Colorectal Cancer, Stage 4. Malignant neoplasm of colon, Malignant neoplasm of rectosigmoid junction, Malignant neoplasm of rectum, Malignant neoplasm of anus and anal canal
Conditions
Interventions
Intervention 1: Intervention group: Patients with colorectal cancer, stage 4 which receive chemotherapy and vaccine. The allogene vaccine (including three colon cancer cell lines) will be injected i
Sponsors
Esfahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Colorectal cancer, stage 4
Exclusion criteria
Exclusion criteria: History of any previous malignancy History of radiation therapy or chemotherapy History of more than one malignant colon cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measuring the levels of CA19-9. Timepoint: 6 months after the last vaccination. Method of measurement: via Elisa method.;Measuring the levels of CEA. Timepoint: 6 months after the last vaccination. Method of measurement: via Elisa method.;Measuring the levels of alanine aminotransferase. Timepoint: 6 months after the last vaccination. Method of measurement: via Elisa method.;Measuring the levels of aspartate aminotransferase. Timepoint: 6 months after the last vaccination. Method of measurement: via Elisa method.;Measuring the levels of alkaline phosphatase. Timepoint: 6 months after the last vaccination. Method of measurement: via Elisa method.;Measuring the levels of glutamyl tarnspeptidase. Timepoint: 6 months after the last vaccination. Method of measurement: via Elisa method.;Investigation of tumor formation. Timepoint: 6 months after the last vaccination. Method of measurement: via colonoscopy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of overall survival. Timepoint: Overall survival will be assay 2 years after vaccination. Method of measurement: Overall survival will be detected by lifespan after vaccination.;Evaluation of quality of life. Timepoint: Score of quality of life will be assay after third and sixth vaccinations and also 6 and 12 months after sixth vaccination. Method of measurement: via quality of life questionnaire.;Gastrointestinal adverse effects. Timepoint: 12 and 48 hours, 2 week and 6 month after sixth vaccination. Method of measurement: adverse effects of vaccine will be detected by physician.;Renal adverse effects. Timepoint: 12 and 48 hours, 2 week and 6 month after sixth vaccination. Method of measurement: adverse effects of vaccine will be detected by physician.;Hepatic adverse effects. Timepoint: 12 and 48 hours, 2 week and 6 month after sixth vaccination. Method of measurement: adverse effects of vaccine will be detected by physician.;Cardiac adverse effects. Timepoint: 12 and 48 hours, 2 week and 6 month after sixth vaccination. Method of measurement: adverse effects of vaccine will be detected by physician.;Respiratory adverse effects. Timepoint: 12 and 48 hours, 2 week and 6 month after sixth vaccination. Method of measurement: adverse effects of vaccine will be detected by physician.;Neurological adverse effects. Timepoint: 12 and 48 hours, 2 week and 6 month after sixth vaccination. Method of measurement: adverse effects of vaccine will be detected by physician.;Skin adverse effects. Timepoint: 12 and 48 hours, 2 week and 6 month after sixth vaccination. Method of measurement: adverse effects of vaccine will be detected by physician.;Musculoskeletal adverse effects. Timepoint: 12 and 48 hours, 2 week and 6 month after sixth vaccination. Method of measurement: adverse effects of vaccine will be detected by physician.;Joint adverse effects. Timepoint: 12 and 48 hours, 2 week and 6 month after sixth vaccination. Method of measurement: adverse effects of vacci | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Hassan Emami
Esfahan University of Medical Sciences
Outcome results
None listed