NCT02630264

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
540

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2013

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2013

Completed
2 years until next milestone

First Posted

Study publicly available on registry

December 15, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 15, 2015

Status Verified

December 1, 2015

Enrollment Period

3 years

First QC Date

December 26, 2013

Last Update Submit

December 10, 2015

Conditions

Head and Neck Neoplasms

Keywords

clinical trialRecombinant Human Endostatin Adenovirusrandomized

Outcome Measures

Primary Outcomes (1)

  • Time to progression

    Time to progression is defined as the time from randomization until objective tumor progression as verified for the first time

    Up to 24 weeks

Secondary Outcomes (4)

  • Change in Overall response rate (CR+PR)

    Up to 24 weeks, from date of randomization until the date of first documented progression

  • Chang in disease control rate (CR+PR+SD)

    Up to 24 weeks, From date of randomization until the date of first documented progression

  • Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)

    Up to 32 weeks, from date of randomization until the date of first documented progression or date

  • Overall survival

    Up to 24 month, through study completion

Study Arms (2)

Combination therapy

EXPERIMENTAL

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.

Drug: EndostatinsDrug: Paclitaxel injectionDrug: Cisplatin injection

Chemotherapy

EXPERIMENTAL

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

Drug: Paclitaxel injectionDrug: Cisplatin injection

Interventions

EndostatinsDRUG

Specification: 1mL/division, 1×1012 VP/1.0mL E10A preparation: 1. Thaw frozen E10A stored at -20°C vials at room temperature until E10A is liquid. 2. Swirl gently. Do NOT shake. Method of administration 1. E10A was diluted with 0.9% sodium chloride to appropriate dose according to the longest diameter of the target lesion. 2. After local anesthesia, we penetrated the syringe under normal skin subcutaneously 5 mm into the tumor or vertically into the lymph node under direct visualization and withdrew it to confirm the absence of blood. 3. Applied local compression for 10 minutes and pasted a sterile sticker on the injection site to avoid bleeding.

Also known as: E10A
Combination therapy
Paclitaxel injectionDRUG

Specification: 30mg/5mL, Usage: 160mg/m2 on day 3, according to instruction.

ChemotherapyCombination therapy
Cisplatin injectionDRUG

Specification: 20mg Usage: Cisplatin 25mg/ m2 on day 3, 4, and 5,according to instruction.

ChemotherapyCombination therapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 18 years with histologically or cytologically proven locoregionally advanced or metastatic HNSCC (excluding NPC) not suitable for operation or radiotherapy
  • A life expectancy≧12 weeks.
  • 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,
  • Not received chemotherapy, radiotherapy, or biotherapy within 4 weeks.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-2.
  • Adequate bone marrow,renal, and liver functions.

You may not qualify if:

  • Known allergies to the study drug.
  • The presence of important blood vessels/nerves or ulceration in the target lesion not suitable for injection.
  • Tumor relapses within 6 months after paclitaxel chemotherapy.
  • Severe coagulation disorders or bleeding tendency.
  • Severe uncontrolled medical conditions.
  • Recent history of myocardial infarction acute infection, pregnancy or lactation, or symptomatic brain metastases
  • A history of corticosteroids or immunosuppressives use within four weeks of study entry
  • Received any chemotherapy or radiotherapy within four weeks of study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou DB

Gaungzhou, Guangdong, 510663, China

RECRUITING

Related Publications (2)

  • Ye 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: 24662947RESULT

  • Lin 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: 17426445RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

EndostatinsPaclitaxelCisplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Angiostatic ProteinsAngiogenic ProteinsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsCollagen Type XVIIINon-Fibrillar CollagensCollagenExtracellular Matrix ProteinsScleroproteinsBiological FactorsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Huiqiang Huang, Ph.D

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Huiqiang Huang, Ph.d

CONTACT

(86)2087343350huanghq@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2013

First Posted

December 15, 2015

Study Start

June 1, 2013

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

December 15, 2015

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)