E10A for the Treatment of Squamous Cell Carcinoma of the Head and Neck

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Recombinant human endostatin adenovirus injection is a novel anti-tumor gene therapy drug. E10A contains a recombinant human endostatin gene with the second-generation recombinant adenovirus as its vector. After transfection tumor cells. E10A expresses human endostatin, which inhibits vascular endothelial cell proliferation and tumor angiogenesis, and blocks tumor blood supply, thereby specifically inhibiting tumor growth and inducing apoposis of tumor cells. Both pre-clinical and animal models have demonstrated the anti-tumor activities of E10A. The safety and efficacy of E10A in treating head and neck cancer has also been demonstrated in Phase I and Phase II studies.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangzhou Double Bioproducts Co., Ltd
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Endostatins; Paclitaxel

Criteria

Inclusion Criteria:

1. Patients older than 18 years with histologically or cytologically proven locoregionally advanced or metastatic HNSCC (excluding NPC) not suitable for operation or radiotherapy

2. A life expectancy≧12 weeks.

3. Patients were required to have at least one measurable (by imaging or photograph complied RECIST) lesion with the largest diameter ≧2 cm and suitable for the intratumoral injection of E10A,

4. Not received chemotherapy, radiotherapy, or biotherapy within 4 weeks.

5. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-2.

6. Adequate bone marrow,renal, and liver functions.

Exclusion Criteria:

1. Known allergies to the study drug.

2. The presence of important blood vessels/nerves or ulceration in the target lesion not suitable for injection.

3. Tumor relapses within 6 months after paclitaxel chemotherapy.

4. Severe coagulation disorders or bleeding tendency.

5. Severe uncontrolled medical conditions.

6. Recent history of myocardial infarction acute infection, pregnancy or lactation, or symptomatic brain metastases

7. A history of corticosteroids or immunosuppressives use within four weeks of study entry

8. Received any chemotherapy or radiotherapy within four weeks of study entry