Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
Head and neck cancer, radiotherapy, PD-1
Brief summary
To investigate weather concurrent JS001 with postoperative radiotherapy would have survival benefit in intermediate/high Risk HNSCC Patients who cannot take cisplatin
Interventions
RADIATIONpostoperative radiotherapy
postoperative radiotherapy with a dose of 60-66Gy
DRUGJS001
JS001 240mg every three week
Sponsors
Fudan University
Eye & ENT Hospital of Fudan University
Tianjin Medical University Cancer Institute and Hospital
First Affiliated Hospital of Fujian Medical University
Guizhou Provincial People's Hospital
Central South University
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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, larynx, hypopharynx , or sinuses (excluding nasopharynx) 2. With at least one risk factors after radical surgery ①positive margin; ②close margin（\<5mm); ③ENE;④PNI;⑤LVI; ⑤ pT3-4/N2-3( AJCC 8th).⑥ Level IV/V lymph node metastases for OPC or OC. 3\. Have at least one contraindication to cisplatin as defined: ① Age\>65 years old; ②Creatinine clearance (CC) \> 30 and \< 60 cc/min For this calculation, use the Cockroft-Gault formula: CC = 0.85 (if female)\* ((140-Age) / (Serum Creatinine)) \* (Weight in kg / 72); ③ Zubrod performance status 2; ④Pre-existing peripheral neuropathy grade ≥ 1; ⑤History of hearing loss, defined as either: ▪ Existing need of a hearing aid OR ≥ 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated. 4\. No distant metastases 5. No synchronous or concurrent head and neck primary tumors 6. ECOG PS 0-2 7. Adequate organ function including the following: 1. Absolute neutrophil count (ANC) \>= 1.5 \* 10\^9/l 2. Platelets count \>= 80 \* 10\^9/l 3. Hemoglobin \>= 80 g/dl 4. AST and ALT \<= 2.5 times institutional upper limit of normal (ULN) 5. Total bilirubin \<= 1.5 times institutional ULN 6. 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 |
|---|---|
| Disease free survival | from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | from date of enrollment until death from any cause, assessed up to 2 years | — |
| 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 |
| Number of participants with treatment-related late toxicity as assessed by CTCAE v4.0 | from 3 months after completion of radiotherapy up to 2 years | Late toxicity profiles, graded according to the NCI CTCAE version 4.0 |
Countries
China
Contacts
Primary ContactShengjin Dou
Outcome results
None listed