Colon Cancer Stage IV Clinical Trial
Official title:
Safety and Efficacy of ex Vivo Activated and Expanded Autologous Cytokine-induced Killer Cells for Colon Cancer Patients
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | January 2022 |
Est. primary completion date | September 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: - Patients with histologically confirmed colorectal cancer at stage IV - ECOG performance status 0-2 - Adequate cardiac/renal/hepatic function - Adequate bone marrow function (blood cell count) Exclusion Criteria: - Patients that have received prior chemotherapy or immune cell therapy - Patients that have previously participated in another clinical trial - History of positive test result for HIV, HBV, HCV, HTLV-1, syphilis - Presence of Active infections - Patients with immunodeficiencies, autoimmunities, or severe allergies - Receiving immunosuppressive regimens |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Gene Therapy Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences | Tehran |
Lead Sponsor | Collaborator |
---|---|
Sabz Biomedicals | Digestive Diseases Research Institute, Tehran University of Medical Sciences, Iran, Ministry of Health and Medical Education |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of administering CIK cells plus chemotherapy | Patients will be continually assessed for unexpected adverse events or unexpected early mortality 30 days post infusion | one month post infusion | |
Primary | Progression-free Survival (PFS) | The time from treatment initiation day to first documented progressive disease or death due to disease. | 2 years | |
Primary | Time to progression (TTP) | the time from randomization until cancer progression, not including death. | 2 years | |
Secondary | Overall survival (OS) | The length of time that the patients are still alive at a defined period of time after treatment | 2 years | |
Secondary | Patient quality of life | Quality of patients enrolling in the study assessed using EORTC-CR29 questionnaire | each 3 months for 2 years |
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