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NCT ID: NCT04909307 Recruiting - Surgery Clinical Trials

Surveillance of Association of Immune Status and Prognosis of CNS Germ Cell Tumor Survivors

Start date: June 1, 2019
Phase:
Study type: Observational [Patient Registry]

Platinum-based chemotherapy, alternating at 21-days intervals with cycles of ifosfamide, cisplatin, and etoposide (ICE) and subsequently received radiotherapy were considered as standard treatment for intracranial germ cell tumors. However, whether reliable clinical data can quantify the damage degree of immunologic function caused by chemotherapy and radiotherapy is still unknown. This project regards the level of lymphocyte and immunocyte in peripheral blood as a quantitative index to reflect the dynamic change of the immunologic function of patients with CNS germ cell tumors before and after chemoradiotherapy treatment. Meanwhile, the investigators will also investigate the relationship between the level of lymphocyte and immunocyte in peripheral blood and the response rate of therapy.This study is designed to prospectively analyze the dynamic changes of immune status, prognosis and society function after standard treatment in patients with intracranial germ cell tumor.

NCT ID: NCT04908865 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Open-label Study of Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Active Systemic Lupus Erythematosus (SLE)

Start date: October 21, 2021
Phase: Phase 4
Study type: Interventional

This study will be conducted to evaluate the safety, efficacy and pharmacokinetics of belimumab administered in combination with background standard therapy in pediatric participants with active SLE.

NCT ID: NCT04908696 Recruiting - Glottic Carcinoma Clinical Trials

Clinical Treatments in Specialized Disease of Laryngeal Carcinoma (LC) and Hypopharyngeal Carcinoma (HPC)

Start date: December 1, 2020
Phase:
Study type: Observational

For early stage laryngeal carcinoma and hypohparyngeal carcinoma (T1 and T2), transoral laser microsurgery, open partial laryngectomy, radiotherapy, and transoral robotic surgery were performed according to NCCN guidelines (2020). For advanced stage laryngeal carcinoma and hypohparyngeal carcinoma (T3 and T4), surgical treatment ± postoperative adjuvant therapy, chemoradiotherapy, neoadjuvant therapy + radiotherapy/chemoradiotherapy, or neoadjuvant therapy + surgery + radiotherapy or chemoradiotherapy performed according to NCCN guidelines (2020). This study plan to analyze the clinical ouctomes of different treatment for the same T stage disease. The overall survival rate, disease specific survival, disease free survival, local control, regional control, and laryngeal function preservation rate were analyzed in this study.

NCT ID: NCT04908566 Recruiting - Clinical trials for Locally Advanced Gastric Adenocarcinoma

Immune Checkpoint Inhibitor PD-1 Antibody Combined With Chemotherapy in the Perioperative Treatment of Locally Advanced Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

Start date: May 2021
Phase: Phase 2
Study type: Interventional

The FOLFIRINOX regimen has become the standard treatment regimen for advanced colorectal cancer, advanced pancreatic cancer and postoperative adjuvant treatment for pancreatic cancer. With the continuous exploration of Chinese scholars, it has also revised the modified dose suitable for the physical fitness of the Chinese people, which is well tolerated and has a clear efficiency. The drugs in this program are all standard treatment drugs for gastric cancer. In 2020, JAMA Network Open and JAMA Oncology successively reported the application of FOLFIRINOX in the perioperative period of gastric cancer and the late-stage results of gastric cancer, and they obtained very amazing data respectively. According to the results of CheckMate-649, the FDA approved Nivolumab combined chemotherapy for first-line treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma, regardless of PD-L1 expression. At the same time, this is also the first first-line immunotherapy approved by the FDA for gastric cancer.However, there is no definite conclusion about the preoperative neoadjuvant or perioperative clinical research, so it is necessary to explore the efficacy of PD-1 antibody in the perioperative period. This study is a single-center, randomized, controlled phase II clinical study. The primary endpoint of the study is the perioperative administration of mFOLFIRINOX regimen combined with PD-1 antibody and D2 radical resection for the treatment of resectable advanced gastric cancer. The deep tumor remission rate (TRG0 and TRG1) , secondary endpoints include pCR rate, 3-year DFS rate, safety, R0 resection rate, D2 radical resection rate, 5-year DFS rate, 5-year OS rate.

NCT ID: NCT04908267 Recruiting - High-grade Glioma Clinical Trials

How the Precise Habitats Can Predict the IDH Mutation Status and Prognosis of the Patients With High-grade Gliomas

Start date: August 1, 2022
Phase:
Study type: Observational

High-grade glioma is the most common primary malignant tumor in central nervous system, and its high tumor heterogeneity is the main cause of tumor progression, treatment resistance and recurrence. Habitat imaging is a segmentation technique by dividing tumor regions to characterize tumor heterogeneity based on tumor pathology, blood perfusion, molecular characteristics and other tumor biological features. In some studies, the Hemodynamic Multiparametric Tissue Signature (HTS) method has been proven to be feasible. The Hemodynamic Multiparametric Tissue Signature (HTS) consists of a set of vascular habitats obtained by Dynamic Susceptibility Weighted Contrast Enhanced Magnetic Resonance Imaging (DSC-MRI) of high-grade gliomas using a multiparametric unsupervised analysis method. This allowed them to automatically draw 4 reproducible vascular habitats (High-angiogenic enhancing tumor; Low-angiogenic enhancing tumor; Potentially tumor infiltrated peripheral edema; Vasogenic peripheral edema) which enable to describe the tumor vascular heterogeneity robustly. In other studies, contrast-enhancing mass can divided into spatial habitats by K-means clustering of voxel-wise apparent diffusion coefficient (ADC) and cerebral blood volume (CBV) values to observe the changes of voxels in spatial habitat on the time line. Using this so-called spatiotemporal habitat to identify progression or pseudoprogression in cancer therapy. Above all, we have sufficient and firm reasons to deem that habitat imaging based on multiparametric MRI is more conducive to reflect the potential biological information inside the tumor and realize individualized diagnosis and treatment. To sum up, the assumption of this experiment is that the Habitats Created by preoperative or postoperative Multiparametric MRI ,such as conventional MRI sequences, Dynamic Susceptibility Weighted Contrast Enhanced Magnetic Resonance Imaging (DSC-MRI), Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI), Diffusion Weighted Magnetic Resonance Imaging(DWI) ,Vessel Size Imaging (VSI) ,or Magnetic Resonance Spectroscopy (MRS) can predict the molecular mutation status, prognosis, treatment residence, progression, pseudoprogression, and even recurrence and distant intracranial recurrence in patients with high-grade gliomas.

