Infections

All Conditions

Neoplasms

Digestive System Diseases

Virus Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Antimetabolites

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.

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.

Novaferon

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).

Xu Jianming, M.D.

Xu Jianming

Xu jianming, M.D.

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.

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.

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

Phase II Study of Recombinant Anti-tumor and Anti-Virus Protein for Injection Plus Capatabine in Treating Patients With Metastatic Colorectal Cancer After Failure of Standard Treatment

ORR is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments.

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.

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.

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

AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Anti-Infective Agents

Interferons

Antiviral Agents

Recombinant anti-tumor and anti-virus protein for injection, twice per week

Recombinant anti-tumor and anti-virus protein for injection, three times per week

High dose of recombinant anti-tumor and anti-virus protein for injection, three times per week

Recombinant anti-tumor and anti-virus protein for injection,10μg,im,twice per week for first 2 weeks, followed by 20μg, im, twice per week after 2 weeks

Recombinant anti-tumor and anti-virus protein for injection

Recombinant anti-tumor and anti-virus protein for injection, 10μg/1mL,im,three times per week for first 2 weeks, followed by 20μg,im, three times per week after 2 weeks.

Saline Injection, 1mL, im,three times per week

Saline Injection

Recombinant anti-tumor and anti-virus protein for injection, 10μg, im, three times per week for first week, followed by 20μg for two weeks, and followed by 30μg for a week, and followed a maintenance dose of 40μg, the frequency of administration is three times per week.

The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor and anti-virus protein for injection in treating patients with 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 frequency and dose of study drug. It is single-blinded, subjects will be randomly divided into 4 groups with a 2:2:2:1 ratio. Study drug given twice per week or 3 times per, dose of the drug are from 20μg to 40μg. The sample size is 105, duration is 12 to 18 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 injection
5. Supplementary pharmacodynamics of recombinant anti-tumor and anti-virus protein for injection

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.

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

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

Quality of life is assessed using EORTC-C30 (the Quality of Life Questionnaire of the European Organisation for Research and Treatment of Cancer.)

AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v3.0.

As the drug concentration is very low, and no commercialized kits for original drug test, So original drug will not detect. Mopterin and MxA protein (alternate index) levels in serum will be used as alternative targets for pharmacodynamic studies

The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Recombinant Anti-tumor and Anti-virus Protein for Injection Plus Xeloda in Treatment of Metastatic Colorectal Cancer	NCT02068131	Metastatic Colo...	Novaferon Capecitabine	18 Years -	The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Recombinant Anti-tumor and Anti-virus Protein for Injection in Treatment of Metastatic Colorectal Cancer	NCT01386242	Metastatic Colo...	Recombinant ant... Recombinant ant... Saline Injectio... Recombinant ant...	18 Years -	The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Recombinant Anti-tumor and Anti-virus Protein for Injection in Treatment of Metastatic Colorectal Cancer	NCT01386242	Metastatic Colo...	Recombinant ant... Recombinant ant... Saline Injectio... Recombinant ant...	18 Years -	The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Spots Global Cancer Trial Database for novaferon

Every month we try and update this database with for novaferon cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for novaferon

Every month we try and update this database with for novaferon cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for novaferon cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.