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OncoMatch/Clinical Trials/NCT06208826

A Single-center Phase II Study to Investigate the Immune Maintenance Therapy Pattern in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma Who Have Achieved MPR After Neoadjuvant Immunotherapy Combined With Chemotherapy

Is NCT06208826 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Toripalimab and Cisplatin for head and neck cancer.

Phase 2RecruitingTianjin Medical University Cancer Institute and HospitalNCT06208826Data as of May 2026

Treatment: Toripalimab · CisplatinHead and neck cancer is the malignant tumor with the highest morbidity and mortality, of which 60% present with locally advanced disease at initial diagnosis, and the 5-year survival rate of standard treatment is less than 30%. Standard of care (SOC) including adjuvant and neoadjuvant therapy can provides only about 5-10% clinical benefit. According to the available data on the application of immunotherapy as adjuvant therapy in operable patients, adjuvant immunotherapy is safe and feasible, with a significant trend of benefit. Based on the above positive and meaningful clinical needs and scientific basis, it is very necessary to carry out clinical trials of adjuvant immunotherapy. The primary objective of this study is to evaluate the efficacy and safety of immune maintenance therapy in patients with locally advanced head and neck squamous cell carcinoma who achieve MPR after neoadjuvant immunotherapy combined with chemotherapy.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: immunotherapy — neoadjuvant

Achievement of major pathological response (MPR) after surgery with neoadjuvant immunotherapy combined chemotherapy

Must have received: chemotherapy — neoadjuvant

Achievement of major pathological response (MPR) after surgery with neoadjuvant immunotherapy combined chemotherapy

Cannot have received: investigational drug

Received any investigational drug within 4 weeks prior to the first dose

Lab requirements

Blood counts

absolute neutrophil count ≥ 1.5 × 10^9/l, hemoglobin ≥ 9.0g/dl, platelets ≥100000/μl

Kidney function

creatinine clearance ≥ 60 ml/min

Liver function

alt and ast < 2.5× uln, total bilirubin ≤ 1.5×uln

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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