Actively Recruiting
Neoadjuvant Camrelizumab With Dalpiciclib for Resectable Head and Neck Squamous Cell Carcinomas
Led by West China Hospital · Updated on 2024-07-23
6
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Neoadjuvant Camrelizumab With Dalpiciclib for Resectable Head and Neck Squamous Cell Carcinomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or above
- Pathologically confirmed head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma)
- Newly diagnosed disease without distant metastasis
- Tumor deemed surgically resectable by a head and neck surgeon
- Willingness to undergo surgery
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and bone marrow function, including neutrophil count ≥ 1.5 x 10^9/L, hemoglobin ≥ 80 g/L, platelets ≥ 80 x 10^9/L
- Liver enzymes (ALT, AST, ALP) less than 2.5 times the upper limit of normal
- Total bilirubin ≤ 2 times the upper limit of normal
- Albumin ≥ 2.8 g/dL
- Creatinine clearance ≥ 60 ml/min
- INR ≤ 1.5
- APTT ≤ 1.5 times the upper limit of normal
- Written informed consent
You will not qualify if you...
- History of other malignancies unless cured and no recurrence within 5 years (e.g., certain skin cancers, superficial bladder cancer, in situ cervical cancer, gastrointestinal mucosal cancer)
- Active autoimmune disease requiring systemic treatment or history of severe autoimmune disease
- History of severe allergic reactions or allergies to study drugs
- Prior therapy with anti-PD-1, anti-PD-L1/2, anti-CTLA-4 antibodies, anti-EGFR antibodies, EGFR-TKIs, antitumor vaccines
- Active vaccination against infectious diseases within 4 weeks before first dose or planned during study
- Major surgery or serious trauma within 4 weeks before first dose
- Unresolved toxicity from prior antitumor therapy above grade 1 per CTCAE version 5.0
- Serious medical conditions such as grade II or higher cardiac dysfunction, ischemic heart disease, arrhythmias, poorly controlled diabetes or hypertension, ejection fraction < 50%
- Interstitial pneumonitis, non-infectious pneumonitis, active or uncontrolled pulmonary tuberculosis
- Hyperthyroidism or organic thyroid disease
- Active infection or unexplained fever during screening or within 48 hours before first dose
- Active hepatitis B or C, positive HIV test, or AIDS
- History of neurological or psychiatric disorders
- History of drug or alcohol abuse
- Pregnancy, breastfeeding, or reproductive plans without contraception from screening through 3 months post-study
- Participation in another clinical trial or investigational drug use within 4 weeks before first dose
- Any other factors deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
J
Jin Zhou, MD.,PhD.
CONTACT
S
Shangwei Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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