Clinical trial · Interventional
E10A for the Treatment of Squamous Cell Carcinoma of the Head and Neck
A Randomized, Open-label, Multi-center Phase III Study Designed to Evaluate the Safety and Efficacy of E10A in Patients With Recurrent/Unresectable Squamous Cell Carcinoma of the Head and Neck Region
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin injection | Drug | Cisplatin | ALIAS |
| Endostatins | Drug | — | UNRESOLVED |
| Paclitaxel injection | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Combination therapy
- description
- E10A+chemotherapy group (360 subjects): 1. E10A (Endostatins) of 1.0×1012VP on day 1 and 6 2. Paclitaxel Injection 160mg/m2 on day 3 3. Cisplatin Injection 25mg/m2 on day 3, 4, and 5. Repeat every 21 days.
- interventionNames
- Drug: Endostatins
- Drug: Paclitaxel injection
- Drug: Cisplatin injection
- type
- EXPERIMENTAL
- label
- Chemotherapy
- description
- Chemotherapy-alone group (180 subjects): 1. Paclitaxel Injection 160mg/m2 on day 1 2. Cisplatin Injection 25mg/m2 on day 1, 2, and 3. Repeat every 21 days
- interventionNames
- Drug: Paclitaxel injection
- Drug: Cisplatin injection
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTYe W, Liu R, Pan C, Jiang W, Zhang L, Guan Z, Wu J, Ying X, Li L, Li S, Tan W, Zeng M, Kang T, Liu Q, Thomas GR, Huang M, Deng W, Huang W. Multicenter randomized phase 2 clinical trial of a recombinant human endostatin adenovirus in patients with advanced head and neck carcinoma. Mol Ther. 2014 Jun;22(6):1221-1229. doi: 10.1038/mt.2014.53. Epub 2014 Mar 25. PMID 24662947
- RESULTLin X, Huang H, Li S, Li H, Li Y, Cao Y, Zhang D, Xia Y, Guo Y, Huang W, Jiang W. A phase I clinical trial of an adenovirus-mediated endostatin gene (E10A) in patients with solid tumors. Cancer Biol Ther. 2007 May;6(5):648-53. doi: 10.4161/cbt.6.5.4004. Epub 2007 Feb 13. PMID 17426445