Clinical Trial: Chemotherapy Combined Autologous Cytokine-induced Killer Cells in Naive Stage IV EGFR-wild Type Lung Adenocarcinoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Chemotherapy Combined Autologous Cytokine-induced Killer Cells in Naive Stage IV EGFR-wild Type Lung Adenocarcinoma: A Prospective, Randomised, Open, Multicenter Phase 

Brief Summary: This is a prospective, randomized, open, multicenter phase Ⅱ study to evaluate the efficacy of cytokine-induced killer cells combined chemotherapy in stage Ⅳ naive EGFR wild-type lung adenocarcinoma.

Detailed Summary: There is still no great improvement in advanced EGFR wild-type lung adenocarcinoma although great progress was made in treatment of non-small cell lung cancer. It's necessary to explore the treatment mode of this kind of patients. As the progress was made in tumor immunity and immunotherapy, more and more cancer therapists accept the treatment model of chemotherapy combined immunotherapy. And now chemotherapy combined autologous CIK cells is one kind of common treatment model in some countries. Investigators try to evaluate the efficacy and safety of this kind of treatment model in patients with stage Ⅳ naive EGFR wild-type lung adenocarcinoma.
Sponsor: Henan Cancer Hospital

Current Primary Outcome: overall survival time [ Time Frame: from the day of randomization to the day of death, up to 36 months ]

overall survival time aims at from date of randomization until the date of death from any cause, up to 36 months


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • time to progression [ Time Frame: from the day of randomization to the day of first detecting progression, up to 24 months ]
    time to progression points to from date of randomization until the date of first documented progression, up to 24 months
  • objective response rate [ Time Frame: one year ]
    the partion of overall remission in total proportion
  • quality of life [ Time Frame: one year ]


Original Secondary Outcome: Same as current

Information By: Henan Cancer Hospital

Dates:
Date Received: November 25, 2015
Date Started: October 2015
Date Completion: September 2018
Last Updated: December 2, 2015
Last Verified: December 2015