NCT ID: NCT04908046 Recruiting - Clinical trials for Advanced Malignant Solid Tumors

A Study of HMPL-295S1 in Patients With Advanced Malignant Solid Tumors

Start date: May 27, 2021
Phase: Phase 1
Study type: Interventional

The objective of this study is to evaluate the safety, tolerability and PK profile of HMPL-295S1 and determine MTD and/or RP2D in patients with advanced malignant solid tumor. It will be extended to enroll 10-15 patients at this dose after RP2D is determined, as to further evaluate the safety of RP2D and the preliminary efficacy of HMPL-295S1. In addition, an exploratory study on the pharmacokinetic biomarkers of HMPL-295S1 is planned in this study.

NCT ID: NCT04907747 Recruiting - Clinical trials for Helicobacter Pylori Infection

Efficacy and Safety of Vonoprazan as First-line Treatment for Helicobacter Pylori Eradication

Start date: May 18, 2021
Phase: Phase 4
Study type: Interventional

This study aims to evaluate the efficacy of vonoprazan compared with esomeprazole as first-line treatment for Helicobacter Pylori(Hp) eradication, as well as the safety and economic benefits.

NCT ID: NCT04907669 Recruiting - Suicide Clinical Trials

An Implementation Study of Suicide Risk Management Among Discharged Psychiatric Patients

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The post-discharge suicide risk among psychiatric patients is significantly higher than it among patients with other diseases and general population. The brief contact interventions (BCIs) are recommended to decrease the risk in areas with limited mental health service resource like China, however the best frequency to implement BCIs is unknown. This implementation study aims to 1) to develop an intervention strategy against post-discharge suicide based on BCIs for Chinese psychiatric patients; 2) to determine the best frequency of BCIs based on Sequential Multiple Assignment Randomized Trial; 3) to evaluate the effectiveness of the intervention strategy and explore its implementability based on the Implementation Outcome Framework (IOF). Based on the community-based participatory research (CBPR) approach, this study will invite psychiatric patients and family members, psychiatrist and nurses, community mental health workers and social workers as the community team to develop a post-discharge suicide intervention strategy. The study will recruit patients with psychotic symptoms and with major depressive disorder discharged from Shenzhen Kangning Hospital (SKH) in a Sequential Multiple Assignment Randomized Trial (SMART) to determine the best frequency for implementing BCIs and to evaluate the effectiveness. Participants will be randomized into two intervention groups to receive BCIs at different frequencies. Follow-ups to evaluate participants' suicide risk are scheduled at 1, 3, 6 and 12 months after discharge. The re-randomization will be applied at 3 months after discharge. With the Intent-to-treat (ITT) approach, generalized estimating equation (GEE) and survival analysis (SA) will be applied to compare the effectiveness among groups and to explore factors associated with suicide risk. Meanwhile, this study will collect qualitative and quantitative information on implementation and service outcomes from the community team.

NCT ID: NCT04906915 Recruiting - Intensive Care Unit Clinical Trials

Effect of Ketamine Assisted Analgesia on Oxygen Supply and Oxygen Consumption in Patients After Cardiac Surgery

Start date: May 8, 2021
Phase: N/A
Study type: Interventional

After cardiopulmonary bypass heart surgery, with the rewarming of body temperature, the metabolic capacity of the body is enhanced, the microcirculation is opened, and tissue perfusion is increased. At the same time, the body pays off the oxygen debt formed by the low temperature and reduced blood flow in cardiopulmonary bypass, so that the tissue oxygen demand increases and oxygen consumption increases.Analgesia and sedation are important treatment measures for patients after cardiopulmonary bypass. S-isomer of ketamine and eselamine enhanced the sedation and enhanced the analgesic effect, but whether it can improve the imbalance of oxygen supply and oxygen consumption after cardiopulmonary bypass is unknown.

NCT ID: NCT04906733 Recruiting - Colon Cancer Clinical Trials

Cetuximab Sensitivity Correlation Between Patient-Derived Organoids and Clinical Response in Colon Cancer Patients.

Start date: April 15, 2021
Phase:
Study type: Observational

Eighty patients with RAS/RAF wild-type metastatic right colon cancer will be enrolled and undergo a fresh biopsy of tumor lesion before the standard treatment of chemotherapy. The investigators will establish organoids from the pre-treatment biopsies. Organoids will be exposed to the chemotherapy drugs or chemotherapy drugs combined with cetuximab used for each patient. The sensitivity of chemotherapy drugs or combined cetuximab will be tested in the organoids model. Chemotherapy strategies including 5-fluorouracil only, irinotecan only, oxaliplatin only, FOLFOX, and FOLFIRI. The purpose of this study is to evaluate the consistency and accuracy of a Patient-Derived Organoid (PDO) model of colon cancer to predict the clinical efficacy of combined treatment of cetuximab, which to formulate the best therapy regimen for each given patient.