Neoadjuvant Camrelizumab With Dalpiciclib for Resectable Head and Neck Squamous Cell Carcinomas
The Safety and Feasibility of Neoadjuvant Camrelizumab With Dalpiciclib for the Treatment of Resectable Head and Neck Squamous Cell Carcinoma：A Phase 1 Trial
West China Hospital
6 participants
Oct 31, 2023
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria8
- Age 18 years or above.
- Patients with pathologically confirmed HNSCC (except for nasopharyngeal carcinoma) and meet the following conditions:
- were newly diagnosed and without distant metastasis;
- were deemed surgically resectable evaluated by a head and neck surgeon;
- were willing to undergo surgery.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- 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× upper limit of normal (ULN), total bilirubin ≤ 2×ULN;albumin≥ 2.8 g/dL；creatinine clearance ≥ 60 ml/min；INR≤ 1.5；APTT≤ 1.5×ULN
- Written informed consent.
Exclusion Criteria13
- History of other malignancies (except for the history of malignant tumors that have been cured and have not recurred within 5 years, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, in situ cervical cancer, and gastrointestinal mucosal cancer, etc.）
- Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease.
- Any history of allergic disease, or a sever hypersensitivity reaction to drugs, or allergy to the study drug components.
- With serious medical diseases, such as grade II and above cardiac dysfunction (NYHA criteria), ischemic heart disease, supraventricular or ventricular arrhythmia, poorly controlled diabetes mellitus, poorly controlled hypertension, echocardiographic ejection fraction \< 50%, etc.
- With interstitial pneumonitis, non-infectious pneumonitis, active pulmonary tuberculosis, or history of pulmonary tuberculosis infection that were not controlled by treatment.
- With hyperthyroidism, or organic thyroid disease.
- With active infection, or unexplained fever during the screening period or 48 hours before the first dose.
- With active hepatitis B or C, or known history of positive HIV test, or acquired immunodeficiency syndrome.
- History of a clear neurological or psychiatric disorder.
- History of drug abuse or alcohol abuse.
- Women who are pregnant or breastfeeding, or have a reproductive plan from the screening period to 3 months after the end of the study, or have sex without contraceptive measures, or are unwilling to take appropriate contraceptive measures.
- Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial.
- Any other factors that are not suitable for inclusion in this study judged by investigators.
Interventions
Camrelizumab will be given at at a dose of 200 mg intravenously every three weeks on day 1 of a planned 21-day cycle, and two doses before surgery
Dalpiciclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.
Dalpiciclib will be given at a dose of 150 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06109207