Clinical trials

An Open-Label, Single-Arm, Multicenter Phase II Clinical Study to Evaluate the Efficacy of Azacitidine, Chidamide, and PD-1 Monoclonal Antibody in the Treatment of Refractory/Relapsed Peripheral T-Cell Lymphoma.

The goal of this clinical trial is to evaluate the effectiveness of PRaG-1 in improving CD8+ lymphocytopenia in patients with solid tumors who are tumor-free for more than six months after completing radiotherapy and/or chemotherapy. It will also assess the safety of PRaG-1 Cordycepin in these patients. The main questions it aims to answer are: Does PRaG-1 increase CD8+ lymphocyte counts by more than 25% in this patient population? Does the effect of PRaG-1 maintain when treatment is discontinued? What are the safety and tolerability profiles of PRaG-1 during and after the treatment period? Participants will receive open-label PRaG-1 (one tablet in the morning and one in the evening) for 14 days, and those who show a response (CD8+ lymphocytes increase by more than 25%) will enter a 14-day randomized withdrawal period, where they will be assigned to continue PRaG-1 or switch to a placebo. Throughout the study, participants will: Have their peripheral blood lymphocyte subpopulations tested at baseline and on Days 7 and 14 Undergo safety monitoring for adverse events according to CTCAE 5.0 criteria Provide information on their quality of life during the treatment period Researchers will compare the outcomes of those who continue PRaG-1 to those who receive a placebo to determine if the observed improvement in CD8+ lymphocytes is sustained, which would indicate that the drug is effective in maintaining immune response.

This study is a single-arm, multi-center, prospective clinical study aimed at exploring the efficacy and safety of cetuximab β combined with PRaG regimen in rescuing patients with EGFR-positive advanced refractory solid tumors.

The goal of this clinical trial is to learn if a combination treatment using PRaG-1 Cordycepin Tablets with radiation therapy, immune-boosting injections, and immunotherapy drugs can help patients with advanced solid tumors. It will also assess safety. The main questions it aims to answer are: Does this treatment improve immune function and slow tumor growth? What side effects or risks occur during treatment? Participants will: Take PRaG-1 Cordycepin Tablets (a natural compound derived from Cordyceps fungus) orally: higher dose for 7 days before radiation, then lower daily dose for 2 weeks Receive targeted radiation therapy to the tumor area (5-12 Gy total in 2-3 sessions) Get daily immune-boosting injections (GM-CSF) for 7 days starting with radiation Receive immunotherapy drugs (PD-1/PD-L1 inhibitors) within one week after radiation Have blood drawn and small tumor tissue samples taken before and after the first two treatment cycles for immune analysis All participants will receive this combination treatment; there is no placebo or alternative treatment group in this study.

Post-stroke cognitive impairment (PSCI) increases the risk of disability and mortality in stroke patients, thereby exacerbating the disease burden of stroke. Type 2 diabetes is a major risk factor for PSCI, and stroke patients with type 2 diabetes have a higher risk of developing PSCI. Despite the high incidence and severe impact of PSCI, effective intervention methods are still lacking. Identifying safe and effective drugs to improve cognitive function in stroke patients and reduce the risk of PSCI, especially for those with type 2 diabetes, is of significant importance and could help reduce the burden of stroke. Dipeptidyl peptidase-4 (DPP4) inhibitors are first-line antidiabetic drugs, and several studies have shown that DPP4 inhibitors provide benefits beyond glucose control, including significantly improving cognitive function in patients with type 2 diabetes or slowing the progression of cognitive impairment. Our previous research found a significant negative correlation between baseline plasma soluble DPP4 (sDPP4) levels and the 90-day PSCI risk in ischemic stroke patients. Moreover, some studies indicate that DPP4 inhibitors can increase plasma sDPP4 levels. Based on this, we hypothesize that DPP4 inhibitors could be effective for PSCI intervention and may improve cognitive function post-stroke. This project aims to conduct a multicenter, randomized, double-blind, placebo-controlled study. We will include patients with mild ischemic stroke combined with type 2 diabetes and provide continuous intervention with DPP4 inhibitors or a placebo for 180 days. Cognitive function in both groups will be assessed before and after intervention to determine if DPP4 inhibitors can improve cognitive function and reduce the risk of PSCI in ischemic stroke patients with type 2 diabetes. Clinical blood samples and imaging data will also be used to preliminarily explore potential mechanisms.

