OncoMatch/Clinical Trials/NCT06102395
Evaluating the Efficacy and Safety of Pembrolizumab Plus Standard Chemotherapy in the Neoadjuvant Treatment of Local Advanced (LA) HNSCC
Is NCT06102395 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for head and neck squamous cell carcinoma.
Treatment: Pembrolizumab · Cisplatin · Carboplatin · Nedaplatin · Nab paclitaxel · Docetaxel · Liposomal paclitaxel · Fluorouracil — This study is a prospective, open-label, multi-center phase III study; patients with untreated stage IIIA to stage IVB head and neck squamous cell carcinoma (including oral cavity cancer, oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer) who meet the inclusion criteria are randomized 1:1 and given pembrolizumab 200 mg d1+ chemotherapy for 2 cycles (experimental group), 2 cycles of chemotherapy (control group), and then stratified according to the patient's condition. If the imaging evaluation after neoadjuvant treatment is (complete response, CR), adjuvant radiotherapy will be given; if the imaging evaluation is (partial response, PR) or (stable disease, SD), surgery (within 2 weeks) will be performed, followed by standard treatment. The main research hypothesis of this study: pembrolizumab combined with standard chemotherapy can significantly improve the rate of pathological complete response (pCR) compared with standard chemotherapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage IIIA, IIIB, IVA, IVB
Excluded: Stage DISTANT METASTASIS
stage IIIA-IVB head and neck squamous cell carcinoma confirmed by histology and/or cytology; Presence of distant metastasis [excluded]
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: immunotherapy
Have not received immunotherapy in the past
Cannot have received: allogeneic tissue/solid organ transplant
Previous allogeneic tissue/solid organ transplant
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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