colorectal cancer
Conditions
Interventions
Group 2:capecitabine combined with irinotecan and apatinib
Group 1:capecitabine combined with irinotecan
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. aged 18-75 years male and female; The expected survival time is more than 3 months; 2. Histopathology and / or cytology confirmed recurrent or metastatic colorectal cancer; 3. Confirmed by pathology with measurable lesions, (CT scan Long diameter of tumor=10mm, CT scan Long diameter of lymph node lesion=15mm, scan slice thickness>5mm); 4. Estimated survival time=3 mouths; 5. ECOG 0-2; 6. The main organ function is normal, and meet the following standards(patients has not using blood transfusion , blood products or GCF and other correction of hematopoietic stimulating factor within 14 days): (1) The standard of blood routine examination should be consistent: HB=90 g/L, ANC=1.5×10^9/L, PLT=100×10^9/L,WBC=3.5×10^9/L; (2) Biochemical tests should meet the following criteria: TBIL50ml/min. 7. Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib; 8. Patients voluntarily entered the study and signed informed consent form (ICF). 9.Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks; 10. Patients who had previously failed first-line systemic chemotherapy for advanced colorectal cancer; patients who had not received second-line standard treatment
Exclusion criteria
Exclusion criteria: 1. Previous or concurrent malignancies, with the exception of cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 2. Variety of factors affecting oral drugs (such as inability to swallow, chronic diarrhea, and intestinal obstruction); 3. A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc); 4. Patients who had history of hemoptysis within 2 months; 5. Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (++).Has melena and hematemesis in two months; 6. Coagulant function abnormality (INR > 1.5, APPT>1.5ULN), with bleeding tendency; 7. Patients with symptomatic central nervous system metastasis; 8. Patients with pregnant or planning a pregnancy; 9. History of psychiatric drugs abuse and can't quit or patients with mental disorders; 10. Less than 4 weeks from the last clinical trial; 11. The researchers think inappropriate. 12. Has been confirmed to be allergic to apatinib; 13. Have high blood pressure and antihypertensive drug treatment can not reduced to the normal range (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); With class II and above myocardial ischemia or myocardial infarction (including QTc lengthened men > 450 ms and women > 470 ms ), and class III-IV cardiac insufficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;Adverse reaction; | — |
Countries
China
Contacts
Public ContactShu Zhang
Shandong Cancer Hospital
Outcome results
None listed