Overview

Condition colorectal cancer metastatic
Treatments raltitrexed, oxaliplatin, lipiodol
Phase phase 4
Sponsor Nanjing Chia-tai Tianqing Pharmaceutical
Start date September 2013
End date December 2017
Trial size 320 participants
Trial identifier NCT01959061, NJCTTQ-01

Summary

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

Recruiting in the following locations…

United States No locations recruiting
Other countries China

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
Raltitrexed and Oxaliplatin were mixed with 10-15 ml lipiodol by arterial chemoembolization on day 1 and during each 28-day cycle.
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

Primary Outcomes

Measure
Progression-free survivial
time frame: 8 months after last patient randomized

Eligibility Criteria

All participants from 18 years up to 75 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
Principal investigator Jianhua Wang
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 March 2017.
Information provided to ClinicalTrials.gov by Nanjing Chia-tai Tianqing Pharmaceutical.