Recombinant Anti-tumor and Anti-virus Protein for Injection in Treatment of Metastatic Colorectal Cancer
NCT01386242 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108
Last updated 2016-01-05
Summary
The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor and anti-virus protein for injection in treating patients with metastatic colorectal cancer after failure of second-line and more than second-line treatment.
Conditions
Interventions
- DRUG
-
Recombinant anti-tumor and anti-virus protein for injection
Recombinant anti-tumor and anti-virus protein for injection,10μg,im,twice per week for first 2 weeks, followed by 20μg, im, twice per week after 2 weeks
- DRUG
-
Recombinant anti-tumor and anti-virus protein for injection
Recombinant anti-tumor and anti-virus protein for injection, 10μg/1mL,im,three times per week for first 2 weeks, followed by 20μg,im, three times per week after 2 weeks.
- OTHER
-
Saline Injection
Saline Injection, 1mL, im,three times per week
- DRUG
-
Recombinant anti-tumor and anti-virus protein for injection
Recombinant anti-tumor and anti-virus protein for injection, 10μg, im, three times per week for first week, followed by 20μg for two weeks, and followed by 30μg for a week, and followed a maintenance dose of 40μg, the frequency of administration is three times per week.
Sponsors & Collaborators
-
Beijing Genova Biotech Company, Ltd.
collaborator INDUSTRY -
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
lead OTHER
Principal Investigators
-
Xu jianming, M.D. · The Affiliated Hospital of the Chinese Academy of Military Medical Scienc
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-05-31
- Primary Completion
- 2013-05-31
- Completion
- 2014-05-31
Countries
- China
Study Locations
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