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

Phase 2

• Conditions: Metastatic Colorectal Cancer
• Interventions: Biological: Immuncell-LC intravenous infusion using a CIK cell agent

• Registration Number: NCT03220984
• Lead Sponsor: Gangnam Severance Hospital

Brief 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.

Detailed Description

Stage IV colorectal cancer(CRC) has poor survival rate in spite of the development of chemotherapeutic agents. It is regarded as a standard palliative chemotherapy using with both targeted agents and cytototic chemotherpeutic agents. However, it is still demanding to treat stage IV CRC patients, who are refractory responses in these chemotherapeutics. In addition, patients were suffered from the various adverse events by the repetive cytotoxic chemotherapies.

Study Timeline

• Study Start: 2017-03-16
• Status Verified: 2017-07
• Study First Submitted: 2017-07-14
• Study First Submitted QC: 2017-07-14
• Study First Posted: 2017-07-18
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-21
• Primary Completion: 2019-03-15
• Study Completion: 2019-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• At least 19 years old

• Clinical diagnosis of metastatic colon cancer or rectal cancer

• ECOG ≥ 2

• ASA ≤ 3

• Patients should meet below conditions by serologic test, kidney and liver function test: Re-evaluation is permitted during screening.

  • Absolute neutrophil count (ANC) ≥ 1500/μL
  • Hemoglobin level ≥ 9.0 g/dL
  • Platelet count >75,000/μL
  • BUN and serum Creatinine are less than or equal to 1.5 multiply normal upper-limit
  • AST and ALT are less than 2.5 multiply normal upper-limit (If a patients has liver metastases, AST and ALT are less than 5 times of normal upper-limits.)

Exclusion Criteria

• Patient who has disease history of immune deficiency or auto-immune disease (ex. Multiple sclerosis, arthritis rheumatism, Buerger's disease, and adolescent-occurred insulin dependent diabetes)
• Pateint who diagnosed immune-deficiency diseases
• Diagnosis of malignant tumor within 5 years before this clinical trial. (except for skin cancer, local prostate canter or carcinoma in situ of the cervix
• Patient who needs interventional therapy due to intestinal obstruction of obstructive jaundice
• Diagnosed status of infection or sepsis
• Uncontrolled hypertension or heart-failure
• Severe allergic history, which is diagnosed by sub-investigators
• Serious psychologic disease, which is diagnosed by sub-investigators
• Pregnant women, nursing mother or people who has intention of being preganant during the clinical test
• Patient who participated in other clinical trials within last 4 weeks before this trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Immunotherapy group	Immuncell-LC intravenous infusion using a CIK cell agent	All enrolled patients receive a total of 12 times of Immuncell-LC therapy

Primary Outcome Measures

Name	Time	Method
the disease control rate (DCR)	4 months (17 weeks)	To evaluate the disease control rate (DCR) : complete reponse(CR), partial response(PR), stable disease(SD).

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of