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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
280
platinum combined doublets: Paclitaxel 175mg/m2 D1, or Docetaxel75mg/m2 D1, or Pemetrexed Disodium 500mg/m2,D1;combined cisplatin 25mg/m2,D1-3 or carboplatin AUC=5, D1. After 3 or 4 days of chemotherapy, about 5×109 autologous cytokine-induced killer cells are transfused into the vein of patients in one hour.
platinum combined doublets: Paclitaxel 175mg/m2 D1, or Docetaxel75mg/m2 D1, or Pemetrexed Disodium 500mg/m2,D1;combined cisplatin 25mg/m2,D1-3 or carboplatin AUC=5, D1.
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
Zhengzhou, Henan, China
overall survival time
overall survival time aims at from date of randomization until the date of death from any cause, up to 36 months
Time frame: from the day of randomization to the day of death, up to 36 months
time to progression
time to progression points to from date of randomization until the date of first documented progression, up to 24 months
Time frame: from the day of randomization to the day of first detecting progression, up to 24 months
objective response rate
the partion of overall remission in total proportion
Time frame: one year
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