Advanced head and neck malignant tumors (including the head and neck squamous carcinoma and nasopharyngeal carcinoma)
Conditions
Interventions
The experimental group1:EDS 01 (1.0E11vp)
The experimental group2:EDS 01 (5.0E11vp)
The experimental group3:EDS 01 (1.0E12vp)
The experimental group4:EDS 01 (1.0E12vp)
Sponsors
West China Hospital, Sichuan university
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Histological or cytological proven head and neck cancer, and there are parts of the lesion surface, suitable for intratumoral injection; 2. Subjects should be an effective treatment for those who lack conventional, or by conventional therapies fail or relapse, or the patient firmly rejected the existing conventional therapy; 3. To be aged between 18 years and 65 years; 4. the expected lifetime of longer than three monthes; 5. ECOG score <=2 (ECOG physical grading standards see Annex 1); 6. major organs, such as heart, lung, liver, kidney function in normal condition; 7. 4 weeks did not receive systemic chemotherapy, radiotherapy, biological therapy, medical treatment or other medication studies, toxicity and treatment generated from the original recovery; 8. to fully understand the present study, written informed consent can cooperation adverse events and efficacy, patients or their legal representatives in writing to observe.
Exclusion criteria
Exclusion criteria: Exclusion criteria (in accordance with any of the following items 1) intracranial tumor metastasis; 2) chronic liver dysfunction or cirrhosis with coagulopathy; 3) associated with severe cardiopulmonary disease and other vital organs, can not tolerate treatment 4) white blood cell count 2.5*ULN or bilirubin>1.5*ULN; 6) Blood urea nitrogen (BUN)>2*ULN, or serum creatinine (Cr)>1.5mg/dl; 7) can significantly affect the clinical trials clinically active infection; 8) The combined immunodeficiency disease or a history of organ transplantation. For various reasons, need to take immunosuppressive drugs during 9) therapy or within 4 weeks of high-dose corticosteroids use; Use of antiviral drugs during the 10) treatment; 11) other drugs have serious allergies; 12) during pregnancy or breast-feeding women; 13) any clinical problem can not control (such as severe mental illness, neurological, cardiovascular, respiratory and other diseases).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation EDS01 safety and tolerability; | — |
Countries
China
Contacts
Public ContactYang Li
Outcome results
None listed