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 advanced neuroendocrine tumors who have failed standard treatment or are unable to receive standard treatment.
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 in treating patients with advanced neuroendocrine tumors who have failed standard treatment or are unable to receive standard treatment. Recombinant anti-tumor and anti-virus protein for injection, 10μg,im,3 times for the first week, followed by 20μg for two weeks, and followed a maintenance dose of 30μg, the frequency of administration is three times per week. Treatment continued until the patient died or had unacceptable toxicity or had disease progression or required to discontinue the treatment. At the time of disease progression, if investigators believe patients can continue to benefit from the investigational product, patients may be provided with recombinant anti-tumor and anti-virus protein for injection,but only survival follow-up datas will be recorded.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Recombinant anti-tumor and anti-virus protein for injection, 10μg, im, 3 times for first week,followed by 20μg for two weeks, and followed a maintenance dose of 30μg, the frequency of administration is three times per week.
307 Hospital of PLA
Beijing, Beijing Municipality, China
RECRUITINGProgression-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: 1 year
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: 1 year
Overall 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: 1 year
Overall survival (OS)
OS is defined as the length of time from random assignment to death or to last contact
Time frame: 3 years
Adverse Events(AEs)
AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
Time frame: 1 year
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