Effects of Neoadjuvant Therapy With Carboplatin, Paclitaxel Combined With Anti-PD-1 Drugs on Cognitive Function in Patients With Resectable Head and Neck Squamous Cell Carcinoma: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- cognitive adverse events, CoAE
研究概览
简要总结
The goal of this observational study is to learn about the Effects of neoadjuvant therapy with carboplatin, paclitaxel combined with anti-PD-1 drugs on cognitive function in patients with resectable head and neck squamous cell carcinoma: a prospective cohort study
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1: The patient was diagnosed with head and neck squamous cell carcinoma (stage I-IVA), without treatment, and planned to undergo only surgical treatment or surgical treatment + chemotherapy and immunotherapy.
- •2: Can speak Chinese and have certain reading and writing skills
- •3: Healthy group: Dental inpatients with non-oral cancer, no history of neurological diseases, and no previous history of malignant tumors
排除标准
- •1: Brain tumor, brain injury, or stroke at baseline or during follow-up
- •2: A history of stroke or a medical condition that puts you at high risk for future dementia or recurrence
- •3: Active mental illness or active narcotic drug use, including using alcohol more than 4 times per day or more than 4 times per week
- •4: Neurocognitive diseases that affect cognitive function, such as Parkinson's disease or Alzheimer's disease
- •5: History of drug-associated encephalopathy or brain infection
- •6: Patients who change their treatment plan during treatment
- •7: Patients who are currently taking or have taken antidepressants
研究组 & 干预措施
Neoadjuvant therapy+ Surgery group( Group A)
The patient was diagnosed with head and neck squamous cell carcinoma (stage I-IVA), untreated, and planned to undergo surgical treatment + combined chemotherapy and immunotherapy.
干预措施: Carboplatin（ neoadjuvant） (Drug)
Neoadjuvant therapy+ Surgery group( Group A)
The patient was diagnosed with head and neck squamous cell carcinoma (stage I-IVA), untreated, and planned to undergo surgical treatment + combined chemotherapy and immunotherapy.
干预措施: Paclitaxel （neoadjuvant） (Drug)
Neoadjuvant therapy+ Surgery group( Group A)
The patient was diagnosed with head and neck squamous cell carcinoma (stage I-IVA), untreated, and planned to undergo surgical treatment + combined chemotherapy and immunotherapy.
干预措施: Anti-PD-1 Drugs (Drug)
Neoadjuvant therapy+ Surgery group( Group A)
The patient was diagnosed with head and neck squamous cell carcinoma (stage I-IVA), untreated, and planned to undergo surgical treatment + combined chemotherapy and immunotherapy.
干预措施: Surgical resection (Procedure)
Direct surgery group (Group B)
The patient was diagnosed with head and neck squamous cell carcinoma (stage I-IVA), untreated, and planned to undergo surgery.
干预措施: Surgical resection (Procedure)
结局指标
主要结局
cognitive adverse events, CoAE
时间窗: Baseline, 9 weeks, 6 months, 12 months
Scores on two or more of the neuropsychological battery tests (NBT) of the HVLT-R, COWA, and TMT are 1.5 SD below the standard mean (or the mean score of an appropriate control group), Or a single test score that is 2.0 SD below the mean can be marked as an objective cognitive adverse event (CoAE).
次要结局
- Major pathological response rate(Within 30 days after surgery)
- Montreal Cognitive Assessment, MoCA(The total score is obtained by adding up the scores of each item, and the full score is 30 points. The application results of the original English version of the scale designer show that if the number of years of education is ≤12 years, 1 point is added,)
- perceived cognitive decline events , PCDE(1/2 standard deviation (SD) of the PCI score in the baseline healthy population is defined as a minimal clinically important difference (MCID), and a change in PCI score that exceeds the MCID in each test will be labeled as PCDE.)
- complete pathological response rate(Within 30 days after surgery)
研究者
Song Fan, MD
Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University