Head and neck neoplasms
Conditions
Interventions
Test group:After radical treatment, ripley's single joint capecitabine maintenance treatment
Sponsors
Tumor Hospital Affiliated to Guizhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age of 18-75 years old; (2) confirmed by histology or cytology of head and neck squamous cell carcinomas; (3) locally advanced head and neck squamous cell carcinomas had postoperative radiotherapy or radical radiation and chemotherapy high risk patients with recurrence risk transfer (T4, N2c - 3) (according to the international union of cancer control (UICC) the eighth installment). (4) The residual lesions were not suitable for re-radical treatment (5) Bone marrow function: neutrophil > 1.5×10^9/L, hemoglobin > 90g/L and platelet count > 100×10^9/L. (6) Liver function: ALT (alanine aminotransferase, ALT), aspertate aminotransferase, aspartate aminotransferase, AST) 50 ml/min. (8) ECOG PS 1 or less. (9) signed and dated written informed consent in accordance with ICH-GCP and local legal requirements
Exclusion criteria
Exclusion criteria: (1) Interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy within the previous year; (2) receiving systemic sex hormone or other immunosuppressive therapy with an equivalent dose of > 10mg prednisone/day within 28 days before signing informed consent. Subjects with systemic hormone doses =10mg prednisone/day or inhaled/topical corticosteroids could be enrolled. (3) in addition to the full treatment of non melanoma skin cancer, cervical carcinoma in situ and thyroid papillary carcinoma, past or present with other malignant tumor; (4) in the first routine ripley single resistance within 30 days before the accept the vaccine; (5) has a history of organ transplantation, (6) during radiation therapy or surgery in patients undergoing biological therapy or immunotherapy; (7) are being or are likely to accept other patients with chemotherapy, biological therapy or immunotherapy; (8) to other monoclonal antibody has a history of severe allergic reactions; (9) radiotherapy history before standard treatment (except non-melanoma skin cancer). (10) can't stand or to any known drug susceptibility of the patients. Other conditions assessed by the investigator that could compromise patient safety or adherence, such as serious medical conditions requiring prompt treatment (including psychiatric conditions), severely abnormal test results, or other high family or social risk factors. (12) women who are pregnant or breastfeeding (pregnancy testing should be considered in sexually active women of childbearing age); (13), difficulty swallowing, chronic diarrhea interference or obstruction diseases of oral drugs. "(14) Active, known, or suspected autoimmune disease (including, but not limited to, uveitis, enteritis, hepatitis, pituitary disease, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilation)." Except for type 1 diabetes, need hormone replacement therapy hypothyroidism, and don't need systemic treatment of skin diseases (such as vitiligo, psoriasis, or hair loss); Clinicians should be carried out against the disease in the group of former necessary history, physical examination, inspection and examination shall be ruled out; (15) severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral therapy, including but not limited to tuberculosis infection, within 2 weeks before adjuvant therapy (16) hepatitis B surface antigen positive and hepatitis B virus quantification >1×10^3 copies/ml, or anti-hepatitis C virus antibody positive; (17) diagnosed HIV antibody positive or acquired immunodeficiency syndrome (AIDS); (18) not controlled heart disease, such as: 1) heart failure, NYHA level 2 or higher; 2) unstable angina; 3) history of myocardial infarction in the past year; 4) supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 years progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Distant metastasis-free survival; | — |
Countries
China
Contacts
Public ContactLi Yuanyuan
Guizhou medical university affiliated hospital
Outcome results
None listed