Real-world Analysis on the Efficacy and Safety of Neoadjuvant Therapy for Head and Neck Squamous Cell Carcinoma （neoHNSCC）

Zhejiang University

Status: Enrolling

Conditions: Head and Neck Squamous Cell Carcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT06011993

neoHNSCC

Details and patient eligibility

About

This is a retrospective, single-arm study that assesses the efficacy and safety of neoadjuvant immunotherapy combined with platinum-based chemotherapy for Head and Neck Squamous Cell Carcinoma. This trial will also explore the biomarkers of neoadjuvant immunochemotherapy.

Full description

This is a retrospective, single-arm study that assesses the efficacy and safety of neoadjuvant immunotherapy combined with platinum-based chemotherapy for Head and Neck Squamous Cell Carcinoma. This trial will also explore the biomarkers of neoadjuvant immunochemotherapy. Patients with untreated, operable, or potentially resectable HNSCC will be included.The pathological results, adverse events and other information of eligible patients will be collected.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-80, male or female；
• Cytologically or histologically diagnosed squamous cell carcinoma (except mixed squamous cell carcinoma)；
• There was at least one radiographically measurable lesion according to the solid tumor response Evaluation Criteria (RECIST version 1.1)；
• Patients with untreated, operable, or potentially resectable head and neck squamous cell carcinoma；

Exclusion criteria

• Malignant diseases other than head and neck squamous cell carcinoma diagnosed within 5 years prior to first administration (excluding basal cell carcinoma of the skin after radical treatment, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection)；
• Currently participating in an interventional clinical study or has received another investigational drug or has used investigational devices in the 4 weeks prior to initial dosing；
• Evidence of medical history or disease that may interfere with trial results, prevent participants from participating fully in the study, abnormal treatment or laboratory test values, or other conditions that the investigator deems unsuitable for enrollment；