Autologous Killer cell therapy in colorectal cancer patients

Efficacy of ex vivo activated and expanded autologous killer cells for colorectal cancer patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170726035311N2

Enrollment

Registered

2018-11-21

Start date

2019-01-01

Completion date

Unknown

Last updated

2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage IV colon cancer. Malignant neoplasm of colon

Interventions

Intervention 1: Control group: Patients in Control Group will receive standard chemotherapy and will receive normal saline as a placebo. Intervention 2: Patients in the intervention group, in additio

Eligibility

Sex/Gender

All

Age

40 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with histologically confirmed colorectal cancer at stage IV, The male patient of = 40 and <60 years of age, Eastern Cooperative Oncology Group (ECOG) performance status 0-2, Adequate cardiac/renal/hepatic function, Adequate bone marrow function (blood cell count).

Exclusion criteria

Exclusion criteria: History positive test result for HIV, HBV, HCV, HTLV-1, syphilis. Presence of Active infections upon blood collection. Immunodeficiencies, autoimmunities,severe allergies, reviving immuno-suppression regimen. History of participating in other clinical trials. History of drug abuse.

Design outcomes

Primary

Measure	Time frame
The incidence percentage of adverse events (vomiting, pyrexia, headache, cough) following infusion. Timepoint: Measuring body temperature and clinical examination by physician before infusion, on the day of infusion and on days 7, 14 and 21 post infusion. Method of measurement: Thermometer, Questionnaire.;Percent of patients with progression-free survival (PFS). Timepoint: every 4 weeks during treatment, every 2-3 months after treatment, for 2 years. Method of measurement: CT, MRI, medical examination.;Time to progression (TTP). Timepoint: every 4 weeks during treatment, every 2-3 months after treatment, for 2 years. Method of measurement: CT, MRI, medical examination.	—

Measure

Time frame

The incidence percentage of adverse events (vomiting, pyrexia, headache, cough) following infusion. Timepoint: Measuring body temperature and clinical examination by physician before infusion, on the day of infusion and on days 7, 14 and 21 post infusion. Method of measurement: Thermometer, Questionnaire.;Percent of patients with progression-free survival (PFS). Timepoint: every 4 weeks during treatment, every 2-3 months after treatment, for 2 years. Method of measurement: CT, MRI, medical examination.;Time to progression (TTP). Timepoint: every 4 weeks during treatment, every 2-3 months after treatment, for 2 years. Method of measurement: CT, MRI, medical examination.

—

Secondary

Measure	Time frame
Overall survival (OS),. Timepoint: 2 years. Method of measurement: Kaplan-Meier estimator,.;Quality of Life. Timepoint: ?Every 3 month and for 2 years. Method of measurement: Questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Naser Ahmadbeigi

Tehran University of Medical Sciences, Digestive Disease Research Center, Shariati Hospital

n-ahmadbeigi@sina.tums.ac.ir+98 21 8802 1089

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026