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

Sun Yat-sen University

Status: Enrolling

Conditions: Head and Neck Squamous Cell Carcinoma

Treatments: Drug: Carboplatin（ neoadjuvant）; Procedure: Surgical resection; Drug: Paclitaxel （neoadjuvant）; Drug: Anti-PD-1 Drugs

Study type: Observational

Funder types: Other

Identifiers

NCT06576180

SYSKY-2024-647-01

Details and patient eligibility

About

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

Enrollment: 306 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

306 participants in 3 patient groups

Neoadjuvant therapy+ Surgery group( Group A)

Description:

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.

Treatment:

Drug: Anti-PD-1 Drugs

Drug: Paclitaxel （neoadjuvant）

Procedure: Surgical resection

Drug: Carboplatin（ neoadjuvant）

Direct surgery group (Group B)

Description:

The patient was diagnosed with head and neck squamous cell carcinoma (stage I-IVA), untreated, and planned to undergo surgery.

Treatment:

Procedure: Surgical resection

Healthy people (Group C)

Description:

Healthy people