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

NCT02621333 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2021-05-12

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

CIK

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.

DRUG

chemotherapy

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.

Sponsors & Collaborators

  • Henan Provincial People's Hospital

    collaborator OTHER

  • Hebei Medical University Fourth Hospital

    collaborator OTHER

  • Shanxi Dayi Hospital

    collaborator OTHER

  • Tangshan People's Hospital

    collaborator OTHER

  • 150th Hospital of PLA

    collaborator OTHER_GOV

  • First Affiliated Hospital of Nanyang Medical College

    collaborator OTHER

  • Nanyang Central Hospital

    collaborator OTHER

  • First People's Hospital of Shangqiu

    collaborator OTHER

  • Anyang Regional Hospital

    collaborator OTHER

  • Puyang Oilfield General Hospital

    collaborator OTHER

  • Shenma Medical Group General Hospital

    collaborator OTHER

  • Jiaozuo Tumor Hospital

    collaborator UNKNOWN

  • The 152th Central Hospital of PLA

    collaborator OTHER

  • Xinyang Central Hospital

    collaborator OTHER

  • Henan Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • Quanli Gao, M.D. · Henan Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02621333 on ClinicalTrials.gov