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

Phase 4

• Conditions: Colorectal Cancer Metastatic
• Interventions: Drug: Raltitrexed; Drug: Oxaliplatin; Drug: lipiodol

• Registration Number: NCT01959061
• Lead Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-18
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-09
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-09
• Last Update Posted: 2017-03-13
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Progression-free survivial	8 months after last patient randomized	From date of randomization until date of first documented PD, date of death

Trial Locations

Locations (1)

Zhongshan Hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China