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OncoMatch/Clinical Trials/NCT05798793

Neoadjuvant Anti-PD-1 Immunotherapy With Chemotherapy in Resectable Locally Advanced Oral Squamous Cell Carcinoma

Is NCT05798793 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Camrelizumab plus TP and TP for oral squamous cell carcinoma.

Phase 3RecruitingHospital of Stomatology, Wuhan UniversityNCT05798793Data as of May 2026

Treatment: Camrelizumab plus TP · TPThe purpose of this study is to investigate the survival benefit of neoadjuvant anti-PD-1 immunotherapy plus TP chemotherapy compared with TP chemotherapy or up-front surgery in resectable locally advanced oral squamous cell carcinoma.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Disease stage

Required: Stage T1-2N1-2M0, T3-4AN0-2M0

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: cancer therapy (surgery, chemotherapy, radiotherapy, molecular targeted therapy)

History of other treatments for cancer, including surgery, chemotherapy, radiotherapy or molecular targeted therapy within past 5 years

Cannot have received: anti-PD-1/PD-L1/PD-L2/CTLA-4 or other antibody targeting T cell co-regulatory pathways

Previous therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 or any other antibody targeting T cell co-regulatory pathways

Lab requirements

Blood counts

leukocyte count ≥ 2,000/mm3; absolute neutrophil count ≥ 1,000/mm3; platelet count ≥ 100,000/mm3; hemoglobin ≥ 90 g/l; serum albumin ≥30 g/l; prothrombin time-international normalized ratio ≤ 1.5; inr/pt≤ 1.5; tsh ≤ uln

Kidney function

serum creatinine ≤ 1.5 × uln

Liver function

total bilirubin ≤ 1.5 × uln; ast (sgot) and alt (sgpt) < 2.5 × uln; alp ≤ 2.5 × uln

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

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