RecruitingPhase 2NCT06100497

Efficacy and Safety of PD-1 Plus Chemotherapy in Poorly Differentiated Locally Advanced (LA) HNSCC

Efficacy and Safety of PD-1 Inhibitor Combined With Chemotherapy in Locally Advanced (III-IVB) Poorly Differentiated Head and Neck Squamous Cell Carcinoma: a Multi Cohort, Prospective Phase II Study


Sponsor

Beijing Tongren Hospital

Enrollment

100 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Patients with locally advanced (stage III to stage IVB) poorly differentiated head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) who meet the inclusion criteria will have their blood samples collected, tumor tissue samples or patient paraffin tissue, and slides for comprehensive genomic sequencing and analysis. The study is divided into two groups. Arm1 group: Patients with stage IVB (T4bNxM0) poorly differentiated head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) will receive PD-1 combined with platinum-based chemotherapy and albumin-bound paclitaxel (dose according to the drug instructions) for 2 to 3 cycles (determined by the researcher based on tumor shrinkage). If the imaging achieves complete response (CR) or partial response (PR), suitable patients will undergo surgical treatment. Patients who are not suitable for surgery or have stable disease (SD)/progressive disease (PD) will receive concurrent chemoradiotherapy or concurrent chemoradiotherapy combined with PD-1 treatment (up to a total of 17 cycles). Arm2 group: Patients with stage III and IVA (T3NxM0, T4aNxM0) poorly differentiated head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) will receive PD-1 combined with platinum-based chemotherapy and albumin-bound paclitaxel (dose according to the drug instructions) for 2 cycles. Patients who undergo surgery within 2 weeks will receive PD-1 monotherapy maintenance treatment or low-dose radiotherapy followed by PD-1 monotherapy maintenance treatment based on pathological results. Patients who do not achieve pathological complete response (pCR) and have positive surgical margins or extracapsular extension will receive concurrent chemoradiotherapy followed by PD-1 maintenance treatment (up to a total of 17 cycles). Patients without high-risk factors will receive PD-1 maintenance treatment after radiotherapy (up to a total of 17 cycles). After completion of treatment, all patients will be followed up every 3 months for 1 year. Subsequently, patients will be followed up every 6 months for 3 years. Thereafter, patients will be followed up annually. Patient recurrence and survival data will be recorded.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an immunotherapy drug (a PD-1 inhibitor) combined with chemotherapy (platinum-based drugs plus albumin-bound paclitaxel) as an initial or pre-surgery treatment for people with locally advanced, poorly differentiated (aggressive) head and neck cancer. It excludes nasopharyngeal cancer and focuses on cancers of the throat, voice box, sinuses, and surrounding areas. **You may be eligible if...** - You are 18 years or older - You have been confirmed to have locally advanced (Stage III–IVB) poorly differentiated head and neck cancer (throat, larynx, oropharynx, nasal cavity, or sinus — but NOT nasopharyngeal cancer) - Your cancer has not yet been treated with systemic therapy or immunotherapy - You are in good health (ECOG 0–1) - Your disease is measurable on imaging - Your blood counts, liver, and kidney functions are adequate **You may NOT be eligible if...** - Your cancer has already spread to distant organs (distant metastases) - You have significant autoimmune conditions - You have received prior immunotherapy or chemotherapy for this cancer - You have severe heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Mainly used for neoadjuvant treatment and subsequent adjuvant or maintenance treatment

DRUGCisplatin

Mainly used for neoadjuvant treatment and concurrent chemoradiotherapy

DRUGPaclitaxel-albumin

Mainly used for neoadjuvant treatment


Locations(1)

Beijing Tongren Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

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NCT06100497


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