Colorectal Cancer
Conditions
Interventions
Oxaliplatin 130mg/m2 i.v. (day1) Bevaciumab 7.5mg/Kg i.v. (day1) Capecitabine2,000mg/m2,p.o.(day1-14) Autologous alfa/beta T cells i.v. to be repeated every 3 weeks
Sponsors
Fukuoka University School of Medicine Department of Gastroenterological Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed colorectal cancer 2. Treatment plan of XELOX(+-bevacizumab) for colorectal cancer 3.No prior chemotherapy for colorectal cancer 4.Performance Status: 0-1 (ECOG criteria) 5.Age: 20 years old or older 6.Signed written informed consent 7.Vital organ functions are preserved within 14 days prior to entry Neutrophil:>=1,500/mm3 Platelet:>=75,000/mm3 Hb.:>= 8.0 mg/dl T.bil.:<= 2.0 mg/dl Creatinin:<=2.0mg/dl
Exclusion criteria
Exclusion criteria: 1.Prior severe drug allerg 2.Presence of active infection 3.Multiple malignancy within 5 years disease free interval 4.Uncontrolled hypertension or diabetes 5. Severe peripheral nerve disorder 6.Chronic systemic treatment of corticosteroid 7.Nursing or pregnant females, or females or males with female partners who are planning to pregnancy 8.Inadequate for study enrollment by the physician 9.Anti-HIV antibody(+),Anti-HTLV-1 antibody(+)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy - Progression-free survival - Overall survival - Response rate - Immunological responses | — |
Countries
Japan
Contacts
Public ContactYoichiro Yoshida
Fukuoka University School of Medicine Gastroenterological Surgery
Outcome results
None listed