None listed
Conditions
Interventions
Drug : Study design &Intervention schedule
This study is a multicenter, phase 2, single arm study. Individual investigators are allowed to choose 2nd line chemotherapy agents,bevacizumab, cetuximab,af
Sponsors
Hallym University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed metastatic colorectal cancer patients eligible for 2nd line palliative chemotherapy 2. Patients who have measurable disease as defined by Response Evaluation Criteria In Solid Tumors Guideline version 1.1 (RECIST 1.1) (No prior radiation therapy to measurable lesion) 3. Patients who failed 1st line chemotherapy or recurred during adjuvant chemotherapy or recurred within 6 months of completion of adjuvant chemotherapy 4. Age = 19 years 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 6. Life expectancy = 12 weeks 7. Adequate hematopoietic function (hemoglobin = 9.0 g/dL; absolute neutrophil count = 1,500/µL; platelet count = 100,000/µL) 8. Adequate hepatic function (total bilirubin < 2.5xULN, transaminase < 2.5xULN, < 5xULN, if liver metastases are present) 9. Adequate renal function (serum creatinine = 1.5 mg/dL, or creatinine clearance = 50 mL/min) 10. Patients should sign a written informed consent before study entry
Exclusion criteria
Exclusion criteria: . Exclusion criteria 1. Other malignancy within the past 5 years except cured non-melanomatous skin cancer or carcinoma in situof the cervix. 2. History of clinically significant heart disease within the past 12 months (eg, refractory congestive heart failure, symptomatic coronary artery diseases, arrhythmia, myocardial infarction). 3. Serious concurrent infection requiring antibiotics. 4. Pregnant or breastfeeding women. 5. Patients with evidence of CNS metastasis. Patients with uncontrolled seizure or CNS disorder or psychiatric disorder. 6. History of allogenic transplantation (eg, kidney, liver transplantation) 7. Patient or caregiver who does not understand or consent to the written consent. 8. Patients receiving a concomitant treatment with drugs interacting with study drug. 9. Patients who have allergy to study drug. 10. Patients with malabsorption syndrome based on domestic authorization of the study drug. 11. Patients who need to take medication that affects the immune response (eg, long-term steroid administration or other immunosuppressants). However, short-term steroid usage for symptom relief associated with cancer is permissible. 12. Patients who participated in other clinical trials within 4 weeks before enrollment and taking other clinical trial drugs. 13. Patients who received radiation therapy within 8 weeks prior to enrollment. 14. Patients who have been identified not to be suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate;Progression-free survival;Overall survival;Immune response | — |
Countries
Korea, Republic of
Contacts
Public ContactDAE YOUNG ZANG
Hallym University Medical Center
Outcome results
None listed