colorectal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically-confirmed inoperable colorectal adenocarcinoma; 2. Aged =18 years; 3. ECOG 0-1; 4. Life expectancy of at least 90 days; 5. Withdrawal from first-line chemotherapy (regardless of containing molecular-targeted drugs) for metastatic colorectal cancer due to intolerable toxicity or progressive disease, or relapse within 180 days after the last dose of adjuvant chemotherapy; 6. Adequate organ function according to following laboratory values obtained within 14 days before enrolment (excluding patients who received blood transfusions or hematopoietic growth factors within 14 days before the laboratory test) Neutrophil count: =1500/mm3 Platelet count: =10.0 x 104/mm3 Hemoglobin: =9.0 g/dL Total bilirubin: =1.5 mg/dL AST, ALT: =100 IU/L (=200 IU/I if liver metastases present) Serum creatinine: =1.5 mg/dL; 7. Measurable or nonmeasurable disease based on the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); 8. Adequate coagulation function [International Normalized Ratio (INR) =1.5 and Partial Thromboplastin Time (PTT) or activated PTT (aPTT) =1.5 x upper limit of normal (ULN)) and no clinically significant active bleeding.
Exclusion criteria
Exclusion criteria: 1. History of other malignancy with a disease-free interval +2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR;QoL; | — |
Countries
China
Contacts
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology