Efficacy and Safety of PD-1 Plus Chemotherapy in Poorly Differentiated Locally Advanced (LA) HNSCC
Status:
Not yet recruiting
Trial end date:
2028-10-31
Target enrollment:
Participant gender:
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.