NCT03084809

Chemotherapy Combined With CIK Treating Colon Cancer

Clinical Efficacy of Chemotherapy Combined With Cytokine-induced Killer in Treatment of Patients With Colon Cancer

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: China Meitan General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Over the past decade, advances in combination chemotherapy regimens for colorectal cancer have led to significant improvement in progression-free and overall survival. Cytokine-induced killer cells (CIK) is an auxiliary antitumor treatment. Research has demonstrated the median overall survival (OS) in patients received CIK combined with chemotherapy (5-Fluorouridine, leucovorin and oxaliplatin \[FOLFOX4\] plan) was significantly increased compared with that in patients received chemotherapy alone. Furthermore, there was a trend toward superior progression-free survival time (PFS) in patients received CIK combined with chemotherapy compared with that in patients received chemotherapy alone. The investigators aim to evaluate the clinical efficacy of chemotherapy (FOLFOX4) 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

• Colorectal Cancer
• Cytokine-induced Killer Cells
• Postoperative Complications
• Survival

Interventions

Type	Name	Description
DRUG	Cytokine-induced killer cells+ FOLFOX4	Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL 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 CIK cells were suspended with 100ml saline (containing 5ml 20% human serum albumin) and given continuously over 2 hours/ day for 3 days.
DRUG	FOLFOX4	Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL 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.

Timeline

• Start date: 2012-05-06
• Primary completion: 2014-09-15
• Completion: 2014-09-15
• First posted: 2017-03-21
• Last updated: 2017-03-21