This study is looking to see if sintilimab, an anti-PD-1 McAb given with cisplatinum and paclitaxel (2 chemotherapy agents) during induction therapy in advanced head and neck squamous cell carcinoma can significantly shrink the subject's cancer, then de-escalation radiotherapy can be used.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Radiotherapy: de-escalation radiotherapy or standard radiotherapy
Hubei Cancer Hospital
Wuhan, Hubei, China
RECRUITINGPathological complete response rate (pCR)
pCR was defined as the absence of histologically identifiable residual cancer in any resected specimen. The objective is to intensify induction chemotherapy with the addition of anti-PD-1 McAb sintilimab aimed at acquiring a higher postoperative pCR.
Time frame: 3 weeks
Radiation dose of normal organs and treatment-related adverse events
Assess the radiation dose of normal organs between the de-escalation radiotherapy group or standard radiotherapy group. Furthermore, toxicities reaction between two groups also been compared. Adverse events were any untoward medical occurrence in a participant who received study interventions without regard to possibility of causal relationship.
Time frame: 12 months
Safety of sintilimab in combination with chemotherapy
Evaluate the safety of sintilimab in combination with chemotherapy followed by surgery and radiotherapy in advanced head and neck squamous cell carcinoma patients.
Time frame: 12 months
Functional assessment of cancer therapy scale head and neck quality of life assessments
Evaluate quality of life in all patients. The specific modules H\&N35 in Quality of Life Questionnaire Core 30 module (QLQ-C30) and European Organization for Research and Treatment of Cancer (EORTC) and Functional Assessment of Cancer Therapy (FACT) H\&N V4.0 were used. Both of them are standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score.
Time frame: 6 months after the use of anti-PD-1 McAb sintilimab
Progression free survival (PFS) in 2 years
PFS was defined as the time from the date of randomization to the first documentation of objective progressive disease (PD) per modified RECIST v1.1 as assessed by Investigator or death (due to any cause), whichever occurred first. Comparing the PFS at 24 months after completing chemotherapy, surgery, and radiotherapy between arm 1 and arm 2.
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Time frame: 24 months