NCT02283489

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.

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
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

4 active sites

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

October 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 5, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

2 years

First QC Date

October 15, 2014

Last Update Submit

November 3, 2014

Conditions

Head and Neck Neoplasms

Keywords

Recombinant Human Endostatin AdenovirusHead and Neck Malignant Tumorclinical trialrandomizedEndostatingene therapy

Outcome Measures

Primary Outcomes (1)

  • Change in Objective response rate (ORR) of target lesion

    Objective response rate (ORR) of target lesion is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR), , determined by tumor assessments from radiological tests including CT and MRI. CR is defined as disappearance of the target lesion. PR is defined as a decrease of at least 30% in the product of two perpendicular diameters of the target lesion.

    During the 2nd and 4th cycle of treatment phase (day 35, day 76) and follow-up (every 3 months after treatment till 2 years).

Secondary Outcomes (4)

  • Change in Disease control rate of target lesion

    During the 2nd and 4th cycle of treatment phase (day 35, day 76) and follow-up (every 3 months after treatment till 2 years).

  • Change in ORR of all lesions

    During the 2nd and 4th cycle of treatment phase (day 35, day 76) and follow-up (every 3 months after treatment till 2 years).

  • Time to progression

    Up to 24 weeks

  • Change in Immune response

    During the screening phase and on days 7, 21, 35, 48, 62, and 76 (day 1 is defined as the first day of chemotherapy with the TP regimen)

Other Outcomes (2)

  • Change in adenovirus in patients' secreta and excreta

    Before the first administration and on days 1 and 3 after the first administration

  • Change in vital signs and physique

    Screening phase (before randomization) and treatment phase (until week 12 after treatment)

Study Arms (3)

Combination therapy A

EXPERIMENTAL

Recombinant human endostatin adenovirus (EDS01), 5.0 × 1011 VP intratumorally on days 0 and 7; paclitaxel, 160 mg/m2 intravenously on day 1; cisplatin, 25 mg/m2 intravenously on days 1 to 3.

Drug: recombinant human endostatin adenovirusDrug: Cisplatin injectionDrug: Paclitaxel injection

Combination therapy B

EXPERIMENTAL

Recombinant human endostatin adenovirus (EDS01), 1.0 × 1012 VP intratumorally on days 0 and 7; paclitaxel, 160 mg/m2 intravenously on day 1; cisplatin, 25 mg/m2 intravenously on days 1 to 3.

Drug: recombinant human endostatin adenovirusDrug: Cisplatin injectionDrug: Paclitaxel injection

Chemotherapy

EXPERIMENTAL

Paclitaxel, 160 mg/m2 intravenously on day 1; cisplatin, 25 mg/m2 intravenously on days 1 to 3.

Drug: Cisplatin injectionDrug: Paclitaxel injection

Interventions

recombinant human endostatin adenovirusDRUG

Specification: 1mL/division, 1.0×1012 virus particle (VP). ESD01 preparation: Thaw at room temperature, dilute with normal saline to required volume (no more than 2 mL). Method of administration: Intratumor injection, once a week for 2 weeks, every 3 weeks for one cycle. Select only one target lesion even when lesions are present. The target lesion is the largest and easiest to inject. This will be fixed during the study.

Also known as: EDS01 (20140303)
Combination therapy ACombination therapy B
Cisplatin injectionDRUG

Specification: 2ml: 10mg. Usage: 25mg/m2, days 1 to 3, according to instruction.

ChemotherapyCombination therapy ACombination therapy B
Paclitaxel injectionDRUG

Specification: 5ml: 30mg. Usage: 160mg/m2 intravenously on day 1, according to instruction.

ChemotherapyCombination therapy ACombination therapy B

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

RECRUITING

Chongqing Cancer Hospital

Chongqing, 400030, China

RECRUITING

Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University School of Medicine

Shanghai, 200011, China

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

CisplatinPaclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Renmiao Zhang, MD, PhD

    Chengdu Shi Endor Biological Engineering Technology Co., Ltd

    STUDY DIRECTOR

Central Study Contacts

Renmiao Zhang

CONTACT

zrm_eds001@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Project leader

Study Record Dates

First Submitted

October 15, 2014

First Posted

November 5, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations

CN(4)