Head and Neck Squamous Cell Carcinoma Clinical Trial
Official title:
A Single Center, Prospective, Randomized Controlled, Phase II Clinical Study of Anti-PD-1 Antibody js001 (Treprizumab) Combined With TP Neoadjuvant Chemotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma
The objective of research is to evaluate the efficacy and safety of treprizumab injection combined with AP regimen in the treatment of resectable locally advanced head and neck squamous cell carcinoma.122 patients were randomly divided into two groups: the test group (treprizumab injection combined with AP protocol) and the control group (TP protocol); The patients in both groups were treated with three cycles of induction therapy. After the induction therapy, the patients were evaluated and followed up with surgery.
The case report form shall be filled by the investigator, and each selected case must complete the case report form. The completed case report form is used for data entry and management. All original data were retained by the research department.Full analysis set: according to the principle of intention to analyze (ITT), all cases who received drug treatment and took drugs at least once were analyzed for efficacy. For the case data that cannot observe the whole treatment process, the last observation data shall be carried forward to the final results of the study (LOCF). Per-protocol set: all cases that comply with the study protocol, have good compliance, have not taken prohibited drugs during the study period, and have completed the contents specified in the case report form. No imputation was performed for missing data. Fas and PPS were analyzed statistically for the efficacy of the drug. Safety analysis set: all enrolled patients who have used the study drug at least once and have safety records after drug use belong to the safety analysis set. This data set was used for safety analysis. All statistical analysis will be calculated by SPSS statistical analysis software. All statistical tests are conducted by two-sided test. If the p value is less than or equal to 0.05, the difference tested will be considered statistically significant. The confidence interval is 95%. Baseline data were analyzed according to the full analysis set, and all efficacy indicators were analyzed according to the full analysis set and the compliance scheme set; The safety analysis set is adopted for the safety analysis. The sample size calculated by pass 11.0 software: according to the existing literature, the PCR rate of neoadjuvant treatment for advanced head and neck squamous cell carcinoma in our bureau is about 16%, and it is expected that the combined treatment with treprizumab will be increased to 40%, so P1 is set to 40%. α= 0.05， β= 0.2, the sample size was calculated using Simon optimal two stage designs for phase II clinical trial model, and the planned number of enrolled cases was 122. ;
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