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

March 9, 2017 updated by: Nanjing Chia-tai Tianqing Pharmaceutical

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 2000032
        • Recruiting
        • Zhongshan Hospital Fudan University
        • Contact:
          • Jianhua Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survivial
Time Frame: 8 months after last patient randomized
From date of randomization until date of first documented PD, date of death
8 months after last patient randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Chia-tai Tianqing Pharmaceutical

Investigators

  • Principal Investigator: Jianhua Wang, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 18, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 9, 2013

Study Record Updates

Last Update Posted (Actual)

March 13, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NJCTTQ-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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