NCT04500990Unknown不适用
Magnetic Resonance Imaging (MRI) Diffusion-weighted Imaging (Dwi) None-Gaussian Model Predicting Early Response to Immunotherapy in Digestive System Malignancies: a Prospective Observational Study
Peking University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
This is a prospective two cohorts observational study aimed to investigate the predicting value of MRI none-Gaussian model in digestive malignancies patients who received single agent PD-1/PD-L1 inhibitor or combined immunotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years, ECOG 0-1, expected survival ≥3 months;
- •pathologically confirmed digestive system adenocarcinoma, including but not restricted to gastric adenocarcinoma, colorectal cancer, pancreatic adenocarcinoma et al;
- •pathologically confirmed PD-L1 expression, or MMR-deficient (dMMR)/microsatellite instability (MSI-H) or high tumor mutation burden (TMB-H) or other indication for immunotherapy;
- •at least one target lesion, if there is no target lesion the thickness of cavity viscera lesion should exceed 1cm;
- •patients will receive single agent PD-1/PD-L1 inhibitor, or combined immunotherapy such as: lenvatinib, enrotinib or herceptin;
- •screening laboratory values must meet the following criteria: hemoglobin ≥ 9.0 g/dL; neutrophils ≥ 1500 cells/ μL; platelets ≥ 100 x 10^3/ μL; total bilirubin ≤ 2.0 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; serum creatinine ≤1.5 x ULN, and serum creatinine rate >50μmol/L; activated partial thromboplastin time (APTT)、international normalized ratio (INR), prothrombin lime (PT)≤1.5×ULN;
- •echocardiography: left ventricular ejection fraction≥50%
- •volunteer participate, signed written informed consent form.
排除标准
- •claustrophobia or other contraindication for MRI testing;
- •received prior anti-PD-1/PD-L1 or other immune checkpoint inhibitors;
- •combined immunotherapy contains chemotherapy agent;
- •contain other histology component except adenocarcinoma；
- •hypersensitivity after other monoclonal antibody infusion；
- •coexist other malignancy in last five years;
- •active autoimmune disease, or who received systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 2 weeks of first dose;
- •Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage;
- •obvious bleeding tendency or had CTCAE≥3 grade；
- •subjects are eligible with clinically controlled and stable neurologic function ≥ 4 weeks, which is no evidence of CNS disease progression; subjects with spinal cord compression and cancerous meningitis are not eligible；
- •vaccination within 28 days of the first administration of trial treatment.
结局指标
主要结局
Objective Response Rate
时间窗: from enrollment of the first subject until the database cut-off approximately 12 months later.
The rate of patients reached complete response or partial response.
次要结局
- Progress free survival(from enrollment of the first subject until the database cut-off approximately 12 months later.)
- Overall survival(from enrollment of the first subject until the database cut-off approximately 12 months later.)
研究者
Shen Lin
professor
Peking University
研究点 (1)
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