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Phase II/III Study of Recombinant Anti-tumor and Anti-Virus Protein for Injection Compared With Placebo in Metastatic Colorectal Cancer After Failure of Second-Line and More Than Second-line Treatment

Phase 2/Phase 3
18 Years
Open (Enrolling)
Metastatic Colorectal Cancer

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Trial Information

Phase II/III Study of Recombinant Anti-tumor and Anti-Virus Protein for Injection Compared With Placebo in Metastatic Colorectal Cancer After Failure of Second-Line and More Than Second-line Treatment

Explanation for study design

The trial including two stages. The first is an exploration stage to decide delivery
frequence of study drug. It is single-blinded, subjects will be randomly divided into 3
groups with a 2:2:1 ratio. Study drug given twice per week or 3 times per week. The sample
size is 75, duration is 2 to 3 months. Based on preliminary efficacy and safety, the better
dosage regimen will decided for the second stage.The second stage is double-blinded,subject
will be randomly divided into treatment group or placebo group with 2:1 ratio and sample
size is 600.

Primary purpose

To compare overall survival between study drug and placebo groups .

Secondary purpose

1. Progression free survival were compared in both groups.

2. Disease control rate were compared in both groups.

3. Quality of life scores were compared in both groups.

4. Determine the safety and tolerance of recombinant anti-tumor and anti-virus protein for

5. Supplementary pharmacodynamics of recombinant anti-tumor and anti-virus protein for

Exploratory purpose Evaluate effects of recombinant anti-tumor and anti-virus protein for
injection on the anti-tumor immunity, angiogenesis, apoptosis, cell proliferation, immune
cells and cytokines levels.

Inclusion Criteria:

- Aged above 18 years.

- ECOG performance status 0, 1 or 2.

- Pathologically confirmed metastatic colorectal cancer.

- Failure of Second-Line or Above Treatment, and irinotecan- and
oxaliplatin--containing regimens (If recurrence and metastasis occurred within 6
months after discontinuation of adjuvant chemotherapy, the adjuvant chemotherapy is
considered to be first-line treatment). more than 4 weeks before enrollment after
discontinuation of chemotherapy.

- 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

- 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.

- The organ function is normal (laboratory test results came within 1 week before
administration in the absence of ongoing supportive care): ANC ≥ 1.5 x 109/L,
Platelets ≥ 80 x 109/L, Hgb ≥ 8.5 g/dL, serum total bilirubin ≤ 1.5 x upper limit of
normal (ULN), and serum AST and ALT ≤ 2.5 x ULN(≤ 5 x ULN if liver metastases), serum
creatinine ≤1.5 x ULN.

- Have been fully aware of the study and voluntarily signed the informed consent.

- Life expectancy of at least 3 months.

Exclusion Criteria:

- 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.

- Patient with any other Malignant tumors within five years (except for a complete cure
of carcinoma in situ of the cervix or basal cell cancer or squamous cell skin

- Patient with Clinically uncontrolled active infection such as acute pneumonia, active
hepatitis B, etc.

- Patient associated with Significant Systemic illness including, but not limited to,
the following: cerebrovascular disease, uncontrolled diabetes, uncontrolled
hypertension, acute myocardial infarction, unstable angina, Congestive heart failure
,serious dysrhythmias, metabolic diseases, thrombosis or thromboembolic events
occurred(including transient ischemic attack) in the last 6 months.

- Patient with serious autoimmune diseases in the past or at present, such as systemic
lupus erythematosus, rheumatoid arthritis, thyroiditis, etc.

- Patient with ascites, pleural and pericardial effusion that cannot be controlled by
drainage or symptomatic treatment.

- Investigator think Patient is not appropriate to participate in this trial for any
clinical or laboratory abnormalities, or patient with any grade ≥ 2 toxicity
according to NCI CTC AE 3.0 standard .

- Patient who also are accepting other systemic anti-tumor therapy (local radiotherapy
for the control of bone metastases is not the limit)), in this study received 4 weeks
before the start of drug treatment of other tests.

- Patient who had serious psychological or psychiatric disorder or Drug addiction or
alcohol dependence.

- Patient who are estimated to be lack of compliance in this study.

- Patient with acute or subacute intestinal obstruction.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall survival (OS)

Outcome Description:

OS is defined as the length of time from random assignment to death or to last contact.

Outcome Time Frame:

every 8 weeks until death, the average OS is thought to be 4.5~6 months

Safety Issue:


Principal Investigator

Xu jianming, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Affiliated Hospital of the Chinese Academy of Military Medical Scienc


China: Food and Drug Administration

Study ID:




Start Date:

May 2011

Completion Date:

May 2013

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal Cancer
  • Novaferon
  • Colorectal Neoplasms