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Safety of TACE With Oxaliplatin, Irinotecan and Raltitrexed for Refractory Colorectal Cancer Liver Metastasis | Clinical Trials | Clareo Health

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Safety of TACE With Oxaliplatin, Irinotecan and Raltitrexed for Refractory Colorectal Cancer Liver Metastasis

An Observational Study of TACE Hepatic Arterial Infusion of Oxaliplatin, Irinotecan and Raltitrexed Treatment for Refractory Liver Metastasis From Colorectal Cancer

NCT02631564•Fudan University

View on ClinicalTrials.gov

Summary

The purpose of this study is to observe whether hepatic infusion by oxaliplatin, irinotecan and raltitrexed with or without embolization by lipiodol or microspheres are effective in the treatment of refratory liver metastasis from colorectal cancer.

Detailed Description

Colorectal cancer is one of most popular cancer worldwide. Patients with liver metastasis have poor prognosis except for curative resection. Chemotherapy combined biologic agents have improved mCRC median progress free survival and median overall surivival, but it is difficult to deal with liver lesions after FOLFOX and FOLFIRI treatments failed. We aim to observe the safety and efficacy of hepatic infusion and embolization of oxaliplatin, irinotecan and raltitrexed treatment for refratory liver metastasis from colorectal cancer.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have a histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is metastatic to the liver and for which standard curative measures do not exist
•Patients must have received prior irinotecan-based treatment for their disease and had documented progression by RECIST criteria; patients must also have received prior fluoropyrimidine and oxaliplatin-based therapy
•Liver disease must not be amenable to potentially curative surgical resection
•Patients must have liver-only or liver-predominant disease to be eligible for this study; hepatic disease must be dominant, but patients are allowed to have extrahepatic disease provided it is not judged likely to be life threatening within 3 months
•Patients must have a patent portal vein as documented by CT, MRI, or ultrasound
•Prior radiation therapy is allowed but must have been completed \>= 4 weeks prior to study entry; patients with history of prior radiation to the liver including radio-labeled microspheres cannot take part in this study
•Eastern Cooperative Oncology Group performance status 0-1
•Previous surgery or RFA to the liver is allowed; patients with history of chemoembolization or radio-labeled microspheres are excluded
•Life expectancy of \>= 12 weeks
•Leukocytes \>= 3,000/uL
+8 more criteria

Exclusion Criteria

•Hepatic decompensation, or the presence of hepatic encephalopathy Before entering the study with gastrointestinal bleeding within 30 days
•Pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including death from the therapeutic agents
•Patients with known brain metastases are excluded from this study because of their poor prognosis and frequent development of progressive neurological dysfunction that would confound the evaluation of neurologic and other adverse events
•As patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, known HIV-positive patients and those with known hepatitis B or C are excluded from the study Uncontrolled intercurrent illness including, but not limited to, ongoing or active bacterial infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
•Patients with evidence of other cancer within 5 years, excluding adequately treated basal cell carcinoma of the skin
•Patient with significant cardiac, renal or hematologic or pulmonary dysfunction
•Patients with previous chemoembolization to liver metastases Patients may not receive any other anticancer therapy while on study, including immunotherapy; patients may not receive any other clinical investigational drug

Locations (1)

Fudan University Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

June 1, 2015

Primary Completion Date

June 1, 2017

Completion Date

December 1, 2018

Last Updated

December 16, 2015

Enrollment

200

ESTIMATED participants

Conditions

Colon Cancer Liver Metastasis

Contacts

Bo Zhou, M.D, Ph.D

CONTACT

8621-18616880602 bonheurzhou@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 16, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety of TACE With Oxaliplatin, Irinotecan and Raltitrexed for Refractory Colorectal Cancer Liver Metastasis

Inclusion Criteria

Exclusion Criteria

Biopsy After Radioembolization to Identify Changes in Tumor Cells From the Radiation

Argipressin's Influence on Blood Loss During Hepatic Resection

Diffusion-Weighted MRI for Liver Metastasis

Irinotecan-Eluting Bead (DEBIRI) for Patients With Liver Metastases From Colorectal Cancer