colorectal cancer
Conditions
Interventions
Experimental group:Apatinib combination with Capeox / Folfiri chemotherapy
Control group:Capeox / Folfiri chemotherapy
Sponsors
Chongqing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patiens with a pathological diagnosis of recurrence/metastasis advanced colorectal cancer (AJCC 2016 TNM Staging Phase IV); 2. Aged = 18 years old male and female; 3. ECOG PS0-2 points; 4. The expected lifetime of patients should be equal to or more than 3 months; 5. The main viscera function of patients must be normal, and should meet the following requirements: 1) blood routine examination meeting the standards:ANC=1.5×10^9/L; PLT=80×10^9/L; Hb=90g/L(no blood transfusion and blood components support within 14 days, not using G-CSF and other hematopoietic stimulating factor correction); 2) blood biochemical examination meeting the following standards: TBIL<1.5×ULNALTAST<2.5×ULN, hepatic metastasis ALT, AST < 5 x ULNBUN and Cr=1×ULN, endogenous creatinine clearance =50 ml/min (Cockcroft - Gault formula); 6. Women of childbearing age must have taken reliable contraceptive measures or have performed a pregnancy test (serum or urine) within 7 days prior to enrollment, and the result is negative, during the test and the last 8 weeks after experimental patients must be used appropriate methods of contraception, or surgery sterilization; 7. Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure; 8. Genetic testing confirmed KRAS gene mutation in colorectal cancer specimens (Not suitable for cetuximab)or the patient refuses genetic testing or can't get the specimens needed for genetic testing; 9. Patients who are not suitable treated with bevacizumab, or the patient refused to use bevacizumab infusion therapy.
Exclusion criteria
Exclusion criteria: 1. Active brain metastasis, cancerous meningitis, spinal cord compression (Patients who have no symptoms and is not needed to receive therapy before 21 days may participate in this trial, but need to be confirmed by MRI\CT or venography that no hematencephalon symptom); 2. Uncontrolled hypertension(systolic pressure = 140 mmHg and/or diastolic pressure = 90 mm Hg) even though two or more than two hypotensive agents application; 3. Patients who suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias.Grade III-IV cardiac insufficiency according to New York Heart Association(NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)<50%; 4. Coagulation disfunction.or Known inherited and acquired hemorrhagic and thromboplastic possibility; 5. Within 4 weeks of major surgery and/or injures, fractures, ulceration; 6. Significant factors that influence the ingestion and absorption of medicine (Such as unable to swallow, chronic diarrhea and intestinal obstruction); 7. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess = 6 months; 8. Urine protein=++, or 24h urine protein quantitation=1.0g; 9. History of psychiatric drugs abuse and not be abstinent, or dysphrenia; 10. Pregnant or lactating women; Patients with fertility unwilling or unable to take effective contraceptive measures; 11. Other conditions regimented at investigators' discretion; 12. Genetic testing confirmed there is no KRAS gene mutation (Wild type)in colorectal cancer specimenpatients require cetuximab treatment; 13. Patients requiring bevacizumab treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR; | — |
Countries
China
Contacts
Public ContactSunHao
Chongqing Cancer Hospital Ethics Committee
Outcome results
None listed