OncoMatch/Clinical Trials/NCT06109207
Neoadjuvant Camrelizumab With Dalpiciclib for Resectable Head and Neck Squamous Cell Carcinomas
Is NCT06109207 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Other
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.
Frequently asked questions
Is NCT06109207 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages