Clinical Trials /

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

NCT02621333

Description:

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.

Related Conditions:
  • Lung Adenocarcinoma
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: HenanCH003
  • NCT ID: NCT02621333

Conditions

  • Lung Adenocarcinoma

Interventions

DrugSynonymsArms
CIKautologous cytokine-induced killer cellsCIK combined chemotherapy group
chemotherapyplatinum combined doubletsCIK combined chemotherapy group

Purpose

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 Description

      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.
    

Trial Arms

NameTypeDescriptionInterventions
CIK combined chemotherapy groupExperimentalautologous CIK combined chemotherapy group Drugs: platinum combined doublets; After 3 or 4 days of chemotherapy, about 5×109 autologous cytokine-indued killer cells are transfused into the vein of patients in one hour.
  • chemotherapy
chemotherapy groupActive Comparatorplatinum combined doublets Drugs: 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.
  • chemotherapy

Eligibility Criteria

        Inclusion Criteria:

          1. Diagnosed as stage Ⅳ naive EGFR wild-type lung adenocarcinoma by image, tissue and/or
             cytology; or relapse after operation (if the patient received adjuvant chemotherapy
             and the interval between the last chemotherapy and relapse is at least six months. The
             detection method of EGFR mutation is ARMS.

          2. EML4-ALK fuse gene is negative and the detection of EML4-ALK is FISH or ventana IHC.

          3. There should be at least one measurable lesions (by CT or MRI)

          4. No other cancer history ( except skin squamous cell carcinoma after surgery)

          5. Age between 18 and 75 years old

          6. World health organization- Eastern Cooperative Oncology Group Performance Status 0-1

          7. Life expectancy more than 3 months and can be followed-up

          8. Patients must have adequate organ and marrow functions as defined below: white blood
             cells: more than 3.5×109/L, Neutrophils: more than 1.5×109/L, Platelets: more than
             80×109/L, Hemoglobin more than 90g/L, Serum total bilirubin less than 1.5 folds of the
             upper normal limit (ULN), Serum glutamic-oxal

             (o) acetic transaminase: less than 2.5×ULN (if there is liver metastasis less than
             5×ULN); Serum creatinine: less than 1.0×ULN, Prothrombin time, Active partial
             thromboplastin time, Fibrinogen, Thrombin time are in normal ranges.

          9. Women of child-bearing period must take effective contraceptive measures during all
             the time of study. During the period of study the results of blood and urine pregnancy
             test should be negative.

         10. Men should take effective contraceptive measures from the beginning of therapy to one
             month after the last cycle of chemotherapy.

         11. Willing to comply with the ban and constraints for this study protocol specified.

         12. Informed consent and willing to participate in this study.

        Exclusion Criteria:

          1. Accepted other study drugs 30 days before the beginning of this study.

          2. Brain metastases with clinical symptoms ( with exception of being controlled after
             radiation)

          3. Active viral or bacterial infection and can't be controlled with appropriate
             anti-infection treatment

          4. Known as HIV infection, syphilis serology reaction positive, active hepatitis B virus
             or hepatitis C virus infection

          5. Suffering from mental illness or other illness, such as heart or lung disease,
             diabetes, etc. that can not be controlled, and can not be coped with study treatment
             and monitoring requirements.

          6. Known allergy to any kind of component of study drugs

          7. Active rheumatic diseases

          8. Organ transplant recipients

          9. Poor compliance

         10. Pregnant women

         11. Lactating women
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:overall survival time
Time Frame:from the day of randomization to the day of death, up to 36 months
Safety Issue:
Description:overall survival time aims at from date of randomization until the date of death from any cause, up to 36 months

Secondary Outcome Measures

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

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Henan Cancer Hospital

Last Updated

December 2, 2015