This study aims to evaluate whether initiating intravenous tirofiban within 48 hours of onset (with a 48-hour infusion), followed by sequential DAPT, can improve the likelihood of excellent functional outcomes (modified Rankin Scale score 0-1) in mild stroke patients, compared with standard DAPT therapy based on current guidelines.

The study is a single-center, prospective, single-arm, Phase II clinical trial. Eligible patients with advanced solid malignant tumors will sign the informed consent form and undergo screening for enrollment. After enrollment, patients will receive oral administration of "PRaG-1" twice daily (morning and evening) for a total of 10 days. Peripheral blood lymphocyte tests will be performed before treatment, on day 5 post-treatment, and at the conclusion of treatment.

This phase II clinical trial is designed to evaluate a novel combination treatment for patients with newly diagnosed central nervous system lymphoma (CNSL) who are not candidates for stem cell transplantation. The study will assess the safety and effectiveness of combining selinexor (an oral selective nuclear export inhibitor) with high-dose methotrexate and rituximab chemotherapy, followed by low-dose whole-brain radiotherapy (WBRT). Selinexor has shown promise in enhancing the effects of chemotherapy and radiation in blood cancers. Patients enrolled in this open-label, single-arm, multicenter study will receive up to six 21-day treatment cycles. Those who respond well will undergo reduced-dose WBRT and continue selinexor as maintenance therapy. The study will measure how many patients respond to the treatment (overall response rate), how long the response lasts (progression-free survival), overall survival, and safety. This research aims to provide a less toxic and more effective option for treating CNSL in patients who are older or medically unfit for transplantation.

Research Objectives To evaluate the impact of finerenone on renal function, diabetic complications, and safety in patients with Type 2 diabetes and chronic kidney disease. Study Design Type: Prospective, single-arm, multicenter clinical trial. Sample Size: 300 patients. Intervention: Finerenone added to existing treatment regimen (10-20 mg once daily, dose adjusted based on eGFR), for 48 weeks. Data Collection Time Points: Baseline, 4 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks. Primary Endpoint: Change in urine albumin-to-creatinine ratio (UACR). Secondary Endpoints: Changes in eGFR, 24-hour urine protein, serum uric acid, retinopathy markers, pulse wave velocity (PWV), ankle-brachial index (ABI), etc. Safety Endpoints: Changes in serum potassium, sodium, and blood pressure.

Carry out precise and effective neuromodulation interventions, and develop new neuromodulation technologies for sleep disorders. Use phototherapy, transcranial electrical/magnetic stimulation and other therapies to conduct self-controlled intervention studies on insomnia, narcolepsy, and rapid eye movement sleep behavior disorder .

The aim of this randomized controlled trial (RCT) is to clarify the effect of bright light therapy on motor symptoms and sleep disorders in patients with Parkinson's disease.

Thoracic surgery is widely recognized as one of the most painful surgical procedures. Compared to open thoracotomy, video-assisted thoracoscopic surgery (VATS) offers similar therapeutic outcomes with less invasiveness, significantly reducing postoperative pain and promoting recovery. Despite the use of video-assisted thoracoscopic surgery (VATS), a significant proportion of patients still experience considerable discomfort. Specifically, 78% of patients report moderate to severe pain, with 27% experiencing moderate pain, 34% severe pain, and 17% very severe pain. Multiple studies have shown that the use of regional anesthesia, such as thoracic paravertebral nerve block (TPVB), in these surgeries can block the transmission of nociceptive signals via the intercostal nerves, producing good analgesic effects. This can reduce the consumption of postoperative opioids, decrease inflammatory responses, and improve patient survival rates after surgery. By comparing the differences in hemodynamic parameters, inflammatory stress indicators, and intraoperative and postoperative analgesic effects of thoracic paravertebral nerve block in different preoperative positions for patients undergoing thoracoscopic surgery, we aim to identify the optimal nerve block position, thereby promoting patient recovery.

