CIK Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC)
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ClinicalTrials.gov Identifier: NCT01533727 |
Recruitment Status :
Withdrawn
(Few patients would like to participate ,since CIK cell transfusion was a new treatment and its efficacy was doubted.)
First Posted : February 15, 2012
Last Update Posted : December 9, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-small Cell Lung Cancer | Drug: Autologous CIK Transfusion plus Chemotherapy Drug: chemotherapy alone | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2,Open-label Study of Autologous Cytokine-Induced Killer Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer |
Study Start Date : | August 2011 |
Estimated Primary Completion Date : | December 2017 |
Estimated Study Completion Date : | December 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Group A
Autologous CIK Transfusion plus Chemotherapy
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Drug: Autologous CIK Transfusion plus Chemotherapy
vinorelbine 25-30mg/m2 d1, d8 q3w; DDP 75mg/m2 d1 q3w; pemetrexed 500mg/m2 d1 q3w; carboplatin AUC 5/6 q3w; CIK infusion D14 q3w |
Active Comparator: Group B
chemotherapy alone
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Drug: chemotherapy alone
vinorelbine 25-30mg/m2 d1, d8 q3w; DDP 75mg/m2 d1 q3w; pemetrexed 500mg/m2 d1 q3w; carboplatin AUC 5/6 q3w; |
- the relapse rate [ Time Frame: 30 months ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Stage IB-IIIA post-surgery NSCLC patients with histologically confirmed.
- with an Eastern CooperativeOncology Group performance status of 0 or 1,
- at least 18 years of age
- adequate bone marrow reserve and organ function including calculated creatinine clearance 45 mL/min based on the standard Cockcroft and Gault formula
- patients had fully recovered from its acute effects.
Exclusion Criteria:
- HIV positive
- autoimmune disease
- immune deficiency disorder
- organ transplantation
- received high dose glucocorticoid or other immune depressant within 4 weeks
- active clinically serious infections (> grade 2 NCI-CTC version 3.0)
- life threatening medical condition

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533727
China, Guangdong | |
Sun Yat-sen University Cancer Center | |
Guangzhou, Guangdong, China, 510060 |
Principal Investigator: | Li Zhang, MD | Sun Yat-sen University |
Responsible Party: | Li Zhang, Professor, Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT01533727 |
Other Study ID Numbers: |
2010014 |
First Posted: | February 15, 2012 Key Record Dates |
Last Update Posted: | December 9, 2013 |
Last Verified: | February 2012 |
Cytokine-Induced Killer Cell NSCLC adjuvant therapy |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |