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Recombinant Anti-tumor and Anti-virus Protein for Injection Plus Xeloda in Treatment of Metastatic Colorectal Cancer

Phase 2
Conditions
Metastatic Colorectal Cancer
Interventions
Drug: Novaferon
Drug: Capecitabine
Registration Number
NCT02068131
Lead Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
30
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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Novaferon+ xelodaNovaferonCapecitabine 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.
Novaferon+ xelodaCapecitabineCapecitabine 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.
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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.

Trial Locations

Locations (1)

307 Hospital of PLA

🇨🇳

Beijing, China

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