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

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

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.

Study Overview

• Status: Unknown
• Conditions: Metastatic Colorectal Cancer
• Intervention / Treatment: Biological: Immuncell-LC intravenous infusion using a CIK cell agent

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 Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Immunotherapy group; All enrolled patients receive a total of 12 times of Immuncell-LC therapy

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital
• Investigators: Principal Investigator: Seung Hyuk Baik, Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 16, 2017
• Primary Completion (ANTICIPATED): March 15, 2019
• Study Completion (ANTICIPATED): March 15, 2019

Study Registration Dates

• First Submitted: July 14, 2017
• First Submitted That Met QC Criteria: July 14, 2017
• First Posted (ACTUAL): July 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 3-2016-0346

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No