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OncoMatch/Clinical Trials/NCT04826679

Neoadjuvant Camrelizumab in Combination With Cisplatin and Nab-paclitaxel in Resectable HNSCC

Is NCT04826679 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Camrelizumab, nab-paclitaxel, cisplatin for head and neck squamous cell carcinoma.

Phase 2RecruitingSun Yat-sen UniversityNCT04826679Data as of May 2026

Treatment: Camrelizumab, nab-paclitaxel, cisplatinThis study is a single arm phase II trial including 53 patients with T2N2-3M0、T3-4N0-3M0(III-IV) head and neck squamous cell carcinoma (HNSCC) eligible for resection, who receive neo-adjvuant Camrelizumab combined with cisplatin and Nab-paclitaxel. This proposed study will evaluate the efficacy and safety of preoperative administration of Camrelizumab combined with chemotherapy in Head and Neck Squamous Cell Carcinoma (HNSCC) who are about to undergo surgery.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Disease stage

Required: Stage T2N2-3M0, T3-4N0-3M0, III, IV (AJCC 8.0)

T2N2-3M0、T3-4N0-3M0(III-IV)(AJCC 8.0)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: anti-PD-1 therapy

Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.

Cannot have received: anti-PD-L1 therapy

Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.

Cannot have received: anti-PD-L2 therapy

Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.

Cannot have received: anti-CTLA-4 therapy

Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.

Cannot have received: immune checkpoint inhibitor

any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways

Cannot have received: anti-tumor herbs

have received anti-tumor herbs within 4 weeks before randomization

Lab requirements

Blood counts

WBC≥4000/μL、NE≥2.000/μL、HGB≥9 g/dL、PLT≥100000/μL

Kidney function

Serum creatinine < 1.5x ULN or CrCl > 60mL/min (if using the Cockcroft-Gault formula below)

Liver function

Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3 x ULN); AST/ALT ≤ 3 x ULN and ALP≤3 x ULN; ALB≥3g / dL

Cardiac function

adequate cardiac function

Adequate hepatic、cardiac、brain and renal function as demonstrated by 1) Hematology: WBC≥4000/μL、NE≥2.000/μL、HGB≥9 g/dL、PLT≥100000/μL; 2) Renal: Serum creatinine < 1.5x ULN or CrCl > 60mL/min (if using the Cockcroft-Gault formula below): 3) Hepatic: Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3 x ULN);AST/ALT ≤ 3 x ULN and ALP≤3 x ULN;ALB≥3g / dL;

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

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