Recombinant Anti-tumor and Anti-virus Protein for Injection Plus Xeloda in Treatment of Metastatic Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT02068131|
Recruitment Status : Unknown
Verified August 2015 by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences.
Recruitment status was: Recruiting
First Posted : February 21, 2014
Last Update Posted : January 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Drug: Novaferon Drug: Capecitabine||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Recombinant Anti-tumor and Anti-Virus Protein for Injection Plus Capatabine in Treating Patients With Metastatic Colorectal Cancer After Failure of Standard Treatment|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||December 2016|
Experimental: Novaferon+ xeloda
Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).
Recombinant anti-tumor and anti-virus protein for injection(Novaferon), three times per week.
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).
Other Name: Brand name:Xeloda
- Overall response rate(ORR) [ Time Frame: every 6 weeks until disease progression,assessed up to 6 months ]ORR is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments.
- Disease control rate(DCR) [ Time Frame: every 6 weeks until disease progression,assessed up to 6 months ]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.
- Progression-free survival (PFS) [ Time Frame: every 6 weeks until disease progression,assessed up to 6 months ]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.
- Overall survival (OS) [ Time Frame: every 8 weeks until death,assessed up to 2 years ]OS is defined as the length of time from random assignment to death or to last contact.
- Adverse Events(AEs) [ Time Frame: from informed consent form signed to 30 days after termination of administration,assessed up to 6 months ]AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068131
|Contact: Xu Jianming, M.D.||+email@example.com|
|307 Hospital of PLA||Recruiting|
|Beijing, China, 100071|
|Contact: Xu Jianming +861051128358 firstname.lastname@example.org|
|Principal Investigator: Xu jianming, M.D.|
|Principal Investigator:||Xu Jianming, M.D.||307 Hospital of PLA|