Compare Efficacy and Safety of Raltitrexed-based and 5fu-based Neoadjuvant Chemotherapy for Colorectal Liver Metastasis

Study Overview
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Brief Summary
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This study is a multicenter ,randomization, open control study to evaluate the efficacy and safety of Raltitrexed-based chemotherapy and 5-fluorouracil-based chemotherapy in the peri-operative treatment of patients with Liver Metastasis From colorectal cancer (CRC).

Detailed Description
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The contrast analysis is separately done on Raltitrexed plus oxaliplatin and 5-fluorouracil plus oxaliplatin;Raltitrexed plus irinotecan and 5-fluorouracil plus irinotecan.To investigate the objective response rate,the R0 resection rate, the early tumor shrinkage （ETS）and depth of response(DPR) and the safety profile.

Official Title
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The Second Affiliated Hospital of Zhejiang University

Conditions
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Colorectal Cancer, Liver Metastasis

Intervention / Treatment
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* Drug: Raltitrexed-based chemotherapy
* Drug: Raltitrexed-based chemotherapy
* Drug: 5-fluorouracil-based chemotherapy
* Drug: 5-fluorouracil-based chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed chinese colorectal cancer patients and imaging detection confirmed liver metastasis previously no treatment for liver metastasis or Primary tumor had been removed and last additional chemotherapy over one year Age of≥18 and ≤75 Adequate organ functions, as determined by normal bone marrow function (absolute neutrophil count2 x 109/L, platelets 100 x 109/L, White blood cells 4 x 109/L), liver function (serum bilirubin ≤ 2.5 x ULN, serum transaminases ≤2. 5x ULN) ECOG≤1 Life Expectancy>6months Signed written informed consent Expected adequacy of follow-up Exclusion Criteria: Lesion is too small to assess by imaging Extrahepatic metastases Any anticancer chemotherapy in development within 4 weeks prior to study entry Concurrent uncontrolled illness such as infection Be allergic to medicines in the study Pregnant or nursing patients Fertile women (< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception. Not willing or incapable to comply with all study visits and assessments Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that puts the patient at high risk for treatment-related complications.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Raltitrexed-based chemotherapy<br>Raltitrexed plus Oxaliplatin/Raltitrexed plus Irinotecan | Drug: Raltitrexed-based chemotherapy<br>* Raltitrexed: 2.0mg,iv,15min,d1,Oxaliplatin:85mg/m2 iv,d1, q2w<br>* Other names: RTXOX;Drug: Raltitrexed-based chemotherapy<br>* Raltitrexed: 2.0mg,iv,15min,d1,Irinotecan:180mg/m2 iv,d1, q2w<br>* Other names: RTXIRI;|
| Active Comparator: 5-fluorouracil-based chemotherapy<br>5-fluorouracil plus Oxaliplatin/5-fluorouracil plus Irinotecan | Drug: 5-fluorouracil-based chemotherapy<br>* 5-fluorouracil:400mg/m2,ivp,2h,d1,1200mg/m2/d*2d(2400mg/m2,iv46-48h); Oxaliplatin:85mg/m2 iv,d1,q2w<br>* Other names: mFOLFOX6;Drug: 5-fluorouracil-based chemotherapy<br>* 5-fluorouracil: 400mg/m2,ivp,2h,d1,1200mg/m2/d*2d(2400mg/m2,iv46-48h); Irinotecan:180mg/m2 d1, iv,q2w<br>* Other names: FOLFIRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | 38 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0 resection rate of liver |  | 38 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Cancer, liver metastasis, neoadjuvant chemotherapy