Efficacy of Adjuvant Cytokine-induced Killer Cells in Colon Cancer

Phase 2UnknownNCT01929499

Yanjuan Zhu210 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

210

Conditions

Colonic Neoplasms

Interventions

cytokine-induced killer cellsBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

DFS (Disease free survival)

Patients who were recurrence free at the end of study or lost to follow-up were censored

Time frame: 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.

Secondary Outcomes

OS (overall survival)

Patients who were survival at the end of study or lost to follow-up were censored

Time frame: 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.

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)

Time frame: Up to 2 years

T lymphocyte subset

During the period of CIK infusion

Time frame: Up to 6 months

QoL (quality of life)

During the period of chemotherapy and CIK infusion

Time frame: Up to 1 year

Central Contacts

Yanjuan Zhu

CONTACT

(+86)13902260217 zyjsophy@hotmail.com

Haibo Zhang, MD

CONTACT

(+86)13724123615 haibozh@aliyun.com

Data from ClinicalTrials.gov

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