscopic type, and allows biopsy for histological confirmation.
- Conditions
- Gastric Cancer, Gastric High-grade Intraepithelial Neoplasia, Gastric Low-grade Intraepithelial Neoplasia, Gastritis
- Trial name
- NCT06981819
- Testing
- Probe-based Confocal Laser Endomicroscopy by Experts, magnifying endoscopy with blue laser imaging, Probe-based Confocal Laser Endomicroscopy by trainees
- Where
- China
- Volunteers
- 147 people
- Sponsor
- Changhai Hospital
Treatment
Different Patterns of Target Delineation in SBRT for Locally Advanced Pancreatic Cancer
The purpose of this study is to compare the efficacy and safety of a recurrence-pattern-based-volume versus conventional-volume stereotactic body radiation therapy for locally advanced pancreatic cancer, so as to determine…
- Trial name
- NCT04699539
- Testing
- SBRT, Chemotherapy
- Where
- China
- Volunteers
- 96 people
- Sponsor
- Changhai Hospital
Pancreatitis, Chronic
Optimal Timing of Endoscopic Intervention in the Treatment of Chronic Pancreatitis.
This study aims to determine the optimal timing of endoscopic intervention after extracorporeal shock wave lithotripsy(ESWL) of chronic pancreatitis with pancreatic stones.
- Trial name
- TEST (NCT05270434)
- Testing
- time interval between ESWL and ERCP is 12h, time interval between ESWL and ERCP is greater than 12h, morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid (Analgesics)
- Where
- China
- Volunteers
- 220 people
- Sponsor
- Changhai Hospital
Post-ERCP Pancreatitis
Low-Dose vs Standard-Dose Indomethacin for Preventing Post-ERCP Pancreatitis
Endoscopic Retrograde Cholangiopancreatography (ERCP) is a widely used procedure for diagnosing and treating pancreatic and biliary diseases.
- Trial name
- NCT07088757
- Testing
- standard dose indomethacin, low dose indomethacin
- Where
- 12 sites in China
- Volunteers
- 1,366 people
- Sponsor
- Changhai Hospital
Treatment
Stereotactic Radiotherapy in Locally Advanced Pancreatic Cancer With Different Biological Effective Doses
The aim of this study is to compare the safety and efficacy of SBRT in LAPC with different biological effective dose (BED) (<70Gy Vs.>70Gy ) , to identify a dose range that could achieve better survival benefit and minimize the…
- Trial name
- NCT04603586
- Testing
- SBRT, Chemotherapy
- Where
- 2 sites in China
- Volunteers
- 119 people
- Sponsor
- Changhai Hospital
Bladder Cancer
Investigation Into the Integration of Intracavitary Cryoablation and Immunotherapy in Bladder-Preserving Therapy
Professional Translation: This study is a single-center, prospective, non-randomized, parallel-controlled clinical trial initiated and conducted by the Department of Urology at the First Affiliated Hospital of Naval Medical…
- Trial name
- NCT07204132
- Testing
- TURBT combined with cryoablation-assisted postoperative immunotherapy, The conventional surgery treatment group
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Changhai Hospital
Chronic Pancreatitis, Pancreatic Neoplasm
Prediction Model of Pancreatic Neoplasms in CP Patients With Focal Pancreatic Lesions
This study aims to develop XGBoost machine learning model to predict pancreatic neoplasms in CP patients with focal pancreatic lesions.
- Conditions
- Chronic Pancreatitis, Pancreatic Neoplasm, Machine Learning
- Trial name
- NCT07045181
- Testing
- XGBoost machine learning
- Where
- China
- Volunteers
- 113 people
- Sponsor
- Changhai Hospital
Paroxysmal Atrial Fibrillation, Paroxysmal Atrial Fibrillation (PAF)
Pulsed Field Ablation of SVC and PV in Paroxysmal Atrial Fibrillation (PASPA Study)
The PASPA study is a multicenter, randomized trial comparing Pulmonary Vein Isolation (PVI) alone versus PVI plus Superior Vena Cava Isolation (SVCI) using Pulsed Field Ablation (PFA) in patients with paroxysmal atrial…
- Trial name
- PASPA (NCT07191626)
- Testing
- PFA - PV + SVCI, PFA - PVI only
- Where
- China
- Volunteers
- 650 people
- Sponsor
- Changhai Hospital
Pancreatic Cancer, Pancreatitis
Pancreatic Disease Burden in Older Adults (1990-2040)
Using data from the Global Burden of Disease Study 2021, the investigators analyzed age-standardized incidence, mortality, and disability-adjusted life-years (DALYs) for pancreatic cancer and pancreatitis in adults aged ≥70 years…
- Trial name
- NCT07177599
- Testing
- Natural history
- Volunteers
- 723,415 people
- Sponsor
- Changhai Hospital
Bowel Preparation for Colonoscopy
Efficacy of Low-residue Full Nutritive Formula Powder in Bowel Preparation for Colonoscopy
Previously, our team compared the effects of a low-residue full nutrition formula podwer (FNFP) combined with 3 liters of polyethylene glycol(PEG) solution and the self-prepared low-residue diet combined with 3 liters of PEG…
- Trial name
- NCT06514989
- Testing
- Low-residue full nutrition formula podwer, Self-prepared low-residue diet
- Where
- 27 sites in China
- Volunteers
- 757 people, healthy volunteers welcome
- Sponsor
- Changhai Hospital
Gastric Outlet Obstruction
Novel Balloon-Assisted vs Direct Technique in EUS-Guided Gastroenterostomy
Gastric outlet obstruction (GOO) refers to mechanical blockage at the pylorus or duodenum, most commonly caused by unresectable malignancies of the stomach, duodenum, or pancreas.
- Trial name
- NCT07161856
- Testing
- a novel balloon-assisted EUS-GE, direct EUS-GE
- Volunteers
- 272 people
- Sponsor
- Changhai Hospital