Clinical trial · Interventional
Chemotherapy Combined With CIK Treating Colon Cancer
Clinical Efficacy of Chemotherapy Combined With Cytokine-induced Killer in Treatment of Patients With Colon Cancer
NCT03084809CI-TRIAL-00026552completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Cytokine-induced killer cells (CIK) is an auxiliary antitumor treatment. The investigators aim to evaluate the clinical efficacy of chemotherapy combined with CIK in the treatment of postoperative colorectal cancer patients. And to provide useful reference for the clinical application of CIK in colorectal cancer patients.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Cytokine-induced Killer Cells | — | UNRESOLVED | — |
| Postoperative Complications | — | UNRESOLVED | — |
| Survival | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytokine-induced killer cells+ FOLFOX4 | Drug | — | UNRESOLVED |
| FOLFOX4 | Drug | FOLFOX-4 Regimen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cytokine-induced killer cells + FOLFOX4
- description
- Cytokine-induced killer cells + FOLFOX4 intervention: Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL 5% dextrose in water (D5W); Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags; Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours.The treatment is given for 4-6 cycles, every 3 weeks. Collected cytokine-induced killer cells (CIK) cells were suspended with 100ml saline (containing 5ml 20% human serum albumin) and given continuously over 2 hours/ day for 3 days.
- interventionNames
- Drug: Cytokine-induced killer cells+ FOLFOX4
- type
- EXPERIMENTAL
- label
- FOLFOX4
- description
- FOLFOX4 intervention: Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL 5% dextrose in water (D5W); Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags; Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours. The treatment is given for 4-6 cycles, every 3 weeks.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 78 Years
Show eligibility criteria text
Inclusion Criteria: 1. Tumor, Nodes, Metastasis (TNM) stage of II or III; 2. Patients received radical resection of colon cancer; 3. Pathological diagnosis of adenocarcinoma; 4. Patients not received radiotherapy and chemotherapy before surgery; 5. The preoperative examination confirmed without systemic metastasis; 6. Patient has the Karnofsky score more than 70 points; 7. Subjects signed informed consent. Exclusion Criteria: 1. Patients who was serious allergy to any of the ingredients of drugs used in this study; 2. Patients who unable to comply with the treatment plan or research program; 3. Patients with severe systemic disease that the researchers judged will be unable to complete the study; 4. Patients have severe heart disease, such as myocardial infarction within 6 months; 5. Patients who have received chemotherapy or systemic antitumor therapy (such as monoclonal antibody therapy); 6. Patients received radiotherapy; 7. Having other malignant tumors in the last 5 years, but not including who has been cured through surgery and survived 5 year of disease-free; 8. Any unstable systemic diseases (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction, serious arrhythmias, liver, kidney or metabolic diseases within six months). 9. Patients who do not get effective treatment of inflammation, eye infections or predisposing factors; 10. Physical examination or laboratory findings evidence reasonable doubt who is ill or use of related drugs could affect the study; 11. Patients with serious active infections; 12. Woman who are pregnant or lactating.
References
Publications (0)
Data not yet available
No reference posted for this study.