Head and Neck Cancer, PD-1, Radiation
Conditions
Brief summary
To investigate whether concurrent Tislelizumab with postoperative chemoradiotherapy would have survival benefit in high Risk HNSCC Patients.
Interventions
DRUGTislelizumab
Tislelizumab 200mg q3w
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed squamous cell carcinoma of the head and neck. Site of tumor origin in the oral cavity, oropharynx (p16-), larynx, or hypopharynx 2. With at least one high risk factor after radical surgery ①positive margin; ②close margin（\<5mm); ③ENE. 3. No distant metastases 4. No synchronous or concurrent head and neck primary tumors 5. ECOG PS 0-1 6. Adequate organ function including the following: Absolute neutrophil count (ANC) \>= 1.5 \* 10\^9/l Platelets count \>= 80 \* 10\^9/l Hemoglobin \>= 80 g/dl AST and ALT \<= 2.5 times institutional upper limit of normal (ULN) Total bilirubin \<= 1.5 times institutional ULN Creatinine clearance \>30 ml/min 8. Signed written informed consent
Exclusion criteria
1. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region 2. Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma 3. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures 4. Uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia 5. Active, known or suspected autoimmune disease such as interstitial pneumonia, uveitis, Crohn's disease, autoimmune thyroiditis. Subjects with cured childhood asthma, type I diabetes mellitus and hypothyroidism only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment 6. Using systemic immunosuppressive agents and continue the dose within 2 weeks prior to the enrollment;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-year disease free survival | 1 year | from date of enrollment until date of first documented disease progression or from date of enrollment until date of first documented disease progression or death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 2 years | from date of enrollment until death from any cause |
| Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v4.0 during the course of treatment | up to 3 months after completion of radiotherapy | Acute toxicity profiles, graded according to the NCI CTCAE version 4.0 |
Outcome results
None listed