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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06011993
• Other study ID #: neoHNSCC
• Status: Recruiting
• Start date: July 19, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: June 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Fuming Qiu, PhD
• Phone: 13858005908
• Email: qiufuming[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Adverse events should be collected, followed up and reported in accordance with prescribed procedures.	6 months
Secondary	Major Pathological Response	MPR, defined as =10% of residual surviving tumors	6 months
Secondary	Complete Pathological Response	CPR, defined as no residual survivable tumor cells	6 months