Feasibility Study of SOL (S-1,Oral Leucovorin,and Oxaliplatin) for Colorectal Cancer in China

• Endpoints:
• Primary endpoints: adverse drug reaction
• Secondary endpoints:

• Overall Response Rate：ORR
• Progress Free Survival: PFS
• Time to Treatment Failure：TTF

Inclusion criteria

• Advanced unresectable or recurrent colorectal cancer patients which meet the following criteria:

• Willing to sign ICF
• Could orally take investigational product
• Pathology diagnosis is adenocarcinoma
• Above 20 years
• No previous treatment(including: radiotherapy,chemotherapy and immunotherapy)
• For recurrent cases, if the patient had received adjuvant chemotherapy that didn't include S-1 and L-OHP in 180 days ago, he/she could be enrolled in
• With target lesions with diameter which is longer than 1cm in spiral CT or MRI examination within 30 days
• Lab test within 15 days meet following criteria

• Hemoglobin higher than 9.0g/dL
• Leukocyte higher than 12,000/mm3
• Neutrophil higher than 2,000/mm3
• PLT higher than 10.0 104/mm3
• Bilirubin lower than 1.5 times of upper limit of normal range
• AST,ALT,ALP lower than 2.5 times of upper limit of normal range
• Creatinine lower than upper limit of normal range

When patient has liver metastasis or bone metastasis, the value of AST,ALT,ALP could be within 5 times of upper limit of normal range

• ECOG 0 or 1
• Expected survival time more than 90 days

Exclusion criteria

• The patient who meet the following criteria should be excluded from this trial
• Patients who have severe drug allergic history(including: platinum related drugs,5-FU,FT,LV,5-HT3 receptor antagonist)
• Attended other clinical trial within 4 weeks
• Received transfusion of blood,related products or G-CSF within 15 days
• Received surgery within 4 weeks and the effect hadn't vanished
• Have diarrhea
• Have complication of active infection(infection caused fever higher than 38℃)
• Have complication of poor controlled hypercalcemia,hypertension,diabetes
• Have complication of severe ECG abnormal or other heart disease which will affect clinical treatment(including: cardiac dysfunction,myocardial infarction,angina)
• Have complication of severe pulmonary disease(including:interstitial pneumonia,pulmonary fibrosis,severe emphysema)
• Have complication of psychiatric disorder which will affect clinical treatment or have history of CNS disease
• Have complication of active gastrointestinal bleeding
• Have pleural effusion,ascites or pericardial effusion that need drainage
• Have complication of multiple bone metastasis
• Have severe complication(including:ileus,renal insufficiency,hepatic insufficiency,cerebrovascular disturbance)
• Have brain metastasis or suspicious brain metastasis
• Have active multiple primary cancer
• Female patients who are in pregnancy or lactation and patients who are not willing to take contraception measures
• Investigator judge not eligible to this trial