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NCT ID: NCT06044207 Recruiting - Clinical trials for Perioperative Neurocognitive Dysfunction

Biomarkers and Risk Factors for Perioperative Neurocognitive Dysfunction in Elderly Patients

Start date: June 1, 2023
Phase:
Study type: Observational

Basic information and biological samples of patients were collected preoperatively and intraoperatively, and patients were divided into case and control groups by cognitive function assessment postoperatively, and risk factors and biomarkers of perioperative cognitive dysfunction were derived by analyzing and statistically processing basic information and biological samples.

NCT ID: NCT06044077 Recruiting - Clinical trials for Pneumococcal Disease

A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People

Start date: September 8, 2023
Phase: Phase 3
Study type: Interventional

This study is a randomized, blinded, parallel controlled phase 3 clinical trial to evaluate the immunogenicity and safety of the 23-valent pneumococcal polysaccharide vaccine in healthy people aged 2 years and above.

NCT ID: NCT06043999 Recruiting - Rectal Cancer Clinical Trials

Salvage Chemotherapy Versus Total Mesorectal Resection for Local Resection Rectal Cancer Patients

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Whether to perform radical TME or salvage chemoradiotherapy after local resection of intermediate-risk T1 rectal cancer is still controversial. A study based on the National Cancer Data Center showed that, because of the need for organ preservation, rescue chemoradiotherapy after local resection of rectal cancer was used in 10% of patients with T1N0 tumors and in 40% of patients with T2N0 tumors. However, the local recurrence caused by non-TME surgery is still the focus of concern for clinicians and patients. Previous retrospective studies have shown that there is no significant difference in overall survival and disease free survival between salvage CRT group and salvage TME group for patients with early rectal cancer after local resection. Pathological pT2 after local resection is the only independent risk factor for disease-free survival. However, limited to a single center and small sample size, the recurrence caused by salvage radiotherapy and chemotherapy should still be alert. Given these concerns, there is an urgent need to identify a better treatment regimen that can ensure reliable oncologic outcomes after local resection. Therefore, with TME as the control group and salvage chemoradiotherapy as the experimental group, we conducted a prospective, randomized, multicenter, non-inferiority clinical trial of the treatment effect of patients with intermediate-risk T1 and clinical stage N0M0 rectal cancer after local resection, to provide high-level evidence-based medical evidence for the final choice of these two salvage treatment methods.

NCT ID: NCT06043973 Recruiting - Clinical trials for Advanced Non-small Cell Lung Cancer

Almonertinib Combined With Anlotinib as First-line Treatment for Advanced Non-small Cell Lung Cance

Start date: September 1, 2023
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of almonertinib plus anlotinib as first-line treatment for advanced non-small cell lung cancer with EGFR sensitive mutation and TP53 mutation. This study is an exploratory single-arm study. The specific treatment regimen is as follows: Non-squamous NSCLC: almonertinib (110 mg/d) plus anlotinib (12mg/d) is started on the first day of each treatment cycle and administered every three weeks until disease progression or intolerable toxicity. Anlotinib was given for two weeks, followed by one week off. Patients are assessed for measurable disease at baseline, 6 weeks, 12 weeks after starting treatment, and every 9 weeks thereafter according to RECIST 1.1 criteria during the treatment period until disease progression or intolerable toxicity withdrawal. Following discontinuation of treatment, subjects are followed for survival status every 3 months until death. Subject safety was assessed during treatment according to NCI CTCAE Version 4.0 criteria. Subjects who experience an AE should be followed until the AE returns to baseline. The primary endpoints is Progression-free survival (PFS) . Secondary endpoints include objective response rate (ORR), overall survival (OS) and safety (NCI CTCAE v 4.0). Statistical methods: The PFS curve was estimated using the Kaplan-Meier method for the largest population to be analyzed. The confidence interval method was used as the criterion for the main analysis. OS was calculated in the same way as the secondary endpoint. Descriptive statistics will be used to analyze ORR, DCR, etc. It is expected that almonertinib plus anlotinib as first-line treatment will prolong median PFS and OS of advanced non-small cell lung cancer with EGFR sensitive mutation and TP53 mutation patients.

NCT ID: NCT06043908 Recruiting - Dry Eye Clinical Trials

The Effect of 0.05% CsA Eye Drops on Post-refractive Surgery Dry Eye

Start date: August 31, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this study is to observe the effect of 0.05% cyclosporine eyedrops combined with artificial tears in patients with dry eyes after corneal refractive surgery and to observe the changes in ocular surface characteristics and tear inflammatory cytokines before and after treatment.

NCT ID: NCT06043466 Recruiting - Breast Cancer Clinical Trials

A Clinical Trial Targeting CEA Chimeric Antigen Receptor T (CAR-T) for CEA Positive Advanced Malignant Solid Tumors

Start date: August 11, 2023
Phase: Phase 1
Study type: Interventional

This is a single-arm, open, dose-increasing phase I clinical study to explore the safety, tolerability and pharmacokinetic characteristics of the drug C-13-60 cells, and preliminarily observe the efficacy of the drug in CEA positive late malignant solid tumors, and explore the applicable dose regimen for phase II clinical trials.

NCT ID: NCT06043232 Recruiting - Glioma Clinical Trials

MMR/MSI Phenotypes in Prediction of Tumor Vaccine Benefit for Gliomas

Start date: September 2023
Phase:
Study type: Observational

Glioblastoma (GBM) is the most malignant primary intracranial tumor with a median survival of about 18 months, and new therapies are urgently needed. Tumor vaccines has been shown to improve survival of GBM, but not all patients can benefit from vaccine treatment and biomarkers are urgently needed. Deletion of mismatch repair (MMR) protein and microsatellite instability (MSI) state are important features in the biological evolution of GBM, and may be used as markers for tumor vaccine. Therefore, this project will collect samples from GBM patients before and after vaccine treatment respectively, and evaluate the role of MMR/MSI gene phenotype in predicting vaccine efficacy and the potential molecular mechanism. Moreover, MMR/MSI phenotypes will be assessed by deep-learning and radiomics using images to establish noninvasive markers for vaccine.

NCT ID: NCT06042998 Recruiting - Clinical trials for Gastric Cancer Stage III

A Multicenter, RCT Study of the Clinical Efficacy of Robotic and Laparoscopic Gastrectomy in Neoadjuvant Gastric Cancer

CLASS14
Start date: July 7, 2023
Phase: N/A
Study type: Interventional

To evaluate the clinical efficacy of robot radical Gastrectomy and laparoscopic radical Gastrectomy, patients with gastric adenocarcinoma (cT2N+M0 or cT3-4a/N+M0, phase II and III) undergoing neoadjuvant treatment were selected as subjects.

NCT ID: NCT06042894 Recruiting - Breast Cancer Clinical Trials

A Study of SI-B003 or BL-B01D1+SI-B003 in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer

Start date: December 12, 2023
Phase: Phase 2
Study type: Interventional

This phase II study is a clinical study to explore the efficacy and safety of SI-B003 monotherapy and BL-B01D1+SI-B003 combination therapy in patients with unresectable locally advanced or recurrent metastatic HER-2 negative breast cancer.

NCT ID: NCT06042764 Recruiting - Clinical trials for Infection of Upper Respiratory Tract Caused by 2019-nCoV

SA55 Injection Phase II Study in the Treatment of Mild/Moderate COVID-19 Patients

Start date: August 31, 2023
Phase: Phase 2
Study type: Interventional

Evaluating the efficacy and safety of SA55 injection in light/medium COVID-19 patients