Cytokine-induced Killer Cell Immunotherapy for Surgical Resected Stage III Colorectal Cancer Patients After Chemotherapy
NCT ID: NCT02280278
Last Updated: 2014-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
550 participants
INTERVENTIONAL
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CIK group
Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 8 cycles of CIK therapy in this group.
Radical surgery
Adjuvant chemotherapy
Cytokine-induced killer cell immunotherapy
Control group
Stage III Colon Cancer patients will only receive radical operation and adjuvant chemotherapy.
Radical surgery
Adjuvant chemotherapy
Interventions
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Radical surgery
Adjuvant chemotherapy
Cytokine-induced killer cell immunotherapy
Eligibility Criteria
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Inclusion Criteria
* Stage III colon cancer
* undergone complete resection of primary tumor
* Completed standard adjuvant chemotherapy
* within 120 days of completion of standard therapy
* ECOG performancer status 0-2
* Satisfactory haematological or biochemical functions (tests should be carried out within 8 weeks prior to randomisation): Results of clinical investigations carried out within 8 weeks prior to randomisation can be used in place of the required screening investigations. Patients with mild laboratory abnormalities can be included at the discretion by the site principal investigator, and after approval by ASCOLT Trial Management Group
* ANC ≥ 1.0 x 109/L
* Platelets ≥ 100 x 109/L
* Creatinine clearance ≥ 30 mL/min
* Total bilirubin ≤ 2.0 x the upper limit normal
* AST \& ALT ≤ 5 x the upper limit normal
* Completed the following investigations
* Completed the following investigations
Exclusion Criteria
* recently use of high dose glucocorticoid
* Uncontrolled hypertension (untreated systolic blood pressure \> 160 mmHg, or diastolic blood pressure \> 95 mmHg)
* History of recent cancers (except for colorectal cancers, non-melanoma skin cancers, basal cell carcinomas, squamous cell carcinomas) in the past 5 years
* Patient having known allergy to capecitabine or Oxaliplatin
* Pregnant, lactating
18 Years
70 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Xiao-Jun Wu
Professor
Principal Investigators
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Xiao-Jun Wu, Prof.
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Sun Yat-Sen University Cancer Center
Guagzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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5010010
Identifier Type: -
Identifier Source: org_study_id
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