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

NCT ID: NCT06011993

Last Updated: 2023-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-19
• Study Completion Date: 2023-12-01

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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；

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fuming Qiu, PhD

Role: CONTACT

qiufuming@zju.edu.cn

13858005908

Facility Contacts

Fuming Qiu, PhD

Role: primary

qiufuming@zju.edu.cn

13858005908

Other Identifiers

neoHNSCC

Identifier Type: -

Identifier Source: org_study_id