Metastatic Colorectal Cancer
Conditions
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.
Interventions
BIOLOGICALImmuncell-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.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
South Korea
Outcome results
None listed