A Multicenter Feasibility Study With S-1, Oxaliplatin and Oral Leucovorin (SOL) for the Patients With Untreated Metastatic Colorectal Cancer
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