NCT03360630

Anti-PD-1 Alone or Combined With Autologous Cell Therapy in Advanced NSCLC

Autologous Dendritic Cell-cytokine Induced Killer Cell Immunotherapy Combined Anti-PD1 in Advanced NSCLC: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A randomized controlled study to compared the clinical effects and safety of immunotherapy with dendritic cells and cytokine-induced killer cells administered with anti-PD-1 antibody in advanced NSCLC.

Conditions

• Lung Cancer
• Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	Anti-PD-1 plus DC-CIK	Patients will receive pembrolizumab 100mg every three weeks until disease progression, unacceptable toxicity or patient refusal. DC-CIK Immunotherapy: Mononuclear cells were collected aseptically with blood cell separator composition apheresis, and cultured DC-CIK cells for 10-14 days. Cells were infused back to the patients in 3 times via intravenous infusion .Patients will received at least 2 cycles of DC-CIK Immunotherapy along with 4 dosage of anti-PD-1 antibody treatment. If the evaluation of the treatment is partial response or stable disease, additional cycles were eligible.
BIOLOGICAL	Anti-PD-1 alone	Patients will receive pembrolizumab 100mg every three weeks until disease progression, unacceptable toxicity or patient refusal.

Timeline

• Start date: 2016-11-01
• Primary completion: 2022-12-31
• Completion: 2023-06-01
• First posted: 2017-12-04
• Last updated: 2024-02-07

Locations

1 site across 1 country: China