Overview

Recombinant Human Endostatin Adenovirus Combined With Chemotherapy for Advanced Head and Neck Malignant Tumors

Status:
Unknown status
Trial end date:
2016-10-01
Target enrollment:
0
Participant gender:
All
Summary
This study will investigate the efficacy and safety of recombinant human endostatin adenovirus combined with chemotherapy for advanced head and neck malignant tumors.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Renmiao Zhang
Collaborator:
West China Hospital
Treatments:
Albumin-Bound Paclitaxel
Cisplatin
Endostatins
Paclitaxel
Criteria
Inclusion Criteria:

- Advanced head and neck cancer unsuitable for surgery or radiotherapy (including head
and neck squamous carcinoma and nasopharyngeal carcinoma, which should not more than
30%)

- Cytological and/or histopathologic diagnosis

- Target lesions can be treated with intratumor injection

- Lesions can be measured by imaging with a diameter of ≥2 cm (RECIST1.1)

- No chemotherapy, radiotherapy, or biotherapy administered in the past 4 weeks

- Age of 18 to 70 years

- Life expectation of ≥12 weeks

- ECOG performance status of 0 to 2

- Laboratory examinations performed ≤7 days before enrollment with the following
results: absolute neutrophil count of ≥1.5 × 109 L-1, platelet count of ≥80 × 109/L,
total bilirubin level of ≤2 mg/dL, AST and ALT levels of ≤2 times the upper limit of
the reference range, and coagulation parameters ≤1.5 times the upper limit of the
reference range

- Voluntary participation and written informed consent

Exclusion Criteria:

- Allergy to EDS01

- Nerves and vessels passing through target lesions do not allow for injection of EDS01
into lesions

- Simultaneous radiation of target lesions

- Cancer recurrence within 6 months treated by paclitaxel

- Severe coagulation dysfunction and bleeding tendency

- Serious medical diseases, myocardial infraction in the past 3 months, or acute
infection

- Currently pregnant or lactating

- Any conditions that the investigator regards as unsuitable for the study