Cervical metastasis lymph nodes of advanced head and neck cancer
Conditions
Interventions
Experimental group 1:1.0E11vp/unit dose of recombinant human endostatin adenovirus injection, 1-3 unit doses according to tumor volume
paclitaxel / cisplatin is the basic chemotherapy plan. Chemotherapy regimen: Paclitaxel 160mg / m2, D1, cisplatin 25mg / m2, D1, D2, D3, every three weeks for a treatment cycle.
Experimental group 2:Recombinant human endostatin adenovirus injection 3.0E11vp/unit dose, 1-3 unit doses according to tumor volume
control group:Paclitaxel / cisplatin chemotherapy:Paclitaxel 160mg / m2, D1 administration, cisplatin 25mg / m2, D1, D2, D3 administration, every three weeks for a treatment cycle.
Sponsors
Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. Advanced head and neck cancer, including head and neck squamous cell carcinoma and nasopharyngeal carcinoma, confirmed by histology or cytology and not suitable for radiotherapy and operation, the target focus is limited to the recurrence of lymph nodes after radiotherapy and chemotherapy or operation; 3. According to the RECIST standard, there is at least one measurable body surface lesion suitable for intratumoral injection (with spiral CT / MRI, the diameter of the lesion >= 10 mm, and spiral CT with thin-layer scanning = 1.5 x 10^9 / L, platelet (PLT) >= 80 x 10^9 / L, TBI = 3 months; 7. ECOG physical state score 0-2; 8. The patient voluntarily participated in the trial and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. There are still any unsolved toxic reactions of CTCAE Level 2 or above caused by previous anticancer treatment; 2. Patients with target lesions involving skin or lesions involving important blood vessels not suitable for local injection; 3. Relapse within half a year after paclitaxel chemotherapy; 4. Combined with significant liver, kidney, heart, nerve, mental and other important organ diseases or dysfunction, such as having known poorly controlled diabetes, poorly controlled hypertension, liver failure, unstable angina, 6 months Internal myocardial infarction, New York Heart Association grade III or IV congestive heart failure, history of cerebrovascular accident within 6 months, history of severe neurological or mental illness, etc .; active severe clinical infection (CTCAE grade 3 or above) By; 5. Severe coagulation mechanism disorder and bleeding tendency; 6. Have a history of organ transplantation, or have other acquired, innate immune system disorders; 7. People using antiviral drugs; 8. People who may be allergic to test drug ingredients, cisplatin or paclitaxel; 9. Pregnant or lactating women, or pregnant planners; 10. Currently or recently (within 28 days before randomization) received other experimental drugs or participated in other research trials; 11. Other unsuitable participants according to the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete cytoreduction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum endostatin;Anti adenovirus antibody;Anti endostatin antibody;Neutralizing antibody titer;Microvascular density count;Expression of human endostatin; | — |
Countries
China
Contacts
Public ContactGuo Wei
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of medicine
Outcome results
None listed