CIK Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC)

Phase 2

Withdrawn

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Autologous CIK Transfusion plus Chemotherapy; Drug: chemotherapy alone

• Registration Number: NCT01533727
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Status Verified: 2012-02
• Study First Submitted: 2012-02-12
• Study First Submitted QC: 2012-02-14
• Study First Posted: 2012-02-15
• Last Update Submitted: 2013-12-05
• Last Update Posted: 2013-12-09
• Primary Completion: 2017-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Stage IB-IIIA post-surgery NSCLC patients with histologically confirmed.
2. with an Eastern CooperativeOncology Group performance status of 0 or 1,
3. at least 18 years of age
4. adequate bone marrow reserve and organ function including calculated creatinine clearance 45 mL/min based on the standard Cockcroft and Gault formula
5. patients had fully recovered from its acute effects.

Exclusion Criteria

1. HIV positive
2. autoimmune disease
3. immune deficiency disorder
4. organ transplantation
5. received high dose glucocorticoid or other immune depressant within 4 weeks
6. active clinically serious infections (> grade 2 NCI-CTC version 3.0)
7. life threatening medical condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Autologous CIK Transfusion plus Chemotherapy	Autologous CIK Transfusion plus Chemotherapy
Group B	chemotherapy alone	chemotherapy alone

Primary Outcome Measures

Name	Time	Method
the relapse rate	30 months

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China