treatment of recurrent / metastatic head and neck squamous cell carcinoma
Conditions
Interventions
Sponsors
Cancer Center,Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically or cytological confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, which has recurred/metastasised and is not amenable for salvage surgery or radiotherapy; 2. Documented progressive disease based on investigators assessment according toResponse Evaluation Criteria in Solid Tumours (RECIST) following receipt of a Systemic chemotherapy; 3. Measurable disease according to RECIST (version 1.1); 4. ECOG performance status 0 or 1 or 2 at the time of randomization visit.
Exclusion criteria
Exclusion criteria: 1. Hypertensive patients whose blood pressure can not be reduced to the normal range with antihypertensive drug therapy (systolic blood pressure> 140 mmHg diastolic blood pressure> 90 mmHg), the patients with grade 1 or above coronary heart disease, grade I arrhythmia (including QTc prolonged male> 450 ms, female> 470 ms) and grade I cardiac insufficiency; 2. Particular attentionPatients with gastrointestinal bleeding risk cannot be admitted; 3. The patients with coagulation dysfunction (INR>1.5×ULNAPTT>1.5×ULN), or bleeding tendency; 4. The patients with central nervous system metastasis; 5. Patients with nasopharyngeal carcinoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS, ORR, DCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life; | — |
Contacts
Public ContactKunyu Yang
Cancer Center,Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed