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

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Status and phase: Unknown; Phase 2

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: Novaferon; Drug: Capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT02068131

JH-RC-006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Novaferon+ xeloda

Experimental group

Description:

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.

Treatment:

Drug: Capecitabine

Drug: Novaferon