Efficacy of Adjuvant Cytokine-induced Killer Cells in Colon Cancer (CIKCC)

Yanjuan Zhu

Status and phase: Unknown; Phase 2

Conditions: Colonic Neoplasms

Treatments: Biological: cytokine-induced killer cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01929499

CIKCC

Details and patient eligibility

About

It has been reported that the immune status of patients with cancer were suppressed, especially those after surgery and adjuvant chemotherapy. Thus, immunotherapy may decrease the recurrence rate after surgery. CIK cells transfusion has been reported as an effect therapy in advanced cancers. In another retrospective study, investigators found that adjuvant CIK therapy would prolong the disease-free survival (DFS) for colorectal cancer patients.

The purpose of this study is to determine wether adjuvant immunotherapy with CIK cells in patients with colon cancer after operation will prolong DFS, and overall survival (OS).

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Colon cancer in stage III or stage II with high risk after R0 resection
• Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1;
• Life expectancy of at least 3 months;
• Normal bone marrow, liver, renal, heart and lung function;
• Age between 18-80;
• Patients who provided written informed consent for this study

Exclusion criteria

• With uncontrolled other malignant tumors;
• With uncontrolled infection or tubercle bacillus (TB) or underlying diseases that were severe or life threatening;
• Patients who need to treat with radiotherapy;
• Patients who accepted other immunotherapy
• With sever mental disease or disease with central nervous system (CNS);
• With the history of organ transplantation, including bone marrow transplantation or stem cell transplantation;
• Patients with auto immune diseases;
• pregnant or lactating.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 3 patient groups

synchronous CIK group

Experimental group

Description:

After colectomy, patients will accept chemotherapy combined with cytokine-induced killer cells (CIK) therapy synchronously for 6 months. For CapeOx regimen: 3×109 CIK cells on days 1-3; Oxaliplatin 130mg/m2 on day 7; Capecitabine 1000mg/m2 twice daily on days 7-20; Repeat every 3 weeks for 6-8 cycles. For mFolfox6 regimen: Oxaliplatin 85mg/m2 IV over 2 hours on day 1; Leucovorin 400mg/m2 IV over 2 hours on day 1; 5-FU 400mg/m2 IV bolus on day 1, then 2400mg/m2 IV continuous infusion over 46-48 hous; 3×109 CIK cells on days 9-11; Oxaliplatin 85mg/m2 IV over 2 hours on day 15; Leucovorin 400mg/m2 IV over 2 hours on day 15; 5-fluorouracil (5-FU) 400mg/m2 IV bolus on day 15, then 2400mg/m2 IV continuous infusion over 46-48 hours; Repeat every 4 weeks for 5-6 cycles.

Treatment:

Biological: cytokine-induced killer cells

sequence CIK group

Experimental group

Description:

After colectomy, patients will accept adjuvant chemotherapy for 6 months, that is 6-8 cycles of CapeOX regimens (the same as those in arm A), or 10-12 cycles of mFolfox6 regimens(the same as those in arm A), followed by 6-8 cycles of cytokine-induced killer cells (CIK) therapy at least 2 weeks later.

Treatment:

Biological: cytokine-induced killer cells

control group

No Intervention group

Description:

After colectomy, patients will accept adjuvant chemotherapy for 6 months, that is 6-8 cycles of CapeOX regimens (the same as those in arm A), or 10-12 cycles of mFolfox6 regimens （the same as those in arm A）.