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

Primary Purpose

Metastatic Colorectal Cancer

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Immuncell-LC intravenous infusion using a CIK cell agent

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Gangnam Severance Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Immunotherapy group

Arm Description

All enrolled patients receive a total of 12 times of Immuncell-LC therapy

Outcomes

Primary Outcome Measures

the disease control rate (DCR)

To evaluate the disease control rate (DCR) : complete reponse(CR), partial response(PR), stable disease(SD).

Secondary Outcome Measures

Full Information

NCT ID

NCT03220984

First Posted

July 14, 2017

Last Updated

July 18, 2017

Sponsor

Gangnam Severance Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03220984

Brief Title

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

Official Title

Open-label, Single Center, Phase Ⅱ Clinical Trial to Evaluate Safety and Efficacy of Immuncell-LC in the Patients for Refractory Metastatic Colorectal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

March 16, 2017 (Actual)

Primary Completion Date

March 15, 2019 (Anticipated)

Study Completion Date

March 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gangnam Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Colorectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Immunotherapy group

Arm Type

Experimental

Arm Description

All enrolled patients receive a total of 12 times of Immuncell-LC therapy

Intervention Type

Biological

Intervention Name(s)

Immuncell-LC intravenous infusion using a CIK cell agent

Intervention Description

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.

Primary Outcome Measure Information:

Title

the disease control rate (DCR)

Description

To evaluate the disease control rate (DCR) : complete reponse(CR), partial response(PR), stable disease(SD).

Time Frame

4 months (17 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Seung Hyuk Baik

Organizational Affiliation

Gangnam Severance Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gangnam Severance Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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