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This is a non-randomized, phase II, open label study of apatinib mesylate tablets plus tegafur gimeracil oteracil potassium capsules induction chemotherapy in locally advanced squamous cell carcinoma of head and neck patients who were judged surgically unresectable or appropriate for non-surgical definitive therapy.The primary purpose of this study is to evaluate the efficacy of apatinib mesylate tablets plus tegafur gimeracil oteracil potassium capsules in locally advanced squamous cell carcinoma of head and neck
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Apatinib Mesylate Tablets and Tegafur Gimeracil Oteracil Potassium Capsules administered as a daily oral treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib Mesylate Tablets | Drug | 500 mg qd.p.o. every day for 21 days as a cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (CR+PR) | Objective Response Rate as defined by RECIST 1.1 after induction chemotherapy 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 |
| Progression Free Survival |
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Inclusion Criteria:
Histologically or cytologically confirmed SCCHN or poorly differentiated or undifferentiated cancer of the head and neck.
Measurable disease.
All primary sites are eligible excluding nasopharyngeal.
Surgically unresectable and/or refuse surgery; Note: surgical unresectability will be defined as the combination of the treating surgeon's judgment of unresectability plus one of the following objective criteria:
Encasement of tumor or nodes to the carotid artery or ¾ encasement of the carotid artery.
Involvement of prevertebral musculature Invasion of the bone of the skull base Need for glossectomy or extensive glossal resection where functional outcome is considered unacceptable to surgeon or patient Involvement of the cervical spine Severe, unacceptable functional deficit that would result from any proposed definitive surgical resection.
ECOG performance status 0-1
Age > or = 18 years. Men and women are eligible for participation.
Must have acceptable organ and marrow function as defined below. Laboratory tests should be completed within 14 days prior to registration:
Absolute Neutrophil Count (ANC) > or = 1,500/mm3 Platelets > or = 100,000/mm3 Hemoglobin (Hgb) > 9g/dL Total bilirubin < or = 1.5mg/dL Albumin > 2.5 g/dL Aspartate aminotransferase (AST)/Alanine Aminotransferase (ALT) < or = 2.5 times institutional upper limit of normal, alkaline phosphatase < 2.5 x upper limit of normal, glomerular filtration rate (GFR) > 30 mL/min (by standard Cockcroft and Gault formula or measured via 24 hour urine collection)
Patients must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai ninth people's hospital | Shanghai | Shanghai Municipality | 200011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37251944 | Background | Jiang W, Li R, Zhang L, Dou S, Ye L, Shao Z, Wu S, Dong M, Li J, Zhu G. Efficacy and feasibility of Apatinib and S-1 as a novel oral induction therapy in locally advanced head and neck squamous cell carcinoma: an exploratory phase 2 open-label, single-arm trial. Front Oncol. 2023 May 12;13:1072538. doi: 10.3389/fonc.2023.1072538. eCollection 2023. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Tegafur Gimeracil Oteracil Potassium Capsules | Drug | 25mg/㎡ bid p.o. every day for 14 days as a cycle |
|
|
Rate of Progression Free Survival (Time to death or progression defined by imaging of target lesions via CT or MRI scan post induction chemotherapy and chemoradiotherapy)
| 3 years |
| Overall Survival | Rate of Progression Free Survival (Time to death post induction chemotherapy and chemoradiotherapy) | 3 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 |
|---|---|
| C553458 | apatinib |
| C079198 | S 1 (combination) |
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