Status:
RECRUITING
Neoadjuvant Camrelizumab in Combination With Cisplatin and Nab-paclitaxel in Resectable HNSCC
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study is a single arm phase II trial including 53 patients with T2N2-3M0、T3-4N0-3M0（III-IV） head and neck squamous cell carcinoma (HNSCC) eligible for resection, who receive neo-adjvuant Camreliz...
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
- Inclusion Criteria：
- Confirmed pathologic and/or cytologic diagnosis of squamous cell carcinoma of head and neck，T2N2-3M0、T3-4N0-3M0（III-IV）（AJCC 8.0）
- Greater than or equal to 18 and less than 65 years of age at time of study entry.
- ECOG performance status of 0 or 1.
- Resectable or potentially resectable lesion, without distance metastasis;
- Measurable disease as per RECIST 1.1.
- Screening labs must meet the following criteria and must be obtained within 14 days prior to registration:
- Adequate hepatic、cardiac、brain and renal function as demonstrated by 1) Hematology: WBC≥4000/μL、NE≥2.000/μL、HGB≥9 g/dL、PLT≥100000/μL； 2) Renal: Serum creatinine \< 1.5x ULN or CrCl \> 60mL/min (if using the Cockcroft-Gault formula below): 3) Hepatic: Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3 x ULN)；AST/ALT ≤ 3 x ULN and ALP≤3 x ULN；ALB≥3g / dL；
- Ability to understand and willingness to sign an IRB approved written informed consent document. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- Exclusion Criteria:
- Severe allergic reaction to any component of PD-1 monoclonal antibodies or other monoclonal antibodies.
- Active, known or suspected autoimmune disease, including dementia and epilepsy.
- Has had another known invasive malignancy or unresectable cancer.
- Coagulation dysfunction: (PT \> 16S, APTT \> 53s, TT \> 21s, FIB \< 1.5g / L), bleeding tendency or thrombolysis, anticoagulation treatment.
- Severe cardiac disease, lung dysfunction, heart function and lung function lower than grade 3 (≤3).
- Laboratory abnormality within 7 days before enrollment.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
- Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications before enrollment.
- Has a known history of Human Immunodeficiency Virus (HIV).
- Has a known history of Hepatitis B (defined as HBV DNA ≥1000 cps/mL is detected) or known active Hepatitis C virus (defined as: HCV antibody positive) infection.
- have received anti-tumor herbs within 4 weeks before randomization.
- Pregnant or nursing women.
Exclusion
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04826679
Start Date
April 1 2021
End Date
April 1 2026
Last Update
April 1 2021
Active Locations (1)
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1
Sun Yat-sen University
Guangzhou, Guangdong, China