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

NCT03220984 | Unknown Phase 2 DMC

• 1 other identifier: 3-2016-0346
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Immunotherapy group

EXPERIMENTAL

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

Biological: Immuncell-LC intravenous infusion using a CIK cell agent

Interventions

Immuncell-LC intravenous infusion using a CIK cell agent BIOLOGICAL

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.

Immunotherapy group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Seung Hyuk Baik

  Gangnam Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 18, 2017
• Study Start: March 16, 2017
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

KR (1)