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
NCT ID: NCT06576180
Last Updated: 2024-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
306 participants
OBSERVATIONAL
2024-08-23
2026-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
Carboplatin（ neoadjuvant）
Carboplatin (IV), AUC=5，administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Paclitaxel （neoadjuvant）
Paclitaxel 260mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Anti-PD-1 Drugs
Anti-PD-1 Drugs 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Surgical resection
Standard of care
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.
Surgical resection
Standard of care
Healthy people (Group C)
Healthy people
No interventions assigned to this group
Interventions
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Carboplatin（ neoadjuvant）
Carboplatin (IV), AUC=5，administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Paclitaxel （neoadjuvant）
Paclitaxel 260mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Anti-PD-1 Drugs
Anti-PD-1 Drugs 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Surgical resection
Standard of care
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Song Fan, MD
Professor
Locations
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guanzhou, Guangdong, China
Countries
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Facility Contacts
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Other Identifiers
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SYSKY-2024-647-01
Identifier Type: -
Identifier Source: org_study_id
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