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.
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
Interventions
Drug | Synonyms | Arms |
---|
CIK | autologous cytokine-induced killer cells | CIK combined chemotherapy group |
chemotherapy | platinum combined doublets | CIK 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
Name | Type | Description | Interventions |
---|
CIK combined chemotherapy group | Experimental | autologous 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 group | Active Comparator | platinum 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. | |
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 |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | Henan Cancer Hospital |
Last Updated
May 12, 2021