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

Phase 4UnknownNCT01959061

Nanjing Chia-tai Tianqing Pharmaceutical320 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

320

Conditions

Colorectal Cancer Metastatic

Interventions

RaltitrexedDRUG

4mg, every 4 weeks,transhepatic arterial infusion

OxaliplatinDRUG

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

lipiodolDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Progression-free survivial

From date of randomization until date of first documented PD, date of death

Time frame: 8 months after last patient randomized

Central Contacts

Jianhua Wang

CONTACT

021-64041990 wang.jianhua@zs-hospital.sh.cn

Data from ClinicalTrials.gov

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