NCT03329664

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
2.3 years until next milestone

Study Start

First participant enrolled

February 9, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

March 15, 2021

Status Verified

March 1, 2021

Enrollment Period

1.6 years

First QC Date

October 30, 2017

Last Update Submit

March 11, 2021

Conditions

Colon Cancer Stage IV

Outcome Measures

Primary Outcomes (3)

  • 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

  • Progression-free Survival (PFS)

    The time from treatment initiation day to first documented progressive disease or death due to disease.

    2 years

  • Time to progression (TTP)

    the time from randomization until cancer progression, not including death.

    2 years

Secondary Outcomes (2)

  • Overall survival (OS)

    2 years

  • Patient quality of life

    each 3 months for 2 years

Study Arms (2)

CIK Intervention plus routine treatment

EXPERIMENTAL

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

Biological: Cytokine-induced killer cellOther: Chemotherapy AND/OR Radiation Therapy

Control

ACTIVE COMPARATOR

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

Other: Chemotherapy AND/OR Radiation Therapy

Interventions

Cytokine-induced killer cellBIOLOGICAL

Immune-cell therapy with CIK cells

Also known as: CIK
CIK Intervention plus routine treatment
Chemotherapy AND/OR Radiation TherapyOTHER

Routine treatments for colon cancer patients according to their stage

CIK Intervention plus routine treatmentControl

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gene Therapy Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Naser Ahmadbeigi, Ph.D

    Cell-based Therapies Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Naser Ahmadbeigi, Ph.D

CONTACT

+9821-82415103n-ahmadbeigi@sina.tums.ac.ir

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 6, 2017

Study Start

February 9, 2020

Primary Completion

September 1, 2021

Study Completion

January 1, 2022

Last Updated

March 15, 2021

Record last verified: 2021-03

Locations

IR(1)