Atrial fibrillation (AF) is the most common sustained arrhythmia in clinical practice, significantly increasing the risks of death, stroke, heart failure, cognitive impairment, and dementia, thus severely impacting patients' quality of life. However, for AF patients with concomitant cardiovascular risk factors, particularly those with obstructive sleep apnea (OSA), the success rate of catheter ablation is significantly reduced. Continuous positive airway pressure (CPAP) is currently an effective treatment for OSA, effectively correcting nocturnal intermittent hypoxia and fragmented sleep caused by OSA. However, the effect of CPAP therapy on AF recurrence in patients with OSA undergoing catheter ablation remains controversial. Faced with conflicting research findings, our team recently conducted a meta-analysis (registration number CRD42023398588) to assess the impact of CPAP on AF recurrence post catheter ablation in patients with AF and OSA, suggesting that CPAP significantly reduces AF recurrence post catheter ablation (RR = 0.58, P \< 0.01). However, considering the limited number of included studies, potential bias risks, and confounding factors, our meta-analysis results await further confirmation through real-world studies by our team. Therefore, our team plans to conduct further research on the impact of CPAP on AF recurrence post catheter ablation in patients with moderate to severe OSA, aiming to provide clinical guidance for the treatment of AF in patients with moderate to severe OSA.

The goal of this clinical trial is to learn about Phase I+Phase II Clinical Study of PRaG Therapy in Combination With Chemotherapy (AG Regimen) for Neoadjuvant Treatment of Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (NeoPRAG Study).The main question it aims to answer is to investigate the safety and efficacy of the PRaG treatment modality combined with chemotherapy neoadjuvant therapy for locally advanced pancreatic cancer.

A prospective, single center, randomized, clinical controlled study to evaluate the efficacy and prognosis differences between precision treatment based on plasma cfDNA testing results and the current conventional diagnostic and treatment practices for DLBCL patients.

Elderly patients with advanced triple-positive breast cancer have the characteristics of low physical status and poor treatment tolerance. Therefore, such patients are often unable to tolerate more toxic chemotherapy regimen, and it is particularly important to choose a highly effective and low-toxic treatment regimen. However, few studies have paid attention to the treatment of such patients in the past. Pyrrotinib is a small molecule, irreversible, panerbb receptor tyrosine kinase inhibitor, which was independently developed by our country and has shown excellent efficacy in second-line anti-HER2 treatment of breast cancer, and has become the second-line standard treatment choice for advanced HER2-positive breast cancer. In addition, PHILA study results showed that the mPFS of pyrrotinib group reached 24 months. Compared with the control group, the duration of 10 months was significantly extended, indicating the significant efficacy of pyrrotinib in the first-line treatment of advanced HER2-positive breast cancer. Darsili is a CDK4/6 inhibitor independently developed in China, which has been reconstructed and optimized in molecular structure, and has become a new CDK4/6 inhibitor with more powerful modification by introducing piperidine structure through replacement of classical electronic and other panbody. The results of DAWNA-2 study indicated that the mPFS of Dalsily combined AI group reached 30.6 months, which was significantly longer than 18.2 months of the control group, and was the longest in similar studies. MUKDEN01 study, for the first time, tried the efficacy of pyrrotinib + letrozole + Dalsily regimen in the new adjuvant therapy of TPBC patients, and the results showed that ORR reached 87.4%, CR rate was 30.4%, and pCR rate was 35.4%. Therefore, to further confirm the efficacy and safety of this protocol in elderly patients with advanced triple positive breast cancer, we intend to conduct this study. This is a prospective, single-arm, single-center clinical trial in which participants were treated with darcilide +AI (letrozole/anastrozole/exemestane) + pyrrotinib until disease progression, toxicity became intolerable, informed consent was withdrawn, or investigator judgment required discontinuation. The successful development of this study provides a new direction for the first-line treatment of elderly advanced triple-positive breast cancer.

The purpose of this study is to evaluate the efficacy and electrophysiology of repetitive transcranial magnetic stimulation in the treatment of essential tremor.

This is an open-label, single-arm, Phase II investigator-initiated trial of hypofractionated radiotherapy combined with PD-L1 inhibitor sequential GM-CSF and thymopentin for treatment of elderly patients with advanced solid tumors, when the HER-2 positive patients are treated with extra antibody-drug conjugate.