Oxaliplatin and Raltitrexed Treatment of Colorectal Cancer With Liver Metastases

A Randomized Controlled Trial of TACE Hepatic Artery Infusion of Oxaliplatin and Raltitrexed Treatment of Colorectal Cancer With Liver Metastases

The purpose of this study was a randomized controlled trial to compare the effect of oxaliplatin and raltitrexed treatment of colorectal cancer with liver metastases by TACE hepatic artery infusion

Study Overview

• Status: Unknown
• Conditions: Colon Cancer Liver Metastasis
• Intervention / Treatment: Drug: oxaliplatin and raltitrexed

Detailed Description

Colorectal cancer is one of the most common malignancies, with 1 million new cases and half a million deaths each year worldwide. The development of metastases is the main cause of death. Liver metastases are diagnosed in 10-25% of patients at the time of resection of their primary colorectal tumor and, eventually, up to 70% of patients with colorectal cancer develop liver metastases.Oxaliplatin and raltitrexed were used for the treatment of colorectal cancer with liver metastases. We aimed to perform a randomized controlled trial to compare the effect of oxaliplatin and raltitrexed treatment of colorectal cancer with liver metastases by TACE hepatic artery infusion.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. With written informed consent
2. Age ranged from 18 to 80 years, both men and women
3. Confirmed by pathology or clinical diagnosis of unresectable colorectal cancer with liver metastases patients(including the primary tumor and liver in patients with brain metastases except outside of metastasis in patients with unresectable)
4. Progress systemic chemotherapy or who can not tolerate chemotherapy, or who refuse chemotherapy
5. Never received TACE treatment
6. (M) RECIST 1.0 criteria measurable liver lesions at several ≥2, each lesion diameter ≥3 cm long and ≤20cm,
7. ECOG PS score of ≤2
8. expected survival time ≥12 weeks

9. The test results before 7 days entered the group must meet the following requirements:

   • Hemoglobin ≥ 90 g / L
   • Absolute neutrophil count (ANC)> 1,500 / mm3
   • Platelet count ≥ 80x109 / L
   • Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <5 times the upper limit of normal (UNL)
   • Total bilirubin <3UNL
   • Serum creatinine <1.5 UNL
   • PT or INR, PPT <1.5 UNL (for patients undergoing warfarin or heparin anticoagulant therapy, if there is no evidence that there is an abnormality of the above parameters, you can enter the group, but must be closely monitored to detect at least once a week until the INR stable)

Exclusion criteria

1. Specific circumstances of patients not suitable for TACE therapy / chemotherapy
2. Hepatic decompensation, or the presence of hepatic encephalopathy
3. Before entering the study with gastrointestinal bleeding within 30 days
4. Presence of brain metastasis
5. Pregnant or lactating women
6. Active bleeding or sepsis

7. History of heart disease:

   • NYHA two or more of congestive heart failure, symptomatic coronary artery disease
   • Need to use β-blockers or digoxin medication other than arrhythmias
8. Despite treatment, still systolic blood pressure> 150 mmHg or diastolic blood pressure> 90 mmHg hypertension
9. Not cure severe trauma, acute or incurable ulcer, or three months fracture
10. The researchers believe their poor compliance
11. Exist once or primary lesion or histologically different tumors and colorectal cancer, except: head and neck carcinoma in situ, cured basal cell carcinoma, superficial bladder cancer (Ta, Tis, T1), and the group 3 years ago, it has been cured of cancer
12. HIV infection or the presence of AIDS-related illness, or severe acute and chronic diseases
13. Drug abuse, or suffering that could interfere with study compliance and other psychological or psychiatric disorders
14. Need drug therapy epilepsy (such as steroids or antiepileptic drugs
15. Chemotherapy contraindications exist
16. Any instability or likely to endanger the patient in this study the safety and compliance of the case

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxaliplatin by TACE; Oxaliplatin for the therapy of Colorectal Cancer With Liver Metastases by TACE.No interventions was raltitrexed for the therapy of Colorectal Cancer With Liver Metastases by TACE.	Drug: oxaliplatin and raltitrexed; TACE methods: use of epirubicin 20-40mg emulsifier lipiodol embolization target vessel, with gelatin sponge particles or PVA particles or microspheres embolization supplement. Hepatic arterial chemotherapy: Bi embolization catheter in the hepatic artery or left hepatic artery branch within the right, chemotherapy, for the experimental group (A group): OXA 130mg / m2 artery 0-4 hours pumped Raltitrexed 3mg/m2 4-5 hours pumped into the arteries; the control group (group B)
No Intervention: Raltitrexed by TACE; Raltitrexed for the therapy of Colorectal Cancer With Liver Metastases by TACE.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival (PFS)	three years

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival (OS)	three years

Collaborators and Investigators

• Sponsor: Zhu Xu

Publications and helpful links

General Publications

• Feng AW, Guo JH, Gao S, Kou FX, Liu SX, Liu P, Chen H, Wang XD, Xu HF, Cao G, Zhu X. A randomized phase II trial of hepatic arterial infusion of oxaliplatin plus raltitrexed versus oxaliplatin plus 5-fluorouracil for unresectable colorectal cancer liver metastases. Front Oncol. 2022 Sep 21;12:913017. doi: 10.3389/fonc.2022.913017. eCollection 2022.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: September 22, 2015
• First Submitted That Met QC Criteria: September 22, 2015
• First Posted (Estimate): September 23, 2015

Study Record Updates

• Last Update Posted (Estimate): September 23, 2015
• Last Update Submitted That Met QC Criteria: September 22, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: TACE; hepatic artery infusion; oxaliplatin; raltitrexed
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Neoplastic Processes; Neoplasm Metastasis; Liver Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Folic Acid Antagonists; Oxaliplatin; Raltitrexed
• Other Study ID Numbers: 2014YJZ16