head and neck squamous cell carcinoma
Conditions
Interventions
Case series:Gemcitabine combined with nedaplatin for simultaneous radiochemotherapy
Sponsors
Tianjin Union Medical Centre
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) confirmed recurrent or locally advanced head and neck squamous cell carcinoma by histology; (2) no previous treatment with GEM; (3) aged 18-70 years; (4) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; (5) at least one measurable lesion by the RECIST 1.1 criteria; (6) no other active malignancies; (7) previous organ-sparing surgery allowed; (8) life expectancy of at least 3 months, with adequate bone marrow and normal organ function (renal, heart and hepatic function); (9) at least 4 weeks in treatment-free interval; (10) at least one year since the last radiotherapy; (11) no other distant organ metastasis; (12) no other serious medical complications; (13) provision of written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with distant metastasis; 2. There are serious uncontrolled medical diseases, such as complicated medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, uncontrolled infection, active peptic ulcer, etc.; 3. There is dementia, a change in mental state, or any mental illness that would hinder understanding or make informed consent or fill out a questionnaire; 4. history of allergy or hypersensitivity to any therapeutic ingredient; 5. Malignant tumors other than head and neck squamous cell carcinoma in the past 5 years, in addition to fully treated basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and ductal carcinoma in situ after radical resection; 6. Abnormal results of physical examination and laboratory examination: (1) Hematological abnormalities are defined as: 1) Absolute neutrophil (ANC) count: 1.5 ULN; 2) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels> 2.5 ULN, and if liver metastases exist, >5 ULN; 3) Definition of abnormal renal function:Serum creatinine> 1.5 ULN, or calculated creatinine clearance <50ml/min; 7. Those who need to combine other anti-tumor drugs; 8. Have received any other experimental drug treatment or participated in another interventional clinical trial within 30 days before screening; 9. The researchers think it is not suitable for enrollment; 10. Women who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;disease control rate;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;overall survival; | — |
Countries
China
Contacts
Public ContactWANG FENGWEI
Tianjin Union Medical Centre
Outcome results
None listed