NCT01386242

Recombinant Anti-tumor and Anti-virus Protein for Injection in Treatment of Metastatic Colorectal Cancer

Phase II/III Study of Recombinant Anti-tumor and Anti-Virus Protein for Injection Compared With Placebo in Metastatic Colorectal Cancer After Failure of Second-Line and More Than Second-line Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Explanation for study design The trial including two stages. The first is an exploration stage to decide delivery frequency and dose of study drug. It is single-blinded, subjects will be randomly divided into 4 groups with a 2:2:2:1 ratio. Study drug given twice per week or 3 times per, dose of the drug are from 20μg to 40μg. The sample size is 105, duration is 12 to 18 months. Based on preliminary efficacy and safety, the better dosage regimen will decided for the second stage.The second stage is double-blinded,subject will be randomly divided into treatment group or placebo group with 2:1 ratio and sample size is 600. Primary purpose To compare overall survival between study drug and placebo groups . Secondary purpose 1. Progression free survival were compared in both groups. 2. Disease control rate were compared in both groups. 3. Quality of life scores were compared in both groups. 4. Determine the safety and tolerance of recombinant anti-tumor and anti-virus protein for injection 5. Supplementary pharmacodynamics of recombinant anti-tumor and anti-virus protein for injection Exploratory purpose Evaluate effects of recombinant anti-tumor and anti-virus protein for injection on the anti-tumor immunity, angiogenesis, apoptosis, cell proliferation, immune cells and cytokines levels.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-05-01
• Completion: 2014-05-01
• First posted: 2011-07-01
• Last updated: 2016-01-05

Locations

1 site across 1 country: China