OncoMatch/Clinical Trials/NCT06109207
Neoadjuvant Camrelizumab With Dalpiciclib for Resectable Head and Neck Squamous Cell Carcinomas
Is NCT06109207 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Camrelizumab and Dalpiciclib 100mg for head and neck squamous cell carcinoma.
Treatment: Camrelizumab · Dalpiciclib 100mg · Dalpiciclib 150mg — The purpose of this study is to explore the safety and feasibility of anti-programmed cell death protein 1(PD-1) immunotherapy, Camrelizumab, combined with cyclin-dependent kinase 4/6 blockade, Dalpiciclib, as a new neoadjuvant treatment regimen for patients with resectable head and neck squamous cell carcinoma(HNSCC).
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Excluded: Stage DISTANT METASTASIS
were newly diagnosed and without distant metastasis; were deemed surgically resectable evaluated by a head and neck surgeon
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
prior therapy with: anti-PD-1
Cannot have received: anti-PD-L1 therapy
prior therapy with: anti-PD-L1/2
Cannot have received: anti-PD-L2 therapy
prior therapy with: anti-PD-L1/2
Cannot have received: anti-CTLA-4 therapy
prior therapy with: anti-CTLA-4 antibody
Cannot have received: anti-EGFR antibody
prior therapy with: anti-EGFR antibody
Cannot have received: EGFR tyrosine kinase inhibitor
prior therapy with: EGFR-TKIs
Cannot have received: antitumor vaccine
prior therapy with: antitumor vaccine
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 ≥ 80 g/L, platelets ≥ 80 × 10^9/L
Kidney function
creatinine clearance ≥ 60 ml/min
Liver function
ALT, AST and ALP < 2.5× ULN, total bilirubin ≤ 2×ULN; albumin ≥ 2.8 g/dL
Cardiac function
INR ≤ 1.5; APTT ≤ 1.5×ULN; ejection fraction < 50% excluded
Adequate organ and bone marrow function: absolute neutrophil count ≥ 1.5 × 10^9/L, hemoglobin ≥ 80 g/L, platelets ≥ 80 × 10^9/L; ALT, AST and ALP < 2.5× ULN, total bilirubin ≤ 2×ULN; albumin ≥ 2.8 g/dL; creatinine clearance ≥ 60 ml/min; INR ≤ 1.5; APTT ≤ 1.5×ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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