Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immuncell-LC intravenous infusion using a CIK cell agent | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Immunotherapy group
- description
- All enrolled patients receive a total of 12 times of Immuncell-LC therapy
- interventionNames
- Biological: Immuncell-LC intravenous infusion using a CIK cell agent
Primary outcomes (1)
- measure
- the disease control rate (DCR)
- timeFrame
- 4 months (17 weeks)
- description
- To evaluate the disease control rate (DCR) : complete reponse(CR), partial response(PR), stable disease(SD).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available