Metastatic Colorectal Cancer
Conditions
Interventions
experimental group:XELOXIRI/bevacizumab
Sponsors
Department of Medical Oncology, National Center/Cancer Hospital, China Academy of Medical Science and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patients with histologically confirmed matastatic colorectal adenocarcinoma; 1. Age 18-80 years; 2. Eastern Cooperation Oncology Group (ECOG) performance score( = 6 months before study enrollment; 6. No previous therapy for mCRC; 7. Adequate organ functions as assessed by the following laboratory requirements: Leukocytes >= 3.0x10^9/L, absolute neutrophil count >= 1.5 x 10^9/L, platelet count >= 100x 10^9/L, hemoglobin >= 9g/dL; serum bilirubin = 60ml/min. 8. An expected survival of at least 3 months; 9. Willingly provide written informed consent to study procedures.
Exclusion criteria
Exclusion criteria: 1. Patients with dysphagia, active peptic ulcer, intestinal obstruction, active gastrointestinal bleeding, peptic perforation, malabsorption syndrome or uncontrolled intestinal inflammatory diseases; 2. With a history of extensive enterotomy or pelvic radiation therapy; 3. Suffering from grade 2 or higher symptomatic peripheral neuropathy according to NCIC-CIG criteria; 4. Uncontrolled central nervous system metaatasis, disseminated intravascular coagulation or active infection; 5. With concurrent cancer distinct from colorectal adenocarcinoma except cured skin basal cell carcinoma and cervical carcinoma in situ; 6. Undergone an major operation, open biopsy or major traumatic injury within 28 days before study enrollment or have potential to receive major operation during the trial; 7. Received central venous access device within 2 days before study enrollment; 8. Any kind of concurrent cardiac disease with clinical meanings, such as cardiovascular accident, myocardial infarction, thromboembolism or hemorrhage within 6 months before enrollment, congestive heart failure 1g; 10. Have a tendency of bleeding or clotting; 11. With nasty open wounds, ulcers or fractures; 12. Current or recent treatment of anticoagulants, antiplatelet agent or nonsteroidal antiinflammatory drugs, while aspirin of daily dose less than 325mg is allowed. 13. With any illness or medical conditions that may jeopardize the patient's compliance or interfere the analyses or judgements of study results; 14. Pregnancy or lactation at the time of study entry; 15. With fertility but refuse to contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT;MTD;RP2D;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| AEs;PFS;OS;DCR;DOR;TTR;surgical rate in patients with liver-only metastases; | — |
Countries
China
Contacts
Public ContactLin Yang
Department of Medical Oncology, Cancer Hospital, China Academy of Medical Science and Peking Union Medical College
Outcome results
None listed