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
Study Type
OBSERVATIONAL
Enrollment
306
Carboplatin (IV), AUC=5,administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Paclitaxel 260mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Anti-PD-1 Drugs 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Standard of care
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guanzhou, Guangdong, China
RECRUITINGcognitive adverse events, CoAE
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).
Time frame: Baseline, 9 weeks, 6 months, 12 months
Major pathological response rate
Defined as the proportion of subjects with ≤10% viable tumor cells in resection specimens to total subjects
Time frame: Within 30 days after surgery
Montreal Cognitive Assessment, MoCA
Baseline, 9 weeks, 6 months, 12 months
Time frame: 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
Baseline, 9 weeks, 6 months, 12 months
Time frame: 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
Defined as the proportion of subjects without viable tumor cells in the resection specimen to the total subjects
Time frame: Within 30 days after surgery
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