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| Name | Class |
|---|---|
| Fudan University | OTHER |
| Eye & ENT Hospital of Fudan University | OTHER |
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
| First Affiliated Hospital of Fujian Medical University |
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To investigate weather concurrent JS001 with postoperative radiotherapy would have survival benefit in intermediate/high Risk HNSCC Patients who cannot take cisplatin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| concurrent PD-1 | Experimental | Concurrent Immunotherapy With Postoperative Radiotherapy |
|
| Radiotherapy alone | Active Comparator | Postoperative Radiotherapy alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| postoperative radiotherapy | Radiation | postoperative radiotherapy with a dose of 60-66Gy |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Acute toxicity profiles, graded according to the NCI CTCAE version 4.0 |
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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:
①Age>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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shengjin Dou | Contact | 15800386875 | doushengjin@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guopei Zhu | Recruiting | Shanghai | 200011 | China |
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| OTHER |
| Guizhou Provincial People's Hospital | OTHER |
| Central South University | OTHER |
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| JS001 | Drug | JS001 240mg every three week |
|
|
| up to 3 months after completion of radiotherapy |
| Number of participants with treatment-related late toxicity as assessed by CTCAE v4.0 | Late toxicity profiles, graded according to the NCI CTCAE version 4.0 | from 3 months after completion of radiotherapy up to 2 years |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
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