Overview

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

Status:
Terminated
Trial end date:
2019-09-11
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Zhejiang University
Treatments:
Fluorouracil
Irinotecan
Oxaliplatin
Raltitrexed
Criteria
Inclusion Criteria:

1. Histologically confirmed chinese colorectal cancer patients and imaging detection
confirmed liver metastasis

2. previously no treatment for liver metastasis or Primary tumor had been removed and
last additional chemotherapy over one year

3. Age of≥18 and ≤75

4. 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)

5. ECOG≤1

6. Life Expectancy>6months

7. Signed written informed consent

8. Expected adequacy of follow-up

Exclusion Criteria:

1. Lesion is too small to assess by imaging

2. Extrahepatic metastases

3. Any anticancer chemotherapy in development within 4 weeks prior to study entry

4. Concurrent uncontrolled illness such as infection

5. Be allergic to medicines in the study

6. Pregnant or nursing patients

7. Fertile women (< 2 years after last menstruation) and men of childbearing potential
not willing to use effective means of contraception.

8. Not willing or incapable to comply with all study visits and assessments

9. 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.