Metastatic Colorectal Cancer
Conditions
Keywords
Metastatic Colorectal Cancer, Novaferon, Recombinant anti-tumor and anti-virus protein for injection, xeloda
Brief summary
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.
Detailed description
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.
Interventions
DRUGNovaferon
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.
DRUGCapecitabine
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).
Sponsors
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged above 18 years. * Pathologically confirmed metastatic adenocarcinoma of the colon or rectum. All other histological types are excluded. * Failure of Second-Line and more than second-line treatment, and fluoropyrimidine- and irinotecan- and oxaliplatin-containing regimens.(Subjects who progress during or within 3 months following the last administration of approved standard therapies and terminate standard treatment due to unacceptable toxicity warranting.).If recurrence and metastasis occurred within 6 months after discontinuation of adjuvant chemotherapy, the adjuvant chemotherapy is considered to be first-line treatment.Subject received last-line treatment not including capecitabine. * At least one measurable lesion according to the RECIST criteria that has not been previously local treated. Minimum indicator lesion size as follows: greater than or equal to 10 mm measured by spiral CT or NMR.Malignant lymph nodes short diameter as follows: greater than or equal to 15 mm measured by spiral CT. * ECOG performance status 0, 1 or 2. * Minimum of 4 weeks since any local radiotherapy or surgery for the control of symptoms or severe complications(local radiotherapy for the control of bone metastases is not the limit)，and adequately recovered from toxicities of any prior therapy). * Life expectancy of at least 3 months.
Exclusion criteria
* Prior treatment with novaferon. * Pregnancy or breast-feeding women or women who may be pregnant were positive drug test before administration. * Patient of child-bearing potential(male or less than 1 year postmenopausal women) were reluctant to take contraceptive measures. * Patient who were allergic to Interferon-α or who had interferon-α antibody. * Patients with uncontrolled central nervous system (CNS) metastases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate(ORR) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate(DCR) | 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) | 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) | 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) | 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. |
Countries
China
Contacts
Primary ContactXu Jianming, M.D.
Outcome results
None listed