Efficacy and Safety of Raltitrexed-based Transarterial Chemoembolisation(TACE)for Colorectal Cancer Liver Metastases

Sponsor

Nanjing Chia-tai Tianqing Pharmaceutical (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01959061

Collaborator

(none)

320

Enrollment

Location

Arm

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the efficacy and safety of Raltitrexed for advanced colorectal cancer

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Metastatic	Drug: Raltitrexed Drug: Oxaliplatin Drug: lipiodol	Phase 4

Detailed Description

evaluate the efficacy and safety of Raltitrexed and oxaliplatin and lipiodol transcatheter arthrial chemoembolization for in refractory colorectal carcinoma with liver metastases.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

320 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Raltitrexed and Oxaliplatin and Lipiodol Transcatheter Arterial Chemoembolization for Advanced Colorectal Cancer

Actual Study Start Date :

Sep 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Raltitrexed and Oxaliplatin Raltitrexed and Oxaliplatin were mixed with 10-15 ml lipiodol by arterial chemoembolization on day 1 and during each 28-day cycle.	Drug: Raltitrexed 4mg, every 4 weeks,transhepatic arterial infusion Drug: Oxaliplatin 100~150mg, every 4 weeks, transhepatic arterial infusion Drug: lipiodol 5-20ml, every 4 weeks, hepatic artery embolization

Arm

Intervention/Treatment

Experimental: Raltitrexed and Oxaliplatin

Raltitrexed and Oxaliplatin were mixed with 10-15 ml lipiodol by arterial chemoembolization on day 1 and during each 28-day cycle.

Drug: Raltitrexed

4mg, every 4 weeks,transhepatic arterial infusion

Drug: Oxaliplatin

100~150mg, every 4 weeks, transhepatic arterial infusion

Drug: lipiodol

5-20ml, every 4 weeks, hepatic artery embolization

Outcome Measures

Primary Outcome Measures

Progression-free survivial [8 months after last patient randomized]
From date of randomization until date of first documented PD, date of death

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologically confirmed colorectal adenocarcinoma
Disease limited to the liver Unresectable disease by surgery or other local therapies
Age >18 years
ECOG performance status 0-2,Child pugh A or B
Expected survival ≥ 3 months
Adequate hematological, hepatic, and renal function

Exclusion Criteria:

Pregnant or lactating women
Patients with severe organ dysfunction or failure
With severe cardiovascular disease, or mental
Extraliver metastases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Hospital Fudan University	Shanghai	Shanghai	China	2000032

Sponsors and Collaborators

Nanjing Chia-tai Tianqing Pharmaceutical

Investigators

Principal Investigator: Jianhua Wang, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nanjing Chia-tai Tianqing Pharmaceutical

ClinicalTrials.gov Identifier:

NCT01959061

Other Study ID Numbers:

NJCTTQ-01

First Posted:

Oct 9, 2013

Last Update Posted:

Mar 13, 2017

Last Verified:

Mar 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Nanjing Chia-tai Tianqing Pharmaceutical

Advanced colorectal cancer of liver metastatic

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 13, 2017