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

Metastatic Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03220984
• Other study ID #: 3-2016-0346
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: July 14, 2017
• Last updated: July 18, 2017
• Start date: March 16, 2017
• Est. completion date: March 15, 2019

Study information

• Verified date: July 2017
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 28
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)