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NCT ID: NCT06142058 Recruiting - NSCLC Clinical Trials

RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for NSCLC

Start date: November 13, 2023
Phase:
Study type: Observational

Investigators established the efficacy evaluation criteria for tumor markers (RecistTM) in the preliminary research. Among patients with advanced non-small cell lung cancer, patients with positive driving genes are more likely to exhibit abnormalities in tumor markers, which suggests that this criteria may be more suitable for evaluating the efficacy of targeted therapy in driving gene positive patients. Moreover, The judgment rules of the prelimary criteria still need further improvement. Therefore, in order to broaden the application scope of the RecistTM criteria, further improve the evaluation rules of RecistTM criteria, and multi-dimensionally confirm the reliability of RecistTM criteria on efficacy evaluation, investigators plan to conduct research on the application of RecistTM criteria in evaluating the efficacy of targeted therapy for advanced non-small cell lung cancer with positive driving genes.

NCT ID: NCT06141486 Recruiting - Multiple Sclerosis Clinical Trials

Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis

Start date: December 27, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to approximately 51 months administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: - This event-driven study will have variable duration ranging from approximately 27 to 51 months. - The study intervention duration will vary ranging from approximately 27 to 51 months. - The number of scheduled visits will be up to 27 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months.

NCT ID: NCT06141473 Recruiting - Multiple Sclerosis Clinical Trials

Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis

Start date: December 13, 2023
Phase: Phase 3
Study type: Interventional

The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years at the time of enrollment). People diagnosed with relapsing forms of multiple sclerosis are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: - This event-driven study will have variable duration of approximately 40 months for the first participant being randomized and approximately 20 months for the last participant randomized. - The study intervention duration will vary ranging from approximately 20 to 40 months. - The assessment of scheduled visits will include 1 common end of study [EOS] visit and 3 follow-up visits) with a visit frequency of every 4 weeks for the first 6 months and then every 3 months.

NCT ID: NCT06141460 Recruiting - Clinical trials for Neovascular Age-related Macular Degeneration

Safety and Efficacy of RRG001 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

Start date: December 5, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

RRG001 is a adeno-associated virus (AAV) vector-based gene therapy for subretinal injection. The long-term, stable therapeutic protein after one time injection for nAMD could potentially reduce the treatment burden and maintain vision.RRG001 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.

NCT ID: NCT06141421 Recruiting - Clinical trials for Single-Port Colorectal Surgeries

A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Colorectal Surgeries(SPiM-RWS-CR)

Start date: March 28, 2023
Phase:
Study type: Observational

A real-world study to evaluate the clinical performance and safety of da Vinci SP Surgical System ("SP single-port robot" for short) for single-port robot-assisted colorectal surgeries in the real world, providing a real world evidence for clinical application of the product in the Chinese population. English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.

NCT ID: NCT06141369 Recruiting - Clinical trials for Pancreatic Neuroendocrine Tumor

Treatment of Advanced Endocrine Tumor With Iindividualized mRNA Neoantigen Vaccine (mRNA-0523-L001)

Start date: January 13, 2024
Phase: N/A
Study type: Interventional

Treatment of advanced endocrine tumors, including adrenal corticocarcnioma (ACC), medullary thyroid carcinoma (MTC), thymic neuroendocrine tumor and pancreatic neuroendocrine tumor is challenging. Previous genomic profiling studies showed they presented a number of somatic mutations. The tumors Individualized mRNA neoantigen vaccine provide a promising solution since a significant portion of these tumors showed high quality of tumor specific neoantigen. The primary objective is to observe and evaluate the safety and tolerability of individualized mRNA neoantigen vaccine (mRNA-0523-L001) for the treatment of advanced endocrine tumors, failure of standard treatment or no standard treatment currently available. The secondary objective is to observe the preliminary efficacy of mRNA-0523-L001 for the treatment of advanced endocrine tumors, failure of standard treatment or no standard treatment currently available, including: 1. Neoantigen-specific CD4+ and CD8+ T lymphocyte responses induced by mRNA-0523-L001; 2. Objective response rate (ORR) and disease control rate (DCR) of tumors; 3. Progression-free survival (PFS).

NCT ID: NCT06141356 Recruiting - Alzheimer's Disease Clinical Trials

[18F]Florbetazine ([18F]92) for Beta Amyloid PET Imaging in Alzheimer's Disease

Start date: January 30, 2023
Phase:
Study type: Observational

[18F]Florbetazine ([18F]92) is a molecularly targeted imaging agent for Aβ protein with a novel diaryl-azine scaffold. It has shown specific binding affinity to Aβ aggregates in postmortem human AD brains and excellent brain pharmacokinetic properties with little non-specific retention in white matter in animal studies and a limited number of patients with Alzheimer's Disease (AD). The purpose of the current study is to examine the binding properties of [18F]Florbetazine in human subjects and to compare the cortical and white matter binding with [11C]PiB or [18F]Florbetapir in the same subjects. Imaging of the brain will be completed in healthy adult normal control participants and participants with cognitive impairment (including probable AD and dementia due to other conditions) to characterize [18F]Florbetazine uptake in the brain and its binding properties. [11C]PIB or [18F]Florbetapir PET imaging along with MRI will be completed in the same participants and the data will be compared with 18F-[18F]Florbetazine.

NCT ID: NCT06141265 Recruiting - Clinical trials for Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma

Niraparib Maintenance in HRD-Positive Advanced Ovarian Cancer Following Front-Line Chemotherapy + Bevacizumab

BRAND
Start date: November 1, 2023
Phase: Phase 2
Study type: Interventional

This study is a multicenter, open-label, single-arm phase II clinical trial investigating the efficacy and safety of niraparib monotherapy maintenance in HRD-positive newly diagnosed advanced epithelial ovarian cancer (EOC), including primary peritoneal and/or fallopian tube tumors, following response to front-line chemotherapy in combination with bevacizumab. A total of 116 patients will be enrolled.

NCT ID: NCT06141226 Recruiting - Clinical trials for Non-small-cell Lung Cancer

Phase II Clinical Trial to Evaluate the Safety and Efficacy of TQB2450 Injection Combined With Anlotinib Capsule and Chemotherapy in the Treatment of Immunoresistant Advanced Non-small Cell Lung Cancer

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

Objective to compare the efficacy and safety of TQB2450 injection combined with anlotinib and chemotherapy, and TQB2450 injection combined with chemotherapy in the treatment of advanced non-small cell lung cancer subjects who failed to receive first-line chemotherapy combined with immunization, and to explore and evaluate biomarkers related to efficacy, mechanism of action / resistance mechanism, and safety.

NCT ID: NCT06141213 Recruiting - Clinical trials for Chromosome Aberrations

The Relationship Between Fetal Membrane Thickness and Fetal Chromosomal Aneuploidies

PLACE2102
Start date: October 1, 2021
Phase:
Study type: Observational

This observational study aims to recruit pregnant women between 18 to 24 weeks of gestation to investigate the relationship between amniotic membrane thickness and fetal chromosomal abnormalities. The primary objectives are to establish whether a correlation exists between the measured thickness of the amniotic membrane and the presence of chromosomal abnormalities in the fetus, and to determine a cutoff value for amniotic membrane thickness that could indicate an increased risk of such abnormalities. Additionally, the study seeks to assess whether the inclusion of amniotic membrane thickness as a biomarker can enhance the detection rate of non-invasive prenatal testing (NIPT) and nuchal translucency (NT) for chromosomal abnormalities.