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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01929499
Other study ID # CIKCC
Secondary ID
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


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
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