Status:
UNKNOWN
Cetuximab+Zimberelimab in Combination With Cisplatin and Nab-paclitaxel in Resctable Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
Xuekui Liu
Conditions:
Hend and Neck Squamous Cell Carcinoma Locally Advanced Operable
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study is a single arm phase ll trial including 52 patients with T2N2-3M0#T3-4N0-3M0 (III-V) head and neck squamous cell carcinoma(HNSCC) eligible forresection, who receive Cetuximab+ Zimberelimab...
Detailed Description
In this study, eligible subject will be enrolled into study arm to accept study treatment objective response rate will be the primary outcome measures.
Eligibility Criteria
Inclusion
- Newly diagnosed primary head and neck squamous cell carcinoma confirmed by histology and/or cytology (excluding diagnostic therapy).
- Clinical stage:T2N2-3M0,T3-4N0-3M0 (AJCC 8th editionstaging).
- Age: 18 to 70 years.
- PS score (see Appendix Table 1; performance status score of 0 or 1).
- Patients evaluated by a head and neck oncologist as resectable with no distant metastases.
- Patients with at least one measurable lesion according to RECIST version 1.1 criteria.
- Patients' toxicities assessed according to CTCAE version 4.03 criteria.
- Patients with normal organ function (heart,brain, lungs, kidneys) and suitable for surgery:
- Hematology: White blood cells ≥ 3500/μL,neutrophils ≥1,800/pL, hemoglobin ≥ 9 g/dL, platelets ≥100,000/μL;
- Liver function: Bilirubin ≤ 1.5 times the upper limit of normal (ULN) (patients with known Gilbert's disease and serum bilirubin levels ≤ 3 times ULN can be included), AST and ALT ≤3 times ULN, alkaline phosphatase ≤ 3 times ULN; albumin ≥ 3 g/dL; c.Renal function: Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min according to Cockcroft-Gault formula.
- Patients have signed an informed consent form, are willing and able to comply with the study's visit, treatment plan, laboratory tests, and other study procedures.
Exclusion
- History of severe hypersensitivity reactions to components of other monoclonal antibodies, CTLA4, or PD-1 antibodies.
- Patients with known or suspected autoimmune diseases, including dementia and epileptic seizures.
- Recurrence, distant metastasis, or the inability to undergo surgery as assessed by a head and neck physician.
- Abnormal coagulation function:(PT \> 16s,APTT\>53s,TT\> 21s, Fib \< 1.5g/L), bleeding tendency, or currently on anticoagulant or thrombolytic therapy.
- Severe heart disease, pulmonary dysfunction, patients with heart or lung function below Grade 3 (including Grade 3).
- Laboratory values not meeting relevant criteria within 7 days prior to enrollment.
- Previous use of anti-PD-1 antibodies, anti-PD-L1 antibodies,anti-PD-L2 antibodies, or anti-CTLA-4 antibodies (or any other antibodies targeting T cell co-stimulation or checkpoint pathways).
- Pre-existing conditions requiring long-term use of immunosuppressive drugs or a need for systemic or local use of corticosteroids at immunosuppressive doses prior to enrollment.
- HIV-positive individuals;HBsAg-positive individuals with positive HBV DNA copy number (quantitative test≥1000 cps/ml); positive chronic hepatitis C blood screening(HCV antibody positive).
- Traditional herbal medicine used for anti-tumor purposes within 4 weeks before randomization.
- Women of childbearing potential with a positive pregnancy test and breastfeeding women.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06107114
Start Date
December 1 2023
End Date
December 1 2024
Last Update
November 22 2023
Active Locations (1)
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1
Sun Yat-sen University
Guangzhou, Guangdong, China