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.
Name: Endostatins
Name: Paclitaxel injection
Name: Cisplatin injection
Description: Time to progression is defined as the time from randomization until objective tumor progression as verified for the first time
Measure: Time to progression Time: Up to 24 weeksDescription: the end of every 2 treatment cycles (each cycle is 21 days), and every 3 months during follow-up until disease progression. objective response rate (RR), defined as the proportion of patients who had a complete response (CR) or partial response (PR) at the target tumor lesion.
Measure: Change in Overall response rate (CR+PR) Time: Up to 24 weeks, from date of randomization until the date of first documented progressionDescription: the end of every 2 treatment cycles(each cycle is 21 days), and every 3 months during follow-up until disease progression.The CR or PR patients were reconfirmed
Measure: Chang in disease control rate (CR+PR+SD) Time: Up to 24 weeks, From date of randomization until the date of first documented progressionDescription: All adverse events were recorded regardless of their relevance to E10A
Measure: Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) Time: Up to 32 weeks, from date of randomization until the date of first documented progression or dateDescription: from cycle 2 to cycle 4 and calculated the survival during follow-up
Measure: Overall survival Time: Up to 24 month, through study completionAllocation: Randomized
Parallel Assignment
There is one SNP
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. --- E10A ---
E10A for the Treatment of Squamous Cell Carcinoma of the Head and Neck Recombinant human endostatin adenovirus injection is a novel anti-tumor gene therapy drug. --- E10A ---
E10A contains a recombinant human endostatin gene with the second-generation recombinant adenovirus as its vector. --- E10A ---
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. --- E10A ---
Both pre-clinical and animal models have demonstrated the anti-tumor activities of E10A. --- E10A ---
The safety and efficacy of E10A in treating head and neck cancer has also been demonstrated in Phase I and Phase II studies. --- E10A ---
All adverse events were recorded regardless of their relevance to E10A. --- E10A ---
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. --- E10A ---
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 Head and Neck Neoplasms Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck Head and Neck Neoplasms Phase II Clinical Study From March 2008 to December 2010 Safety and efficacy of intratumoral injections of E10A to cisplatin and paclitaxel was evaluated a multicenter, open-label, randomized clinical study in patients with advanced head and neck squamous cell carcinoma. --- E10A ---
Patients with locally advanced or metastatic head and neck squamous cell carcinoma or nasopharyngeal carcinoma not suitable for operation or radiotherapy were randomly assigned to receive E10A plus chemotherapy every 21 for a maximum of six cycles or to receive chemotherapy only. --- E10A ---
The administration of E10A benefited some subgroups of patients. --- E10A ---
In the HNSCC patients, the objective RR was 36.5% (15/41) with E10A administration, exhibiting a trend of exceeding the rate of 20.0% (7/35) in the control group (P = 0.090; OR: 0.43), whereas the objective RR was 44.4% (12/27) versus 40.6% (13/32) in the NPC patients (P = 0.487; OR: 0.86). --- E10A ---
Patients who had previously received chemotherapy in the E10A group had a 44.8% (12/29) objective RR, whereas patients in the control group had only a 22.6% objective RR (7/31; P = 0.06, OR: 0.36). --- E10A ---
The difference in the Kaplan-Meier estimates of PFS favored chemotherapy plus E10A, which resulted in a 3.43-month improvement. --- E10A ---
in the E10A group. --- E10A ---
The OS of the E10A group was relatively prolonged in different subgroups compared with the controls (e.g., 13.37 months versus 9.67 months in the HNSCC patients, 13.03 months versus 10.50 months in those who had received prior treatment; Figure 1), but these results did not translate into significantly superior survival. --- E10A ---