colorectal cancer
Conditions
Interventions
control group:Irinotecan was given intravenously at week 1, week 3 and week 5, 180 mg / m2
Retetrasse was given intravenous drip of 2 mg / m2 for 1 day at 1, 3 and 5 weeks
Concurrent radiotherapy: IMRT external radiotherapy.
Experimental group:Irinotecan was given intravenously at week 1, week 3 and week 5, 180 mg / m2
Bevacizumab was given intravenously for 1 day at week 1, 3 and 5
Sponsors
The Second Affiliated Hospital, Medical School of Xi'an Jiao Tong University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patients with primary focus of colorectal cancer and diagnosed as recurrence or metastasis are not suitable to use oxaliplatin and fluorouracil again; 2. There are evaluable lesions, and the lesions have radiotherapy indications; 3. There was no other metastasis in the field; 4. The age is 18-75 years old, regardless of gender; 5. Karnofsky physical condition score >= 70; 6. The phenotype of UGT1A1 * 28 gene was 6 / 6 or 6 / 7; 7. The baseline blood routine test and biochemical indexes of the subjects met the following criteria: hemoglobin >= 90g / L; absolute neutrophil count (ANC) >= 1.5 x 10^9 / L; platelet >= 100 x 10^9 / L; ALT and AST = 30g / L; 8. Be able to comply with the protocol during the study; 9. Sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. For those who have a history of uncontrolled epilepsy, central nervous system diseases or mental disorders, the clinical severity of the patients should be judged by the researchers, which may hinder the signing of informed consent or affect the compliance of patients with oral drugs; 3. Clinically serious (i.e. active) heart disease, such as symptomatic coronary heart disease, NYHA class II or more congestive heart failure, or serious arrhythmia requiring drug intervention, or a history of myocardial infarction in the last 12 months; 4. Organ transplantation needs immunosuppressive therapy; 5. Serious uncontrolled repeated infection or other serious uncontrolled concomitant diseases; 6. UGT1A1 gene phenotype was 7 / 7; 7. Allergic to any ingredient of the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Overall Survival;Disease Control Rate;Quality of life score;Drug safety; | — |
Countries
China
Contacts
Public ContactMinghua Bai
Department of Radiotherapy, the Second Affiliated Hospital, Medical School of Xi’an Jiao tong University; Department of Radiotherapy, Cancer Hospital Affiliated to Fudan University
Outcome results
None listed