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The Safety and Efficacy Test of Immuncell-LC to Treat Refractory Metastatic Colorectal Cancer

NCT03220984 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-07-21

No results posted yet for this study

Summary

This study aims to evaluate the safety and efficacy of Immuncell-LC, the adoptive immuntherapeutic agent composed of a CIK cell agent, to treat patients with metastatic colorectal cancer, which are refractory to the 3rd-line chemotherapeutic agents.

All enrolled patients received the 12 times of Immuncell-LC therapy: 8 times in every 1 week and 4 times in every 2 weeks.

Conditions

Interventions

BIOLOGICAL

Immuncell-LC intravenous infusion using a CIK cell agent

Patients with metastatic colorectal cancer, which is refractory to the 3rd-line chemotherapy are enrolled in this study. Enrolled patients receive a total of 12 times of Immuncell-LC therapy: 8 times in every 1 week and the next 4 times in every 2 weeks. The treatment responses of immuncell-LC are evaluated by radiologic findings (Abdomin-pelvic CT and Chest CT), immune-markers and a selorogic tumor marker (Carcinoembryologic antigen (CEA)) at the 8th week and 17th week. The safety of Immuncell-LC is evaluated by the results of serologic tests, vital signs, ECOG-PS and adverse events. The follow-up period is the 1 year after the enrolled date.

Sponsors & Collaborators

  • Gangnam Severance Hospital

    lead OTHER

Principal Investigators

  • Seung Hyuk Baik · Gangnam Severance Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-16
Primary Completion
2019-03-15
Completion
2019-03-15

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03220984 on ClinicalTrials.gov