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This is a prospective, open-labelled study to evaluate the efficacy and safety of camrelizumab combined with apatinib mesylate in the induction treatment of patients with locally advanced head and neck squamous cell carcinoma who were judged surgically unresectable or appropriate for non-surgical definitive therapy. The objective response rate (ORR) and safety will be evaluated as the primary endpoints, the 2-year overall survival (OS) rate and progression free survival (PFS) rate will be the second endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Inductive therapy with Camrelizumab and Apatinib |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | 200mg, iv, on day 1, 15, 29, 43 |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (CR+PR) | Objective Response Rate as defined by RECIST 1.1 after induction therapy followed by definitive chemoradiation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Grade 3-4 Toxicity | Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 | 9 weeks |
| Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guopei Zhu, M.D. | Contact | 021-23271699 | 5665 | antica@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Recruiting | Shanghai | Shanghai Municipality | 200011 | China |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
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| Apatinib Mesylate | Drug | 250 mg po, qd, 28 days as a cycle, 2 cycles in total |
|
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Time to death or progression defined by imaging of target lesions via CT or MRI scan every 3 months
| 2 years |
| Progression-Free Survival | Time to death or progression defined by imaging of target lesions via CT or MRI scan every 3 months | 2 years |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |