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

Recruiting

• Conditions: Head and Neck Squamous Cell Carcinoma

• Registration Number: NCT06011993
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2023-06
• Study Start: 2023-07-19
• Study First Submitted: 2023-08-22
• Study First Submitted QC: 2023-08-22
• Last Update Submitted: 2023-08-22
• Study First Posted: 2023-08-25
• Last Update Posted: 2023-08-25
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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；

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events	6 months	Adverse events should be collected, followed up and reported in accordance with prescribed procedures.

Secondary Outcome Measures

Name	Time	Method
Complete Pathological Response	6 months	CPR, defined as no residual survivable tumor cells
Major Pathological Response	6 months	MPR, defined as ≤10% of residual surviving tumors

Trial Locations

Locations (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China