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
Explanation for study design
The trial including two stages. The first is an exploration stage to decide delivery
frequence of study drug. It is single-blinded, subjects will be randomly divided into 3
groups with a 2:2:1 ratio. Study drug given twice per week or 3 times per week. The sample
size is 75, duration is 2 to 3 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.
To compare overall survival between study drug and placebo groups .
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
5. Supplementary pharmacodynamics of recombinant anti-tumor and anti-virus protein for
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: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Overall survival (OS)
OS is defined as the length of time from random assignment to death or to last contact.
every 8 weeks until death, the average OS is thought to be 4.5~6 months
Xu jianming, M.D.
The Affiliated Hospital of the Chinese Academy of Military Medical Scienc
China: Food and Drug Administration