Clinical trial NCT03220984: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: the disease control rate (DCR)
timeFrame: 4 months (17 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: Gangnam Severance Hospital
name: Seung Hyuk Baik
role: PRINCIPAL_INVESTIGATOR
References: