This is a phase 2, single-arm clinical trial, with the purpose to evaluate the therapeutic efficacy and safety of PD-1 Blockade camrelizumab combined with induction chemotherapy followed by concurrent chemoradiotherapy and as adjuvant monotherapy in patients with locally advanced head and neck squamous cell carcinoma.
All participants from 3 hospitals will receive induction camrelizumab therapy at least one cycle (every 3 weeks) followed by definitive concurrent chemoradiotherapy. After 4\~6 weeks of the completion of radiotherapy, adjuvant camrelizumab therapy will begin every 3 weeks for 16 cycles (1 year) or continue until progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
200 mg, intravenous infusion over 30 minutes (Q3W); 1\~3 cycles of camrelizumab before radiotherapy and camrelizumab are maintained for 16 cycles (1 year) after the end of radiotherapy.
cisplatin is given at a dose of 40 mg/m2 via intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy every week for 6 cycles.
70 Gy/ 35 fractions/7 weeks, 5 fractions/week, 1 fraction/day.
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGChongqing University Three Gorges Hospital
Wanzhou, Chongqing Municipality, China
RECRUITINGThe Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
RECRUITINGEFFICACY Progress-free survival (PFS)
Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.
Time frame: 2 years
EFFICACY Overall survival (OS)
Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive.
Time frame: 2 years
EFFICACY Objective response rate (ORR)
Defined as a complete response (CR) or partial response (PR) from enrolled until disease progression or death due to any cause.
Time frame: 2 years
EFFICACY Duration of response (DOR)
Defined as the time from the first assessment of CR or PR to the first assessment of disease progression or death due to any cause.
Time frame: 2 years
SAFETY Incidence rate of adverse events (AEs)
Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs, according to the Common Terminology Criteria for Adverse Events, version 5.0.
Time frame: 2 years
QUALITY OF LIFE Quality of life (QoL): questionnaire
QoL is evaluated with the use of the head-and-neck-specific module (H\&N35) of the Quality of Life Questionnaire-Core 30 module (QLQ-C30).
Time frame: 2 years
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