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 Camrelizumab combined with cisplatin and Nab-paclitaxel. This proposed study will evaluate the efficacy and safety of preoperative administration of Camrelizumab combined with chemotherapy in Head and Neck Squamous Cell Carcinoma (HNSCC) who are about to undergo surgery.
In this study, eligible subject will be enrolled into study arm to accept study treatment. Objective response rate will be the primary outcome measures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Patients receive Camrelizumab IV on day 1, nab-paclitaxel IV on day 1 and cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGORR
overall response rate
Time frame: 9 weeks
pCR
Pathological Complete Response
Time frame: 9 weeks
MPR
Major Pathological Response
Time frame: 9 weeks
DCR
Disease Control Rate
Time frame: 9 weeks
PFS
Progression-free survival
Time frame: 2 years
OS
overall survival
Time frame: 5 years
Adverse events graded by CTCAE v5.0
Percentage of adverse events that are possibly, probably or definitely related to study treatment per Criteria for Adverse Events version 5 (CTCAE v5.0).
Time frame: 90 days after the first dose of study treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.