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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
360
Raltitrexed: 2.0mg,iv,15min,d1,Oxaliplatin:85mg/m2 iv,d1, q2w
Raltitrexed: 2.0mg,iv,15min,d1,Irinotecan:180mg/m2 iv,d1, q2w
5-fluorouracil:400mg/m2,ivp,2h,d1,1200mg/m2/d\*2d(2400mg/m2,iv46-48h); Oxaliplatin:85mg/m2 iv,d1,q2w
The Affiliated Tumor Hospital of Zhongshan University
Guangzhou, Guangdong, China
Wuhan Union Hospital
Wuhan, Hubei, China
Zhongnan Hospital Affiliated to Wuhan University
Wuhan, Hubei, China
Objective response rate
Time frame: 38 months
R0 resection rate of liver
Time frame: 38 months
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5-fluorouracil: 400mg/m2,ivp,2h,d1,1200mg/m2/d\*2d(2400mg/m2,iv46-48h); Irinotecan:180mg/m2 d1, iv,q2w
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of College of Medicine Zhejiang University
Hangzhou, Zhejiang, China
Second Affiliated Hospitalof Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Jinhua People's Hospital
Jinhua, Zhejiang, China
The second hospital of Ningbo City
Ningbo, Zhejiang, China