Trial | NCT03329664  Report issue

Title

Autologous Killer Cell Therapy in Colon Cancer Patients
Safety and Efficacy of ex Vivo Activated and Expanded Autologous Cytokine-induced Killer Cells for Colon Cancer Patients

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    20
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 Started
Feb 09
2020
Primary Completion
Sep 30
2021
Anticipated
Study Completion
Jan 31
2022
Anticipated
Last Update
Mar 15
2021

Biological Cytokine-induced killer cell

Immune-cell therapy with CIK cells

  • Other names: CIK

Other Chemotherapy AND/OR Radiation Therapy

Routine treatments for colon cancer patients according to their stage

CIK Intervention plus routine treatment Experimental

Patients who receive their routine treatment (chemotherapy, radiation therapy) + Cytokine-induced killer cell infusion

Control Active Comparator

Patients who receive routine treatments only (chemotherapy, radiation therapy)

Criteria 

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
No Results Posted