Serum Exosomal miRNA Predicting the Therapeutic Efficiency in Lung Squamous Carcinoma
Observacional
Fase no especificada
TianjinCIH
Patrocinador: Tianjin Medical University Cancer Institute and Hospital
Última actualización: 11 de mayo de 2023 Aviso: La información proviene de registros públicos y puede no reflejar cambios en tiempo real en el centro local.
This is an observational prospective bi-center study of 50 patients operated on advanced squamous cell carcinoma. The main aim is to investigate the efficacy of serum exosomal miRNA as a biomarker for predicting the therapeutic effect of immunotherapy combined with chemotherapy.
1. Histology or cytology confirmed patients with stage IV squamous cell carcinoma of IASLC TNM (8th edition);
2. Patients have not previously received first-line anti-tumor systemic therapy for advanced lung cancer;
3. At least one measurable lesion according to the irRECIST 1.1 standard;
4. Physical condition and organ function allow for systemic antitumor therapy, including standard chemotherapy and immunotherapy;
5. Age ≥ 18 years at the time of signing the informed consent form;
6. Estimated survival≥ 3 months;
7. Patients can follow the planned schedule and actively cooperate in returning to the hospital for regular clinical follow-up and necessary treatment;
8. It can provide the clinical data required for research and is willing to use the test data for further scientific research and commercial product development.
Criterios de exclusión
1. Other malignancies within the last 5 years (except adequately treated carcinoma in situ and basal or squamous cell skin cancer);
2. The investigators judged that the patient also had other serious medical conditions that could affect follow-up and short-term survival;
3. Any other medical condition and social/psychological problems which the investigator determines that the patient is not suitable to participate in this study;
4. Contrast-enhanced MRI or contrast-enhanced CT for clinical follow-up is not acceptable;
5. Have an active or previous auto-immune disease that is likely to recur;
6. Other antineoplastic therapies were planned for the duration of the study.
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Detalles del diseño
AsignaciónN/A
Modelo de intervenciónN/A
EnmascaramientoN/A
Número a inscribir60
Brazos e Intervenciones
Brazos
Intervenciones
Tipo:
Descripción: advanced pulmonary carcinoma with pathological diagnosis of squamous cell and are applied with first line treatment of anti-PD-L1 combined with chemotherapy
Intervenciones:
collect plasma samples and clinical features
Medidas de resultado
Medidas de resultado primarias
plasma exosomal miRNA levelBaseline up to 21 days
The expression levels of serum exosome micro RNA
PD-L1Baseline up to 21 days
the expression levels of PD-L1
Imaging data of lesionsFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Imaging data of the pulmonary and metastatic lesions of the patients are collected
Objective response rateFrom the start of systemic treatment date until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 100 months
Medidas de resultado secundarias
Ninguno
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