The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor and anti-virus protein for injection plus capecitabine in treating patients with metastatic colorectal cancer who have progressed after standard therapy.
This is a Phase Ⅱ exploratory clinical study. The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor and anti-virus protein for injection plus capecitabine in treating patients with metastatic colorectal cancer who have progressed after standard therapy. All patients will receive recombinant anti-tumor and anti-virus protein for injection and capecitabine.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Recombinant anti-tumor and anti-virus protein for injection, 10μg, im, 3 times per week for first 2 weeks, followed by 20μg,im, 3 times per week after 2 weeks.
The dose of capecitabine is 1250 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2500 mg/m2).
307 Hospital of PLA
Beijing, China
RECRUITINGOverall response rate(ORR)
ORR is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments.
Time frame: every 6 weeks until disease progression,assessed up to 6 months
Disease control rate(DCR)
DCR is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments.
Time frame: every 6 weeks until disease progression,assessed up to 6 months
Progression-free survival (PFS)
PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.
Time frame: every 6 weeks until disease progression,assessed up to 6 months
Overall survival (OS)
OS is defined as the length of time from random assignment to death or to last contact.
Time frame: every 8 weeks until death,assessed up to 2 years
Adverse Events(AEs)
AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
Time frame: from informed consent form signed to 30 days after termination of administration,assessed up to 6 months
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