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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Carboplatin（ neoadjuvant）, Paclitaxel （neoadjuvant）, Anti-PD-1 Drugs, Surgical resection.
- Who it may be relevant to
- Registry conditions: Head and Neck Squamous Cell Carcinoma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
Interventions
- Drug Carboplatin（ neoadjuvant）
Carboplatin (IV), AUC=5，administered by intravenous (IV) infusion on Day 1 of each 21-day cycle - Drug Paclitaxel （neoadjuvant）
Paclitaxel 260mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle - Drug Anti-PD-1 Drugs
Anti-PD-1 Drugs 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle - Procedure Surgical resection
Standard of care
Primary outcome measures
- cognitive adverse events, CoAE [Time frame: Baseline, 9 weeks, 6 months, 12 months]
Secondary outcome measures (4)
- Major pathological response rate [Time frame: Within 30 days after surgery]
- Montreal Cognitive Assessment, MoCA [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 [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 [Time frame: Within 30 days after surgery]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — Guanzhou
Identifiers
NCT: NCT06576180 · SYSKY-2024-647-01