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

CTTQ

Status and phase: Unknown; Phase 4

Conditions: Colorectal Cancer Metastatic

Treatments: Drug: Oxaliplatin; Drug: Raltitrexed; Drug: lipiodol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01959061

NJCTTQ-01

Details and patient eligibility

About

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

Full description

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

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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320 participants in 1 patient group

Raltitrexed and Oxaliplatin

Experimental group

Description:

Raltitrexed and Oxaliplatin were mixed with 10-15 ml lipiodol by arterial chemoembolization on day 1 and during each 28-day cycle.

Treatment:

Drug: Raltitrexed

Drug: Oxaliplatin

Drug: lipiodol