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

Colorectal Cancer Metastatic Clinical Trial

— TACE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01959061
• Other study ID #: NJCTTQ-01
• Status: Recruiting
• Phase: Phase 4
• First received: September 18, 2013
• Last updated: March 9, 2017
• Start date: September 2013
• Est. completion date: December 2017

Study information

• Verified date: March 2017
• Source: Nanjing Chia-tai Tianqing Pharmaceutical
• Contact: Jianhua Wang
• Phone: 021-64041990
• Email: wang.jianhua[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Intervention

Drug:
• Raltitrexed
4mg, every 4 weeks,transhepatic arterial infusion
• Oxaliplatin
100~150mg, every 4 weeks, transhepatic arterial infusion
• lipiodol
5-20ml, every 4 weeks, hepatic artery embolization

Locations

Country	Name	City	State
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Chia-tai Tianqing Pharmaceutical

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survivial	From date of randomization until date of first documented PD, date of death	8 months after last patient randomized