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The goal of this study is to determine the efficacy and safety of camrelizumab given concomitantly with chemoradiation in participants with unresectable, locally advanced head and neck squamous cell carcinoma (LA-HNSCC). All participants will receive camrelizumab in addition to chemoradiation, the standard treatment for LA-HNSCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Arm | Experimental | Camrelizumab every 2 weeks in combination with 6-7 weeks of radiation therapy and every 3 weeks cisplatin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Biological | Administered as an intravenous (IV) infusion every 2 weeks (Q2W): 14 days prior to radiation, then Day 1 of radiation and then every 14 days for total 8 doses. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | The number of participants with radiologically confrmed complete or partial response according to RECIST 1.1 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is the time from randomization to death due to any cause. | Up to 5 years |
| Disease-free Survival (DFS) | DFS is the time from the date of randomization to the date of first record of disease recurrence or death. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Li, MD, PhD | Contact | 18980606806 | yy1240@163.com | |
| Xingchen Peng, MD,PhD | Contact | 18980606753 | pxx2014@scu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yan Li, MD,PhD | West China Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D002945 | Cisplatin |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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|
| Cisplatin | Drug | 75-100 mg/m^2 administered as an IV infusion Q3W, for a total of 3 doses, at the same time as radiation: Day 1, Day 22, Day 43 of radiation. |
|
|
| IMRT or VMAT | Radiation | 66-70 Gy given in 33-35 fractions over 6-7 weeks. |
|
| Up to 5 years |
| Acute Adverse Events (AEs) | The number of participants who experience unacceptable toxicity during protocol treatment as measured by the NCI CTCAE version 4.0 | Up to 6 months |
| D009370 |
| Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
| D020266 |
| Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |