Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
HNSCC, Neoadjuvant immunochemotherapy
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.
Interventions
None listed
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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；
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 6 months | Adverse events should be collected, followed up and reported in accordance with prescribed procedures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Pathological Response | 6 months | MPR, defined as ≤10% of residual surviving tumors |
| Complete Pathological Response | 6 months | CPR, defined as no residual survivable tumor cells |
Countries
China
Contacts
Primary ContactFuming Qiu, PhD
Outcome results
None listed