This study aims to evaluate the safety and efficacy of activated and expanded autologous cytokine-killer cells in controlling disease recurrence in colon cancer patients with liver metastasis. 20 patients with confirmed stage IV colon carcinoma with metastasis will be assigned into two groups. Patients in both groups will receive the same therapeutic regimen as usual. Patients in one group additionally will be treated with a single infusion of autologous killer cells that had been previously prepared from peripheral blood.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
20
Immune-cell therapy with CIK cells
Routine treatments for colon cancer patients according to their stage
Gene Therapy Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences
Tehran, Iran
RECRUITINGSafety of administering CIK cells plus chemotherapy
Patients will be continually assessed for unexpected adverse events or unexpected early mortality 30 days post infusion
Time frame: one month post infusion
Progression-free Survival (PFS)
The time from treatment initiation day to first documented progressive disease or death due to disease.
Time frame: 2 years
Time to progression (TTP)
the time from randomization until cancer progression, not including death.
Time frame: 2 years
Overall survival (OS)
The length of time that the patients are still alive at a defined period of time after treatment
Time frame: 2 years
Patient quality of life
Quality of patients enrolling in the study assessed using EORTC-CR29 questionnaire
Time frame: each 3 months for 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.