Analysis of neoadjuvant therapy for head and neck cancer
Real-world Analysis on the Efficacy and Safety of Neoadjuvant Therapy for Head and Neck Squamous Cell Carcinoma （neoHNSCC）
This study is testing if a new treatment combining immunotherapy and chemotherapy can help people with head and neck cancer before their surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06011993 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the efficacy and safety of neoadjuvant immunotherapy combined with platinum-based chemotherapy in patients with head and neck squamous cell carcinoma (HNSCC). It is a retrospective, single-arm study that will collect data on pathological results, adverse events, and other relevant information from patients with untreated, operable, or potentially resectable HNSCC. The study also aims to explore biomarkers associated with the neoadjuvant immunochemotherapy approach.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-80 with untreated, operable, or potentially resectable head and neck squamous cell carcinoma.
Not a fit: Patients with other malignant diseases diagnosed within the last 5 years or those currently participating in interventional studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective treatment strategies for patients with head and neck squamous cell carcinoma.
How similar studies have performed: Other studies have shown promise in using neoadjuvant immunotherapy for similar conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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；
Where this trial is running
Hangzhou, Zhejiang
- Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Fuming Qiu, PhD
- Email: qiufuming@zju.edu.cn
- Phone: 13858005908
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.