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

Primary Purpose

Colorectal Cancer Metastatic

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Raltitrexed
Oxaliplatin
lipiodol
Sponsored by
Nanjing Chia-tai Tianqing Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer Metastatic focused on measuring Advanced colorectal cancer of liver metastatic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Pregnant or lactating women
  2. Patients with severe organ dysfunction or failure
  3. With severe cardiovascular disease, or mental
  4. Extraliver metastases

Sites / Locations

  • Zhongshan Hospital Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Raltitrexed and Oxaliplatin

Arm Description

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

Outcomes

Primary Outcome Measures

Progression-free survivial
From date of randomization until date of first documented PD, date of death

Secondary Outcome Measures

Full Information

First Posted
September 18, 2013
Last Updated
March 9, 2017
Sponsor
Nanjing Chia-tai Tianqing Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT01959061
Brief Title
Efficacy and Safety of Raltitrexed-based Transarterial Chemoembolisation(TACE)for Colorectal Cancer Liver Metastases
Acronym
TACE
Official Title
Raltitrexed and Oxaliplatin and Lipiodol Transcatheter Arterial Chemoembolization for Advanced Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing Chia-tai Tianqing Pharmaceutical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the efficacy and safety of Raltitrexed for advanced colorectal cancer
Detailed Description
evaluate the efficacy and safety of Raltitrexed and oxaliplatin and lipiodol transcatheter arthrial chemoembolization for in refractory colorectal carcinoma with liver metastases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Metastatic
Keywords
Advanced colorectal cancer of liver metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Raltitrexed and Oxaliplatin
Arm Type
Experimental
Arm Description
Raltitrexed and Oxaliplatin were mixed with 10-15 ml lipiodol by arterial chemoembolization on day 1 and during each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Raltitrexed
Intervention Description
4mg, every 4 weeks,transhepatic arterial infusion
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
100~150mg, every 4 weeks, transhepatic arterial infusion
Intervention Type
Drug
Intervention Name(s)
lipiodol
Intervention Description
5-20ml, every 4 weeks, hepatic artery embolization
Primary Outcome Measure Information:
Title
Progression-free survivial
Description
From date of randomization until date of first documented PD, date of death
Time Frame
8 months after last patient randomized

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianhua Wang
Phone
021-64041990
Email
wang.jianhua@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianhua Wang
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
2000032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Wang

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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