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CIK Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC)
This study has been withdrawn prior to enrollment.
(Few patients would like to participate ,since CIK cell transfusion was a new treatment and its efficacy was doubted.)
Sponsor:
Sun Yat-sen University
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01533727
First received: February 12, 2012
Last updated: December 5, 2013
Last verified: February 2012
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Purpose
Non - small cell lung cancer ( NSCLC ) accounts for more than 80% of lung cancer. The main treatment for early stage patients is surgical resection, but about 30% -70% patients will relapse. Postoperative chemotherapy is the major systemic treatment for surgical resection NSCLC patients. However, data show only 5-10% improvement in overall survival with systemic adjuvant chemotherapy. It is necessary to further improve the survival time of patients with lung cancer. Biological treatment is becoming a new treatment modality for Cancer following with surgery, radiotherapy and chemotherapy, and has been confirmed as an effective adjuvant treatment in comprehensive cancer treatment. Cytokine induced killer cells ( CIK) characterized as fast amplification, strong anti-cancer activity and broad anti-tumor spectrum is most widely used and thought to be the first choice for the new generation of anti-tumor adoptive immunotherapy. This Phase II study is investigating the efficacy of Autologous Cytokine-Induced Killer Cell Transfusion plus Chemotherapy as adjuvant therapy for stage IB-IIIA NSCLC.
| Condition | Intervention | Phase |
|---|---|---|
| Non-small Cell Lung Cancer | Drug: Autologous CIK Transfusion plus Chemotherapy Drug: chemotherapy alone | Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Li Zhang, Sun Yat-sen University:
Primary Outcome Measures:
- the relapse rate [ Time Frame: 30 months ]
| Enrollment: | 0 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | December 2020 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A
Autologous CIK Transfusion plus Chemotherapy
|
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
|
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;
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01533727
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533727
Locations
| China, Guangdong | |
| Sun Yat-sen University Cancer Center | |
| Guangzhou, Guangdong, China, 510060 | |
Sponsors and Collaborators
Sun Yat-sen University
Investigators
| Principal Investigator: | Li Zhang, MD | Sun Yat-sen University |
More Information
| Responsible Party: | Li Zhang, Professor, Sun Yat-sen University |
| ClinicalTrials.gov Identifier: | NCT01533727 History of Changes |
| Other Study ID Numbers: |
2010014 |
| Study First Received: | February 12, 2012 |
| Last Updated: | December 5, 2013 |
Keywords provided by Li Zhang, Sun Yat-sen University:
|
Cytokine-Induced Killer Cell NSCLC adjuvant therapy |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on September 19, 2017