NCT06109207 Neoadjuvant Camrelizumab With Dalpiciclib for Resectable Head and Neck Squamous Cell Carcinomas
| NCT ID | NCT06109207 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | West China Hospital |
| Condition | Head and Neck Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2023-10-31 |
| Primary Completion | 2024-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 6 participants in total. It began in 2023-10-31 with a primary completion date of 2024-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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. * Any of prior therapy with:anti-PD-1, anti-PD-L1/2, anti-CTLA-4 antibody, anti-EGFR antibody or EGFR-TKIs； antitumor vaccine; any active vaccine against an infectious disease within 4 weeks prior to the first dose or planned during the study period; major surgery or serious trauma within 4 weeks before the first dose; toxicity from prior antitumor therapy has not recovered to ≤ CTCAE Version 5.0 ·Grade 1 or the level specified by the inclusion/exclusion criteria. * 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.
Contact & Investigator
Jin Zhou, MD.,PhD.
PRINCIPAL INVESTIGATOR
West China Hospital
Frequently Asked Questions
Who can join the NCT06109207 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06109207 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06109207 currently recruiting?
Yes, NCT06109207 is actively recruiting participants. Contact the research team at zhoujin096@scu.edu.cn for enrollment information.
Where is the NCT06109207 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT06109207 clinical trial?
NCT06109207 is sponsored by West China Hospital. The principal investigator is Jin Zhou, MD.,PhD. at West China Hospital. The trial plans to enroll 6 participants.