Status:
UNKNOWN
Recombinant Human Endostatin Adenovirus Combined With Chemotherapy for Advanced Head and Neck Malignant Tumors
Lead Sponsor:
Renmiao Zhang
Collaborating Sponsors:
West China Hospital
Conditions:
Head and Neck Neoplasms
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study will investigate the efficacy and safety of recombinant human endostatin adenovirus combined with chemotherapy for advanced head and neck malignant tumors.
Detailed Description
Head and neck cancer is one of the most common malignant tumors in China, accounting for 19.9% to 30.2% of malignant tumors in this country. Approximately 60% to 70% of patients have stage III or IV d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2016
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT02283489
Start Date
October 1 2014
End Date
October 1 2016
Last Update
November 5 2014
Active Locations (4)
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1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
2
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
3
Chongqing Cancer Hospital
Chongqing, China, 400030
4
Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University School of Medicine
Shanghai, China, 200011