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

Официальное название

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

Обзор

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

Вмешательства

• Препарат Carboplatin（ neoadjuvant）
  Carboplatin (IV), AUC=5，administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
• Препарат Paclitaxel （neoadjuvant）
  Paclitaxel 260mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
• Препарат Anti-PD-1 Drugs
  Anti-PD-1 Drugs 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
• Процедура Surgical resection
  Standard of care

Первичные конечные точки

• cognitive adverse events, CoAE [Срок оценки: Baseline, 9 weeks, 6 months, 12 months]

Вторичные конечные точки (4)

• Major pathological response rate [Срок оценки: Within 30 days after surgery]
• Montreal Cognitive Assessment, MoCA [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Within 30 days after surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Китай · 1 центр

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — Guanzhou

Идентификаторы

NCT: NCT06576180 · SYSKY-2024-647-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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