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

NCT ID: NCT01959061

Last Updated: 2017-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Colorectal Cancer Metastatic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Raltitrexed

Intervention Type DRUG

4mg, every 4 weeks,transhepatic arterial infusion

Oxaliplatin

Intervention Type DRUG

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

lipiodol

Intervention Type DRUG

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

Interventions

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Raltitrexed

4mg, every 4 weeks,transhepatic arterial infusion

Intervention Type DRUG

Oxaliplatin

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

Intervention Type DRUG

lipiodol

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Chia-tai Tianqing Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jianhua Wang

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianhua Wang

Role: CONTACT

021-64041990

Facility Contacts

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Jianhua Wang

Role: primary

Other Identifiers

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NJCTTQ-01

Identifier Type: -

Identifier Source: org_study_id

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