Metastatic Colorectal Cancer Clinical Trial
Official title:
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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