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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01959061
Recruitment Status : Unknown
Verified March 2017 by Nanjing Chia-tai Tianqing Pharmaceutical.
Recruitment status was:  Recruiting
First Posted : October 9, 2013
Last Update Posted : March 13, 2017
Information provided by (Responsible Party):
Nanjing Chia-tai Tianqing Pharmaceutical

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
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 : September 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Progression-free survivial [ Time Frame: 8 months after last patient randomized ]
    From date of randomization until date of first documented PD, date of death

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01959061

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Contact: Jianhua Wang 021-64041990

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China, Shanghai
Zhongshan Hospital Fudan University Recruiting
Shanghai, Shanghai, China, 2000032
Contact: Jianhua Wang         
Sponsors and Collaborators
Nanjing Chia-tai Tianqing Pharmaceutical
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Principal Investigator: Jianhua Wang Fudan University

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Responsible Party: Nanjing Chia-tai Tianqing Pharmaceutical Identifier: NCT01959061     History of Changes
Other Study ID Numbers: NJCTTQ-01
First Posted: October 9, 2013    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Nanjing Chia-tai Tianqing Pharmaceutical:
Advanced colorectal cancer of liver metastatic

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Ethiodized Oil
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Enzyme Inhibitors