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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.

Phase 3RecruitingBeijing Tongren HospitalNCT06102395Data as of May 2026

Treatment: Pembrolizumab · Cisplatin · Carboplatin · Nedaplatin · Nab paclitaxel · Docetaxel · Liposomal paclitaxel · FluorouracilThis 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.

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Extracted 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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