Overview

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

Status:
Unknown status
Trial end date:
2016-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Treatments:
Capecitabine
Criteria
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.