Efficacy of Adjuvant Cytokine-induced Killer Cells in Colon Cancer

Colonic Neoplasms Clinical Trial

— CIKCC  

Official title:

Efficacy of Adjuvant Immunotherapy With Cytokine-induced Killer Cells in Patients With Stage II/III Colon Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01929499
• Other study ID #: CIKCC
• Status: Not yet recruiting
• Phase: Phase 2
• First received: August 20, 2013
• Last updated: August 27, 2013
• Start date: September 2013
• Est. completion date: August 2019

Study information

• Verified date: August 2013
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: Yanjuan Zhu
• Phone: (+86)13902260217
• Email: zyjsophy[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. completion date: August 2019
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Neoplasms

Intervention

Biological:
• cytokine-induced killer cells

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Yanjuan Zhu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DFS (Disease free survival)	Patients who were recurrence free at the end of study or lost to follow-up were censored	Time elapsedelapsed from the date of surgery to either the date of recurrence or the date of last follow-up information,whichever come first, assessed up to 5 years.	No
Secondary	OS (overall survival)	Patients who were survival at the end of study or lost to follow-up were censored	Time elapsed from the date of surgery to either the date of death or the date of last follow-up information, whichever came first, assessed up to 5 years.	No
Secondary	Side effect	Any undesirable secondary effect which occurs in addition to the desired therapeutic effect of CIK or chemotherapy, during the period from the first cycle of chemotherapy or CIK infusion to the end of study. The side effects were described according to the NCI-CTCAE (National Cancer Institute-Common Terminology Criteria for Adverse Events)	Up to 2 years	Yes
Secondary	T lymphocyte subset	During the period of CIK infusion	Up to 6 months	No
Secondary	QoL (quality of life)	During the period of chemotherapy and CIK infusion	Up to 1 year	No