IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
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This study has been withdrawn prior to enrollment.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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 July 25, 2017