Evaluation of safty of personalized Colon Cancer Cell Vaccine
Phase 1
Not yet recruiting
- Conditions
- Colorectal Cancer.Malignant neoplasm of colon, Malignant neoplasm of rectosigmoid junction, Malignant neoplasm of rectum, Malignant neoplasm of anus and anal canal,C18, C19,
- Registration Number
- IRCT20210620051632N1
- Lead Sponsor
- Esfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Colorectal cancer, stage 4
Exclusion Criteria
History of any previous malignancy
History of radiation therapy or chemotherapy
History of more than one malignant colon cancer.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Investigation of tumor markers levels (CEA, CA19-9) and liver enzymes and no new tumor formation. Timepoint: 6 months after the last vaccination. Method of measurement: Measure the umor markers levels (CEA, CA19-9) and liver enzymes concentration via Elisa method, and assay the new tumor formation via colonoscopy.
- Secondary Outcome Measures
Name Time Method Overall survival and Score of quality of life; Gastrointestinal, renal, hepatic, cardiac, respiratory, neurological, skin, musculoskeletal, joint and allergic adverse effects. Timepoint: Overall survival will be assay 2 years after vaccination. Score of quality of life will be assay after third and sixth vaccinations and also 6 and 12 months after sixth vaccination. Gastrointestinal, renal, hepatic, cardiac, respiratory, neurological, skin, musculoskeletal, joint and allergic adverse effects, will be assay 12 and 48 hours, 2 week and 6 month after sixth vaccination. Method of measurement: Overall survival will be detected by Lifespan after vaccination. Quality of life will be detected via quality of life questionnaire. adverse effects of vaccine will be detected by physician.