This trial is active, not recruiting.

Condition colorectal cancer metastatic
Treatments raltitrexed, oxaliplatin, lipiodol
Phase phase 4
Sponsor Nanjing Chia-tai Tianqing Pharmaceutical
Start date September 2013
End date December 2014
Trial size 320 participants
Trial identifier NCT01959061, NJCTTQ-01


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Ralititrexed, 4mg, every 4 weeks
4mg, every 4 weeks,transhepatic arterial infusion
100~150mg, every 4 weeks, transhepatic arterial infusion
5-20ml, every 4 weeks, hepatic artery embolization

Primary Outcomes

time frame: 4 weeks
time frame: 4 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Raltitrexed and Oxaliplatin and Lipiodol Transcatheter Arterial Chemoembolization 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Nanjing Chia-tai Tianqing Pharmaceutical.