This trial aims to evaluate whether the addition of anti-PD-1 antibody to adjuvant postoperative chemoradiotherapy could improve disease free survival in patients with high-risk locally advanced head and neck squamous cell carcinoma (HNSCC).
This open-label, randomized, controlled, phase II study will include 173 patients who have been operated for their LA SCCHN with high risk. Subjects will be randomized (1:1) to receive post-operative concomitant cisplatin-RT followed by/not PD-1 antibody. The study is designed with the general objective of demonstrating that treatment CCRT followed by PD-1 antibody is more efficient than CCRT alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
173
Postoperative CCRT followed by any anti-PD-1 monoclonal antibody of the following: Pembrolizumab, 200mg, Q3W or Nivolumab, 3mg/kg, Q2W or Tislelizumab,200mg,Q3W or Camrelizumab,200mg,Q3W or Sintilimab,200mg,Q3W or Toripalimab,240mg,Q3W
Postoperative chemoradiotherapy
National Cancer Cencer/Cancer hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
RECRUITINGDisease free survival at year 2 (2y-DFS)
Disease-free survival time is defined as the time from date of randomization until the first disease recurrence(including carcinoma in situ)or death from any cause.
Time frame: From randomization until time of events up to 2 years
Locoregional control at year 2 (2y-LRC)
LRC defined from randomization to first radiographically or pathologically confirmed local or regional recurrence.
Time frame: From randomization until time of events up to 2 years
Overall survival at year 2 (2y-OS)
Time between the date of randomization and death.
Time frame: From randomization until death due to any cause, up to 2 years
Adverse events
Adverse events and serious adverse events according to CACTE 5.0.
Time frame: From randomization until time of events up to 2 years
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