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Trial Title:
Real-world Analysis on the Efficacy and Safety of Neoadjuvant Therapy for Head and Neck Squamous Cell Carcinoma （neoHNSCC）
NCT ID:
NCT06011993
Condition:
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Conditions: Keywords:
HNSCC
Neoadjuvant immunochemotherapy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
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.
Criteria for eligibility:
Study pop:
Head and neck squamous cell carcinoma，HNSCC
Sampling method:
Non-Probability Sample
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；
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Fuming Qiu, PhD
Phone:
13858005908
Email:
qiufuming@zju.edu.cn
Start date:
July 19, 2023
Completion date:
December 1, 2023
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06011993
