Back to results

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

Primary Purpose

Lung Adenocarcinoma

Status

Terminated

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

CIK

chemotherapy

About this trial

This is an interventional treatment trial for Lung Adenocarcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
EML4-ALK fuse gene is negative and the detection of EML4-ALK is FISH or ventana IHC.
There should be at least one measurable lesions (by CT or MRI)
No other cancer history ( except skin squamous cell carcinoma after surgery)
Age between 18 and 75 years old
World health organization- Eastern Cooperative Oncology Group Performance Status 0-1
Life expectancy more than 3 months and can be followed-up
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.
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.
Men should take effective contraceptive measures from the beginning of therapy to one month after the last cycle of chemotherapy.
Willing to comply with the ban and constraints for this study protocol specified.
Informed consent and willing to participate in this study.

Exclusion Criteria:

Accepted other study drugs 30 days before the beginning of this study.
Brain metastases with clinical symptoms ( with exception of being controlled after radiation)
Active viral or bacterial infection and can't be controlled with appropriate anti-infection treatment
Known as HIV infection, syphilis serology reaction positive, active hepatitis B virus or hepatitis C virus infection
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.
Known allergy to any kind of component of study drugs
Active rheumatic diseases
Organ transplant recipients
Poor compliance
Pregnant women
Lactating women

Sites / Locations

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CIK combined chemotherapy group

chemotherapy group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

overall survival time

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

Secondary Outcome Measures

time to progression

time to progression points to from date of randomization until the date of first documented progression, up to 24 months

objective response rate

the partion of overall remission in total proportion

Full Information

NCT ID

NCT02621333

First Posted

November 25, 2015

Last Updated

May 10, 2021

Sponsor

Henan Cancer Hospital

Collaborators

Henan Provincial People's Hospital, Hebei Medical University Fourth Hospital, Shanxi Dayi Hospital, Tangshan People's Hospital, 150th Hospital of PLA, First Affiliated Hospital of Nanyang Medical College, Nanyang Central Hospital, First People's Hospital of Shangqiu, Anyang Regional Hospital, Puyang Oilfield General Hospital, Shenma Medical Group General Hospital, Jiaozuo Tumor Hospital, The 152th Central Hospital of PLA, Xinyang Central Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02621333

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Terminated

Why Stopped

As there are so many clinical trials in progress and the number of patients enrolled limited.

Study Start Date

October 2015 (Actual)

Primary Completion Date

September 2018 (Actual)

Study Completion Date

September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Henan Cancer Hospital

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

280 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CIK combined chemotherapy group

Arm Type

Experimental

Arm Description

Arm Title

chemotherapy group

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

CIK

Other Intervention Name(s)

autologous cytokine-induced killer cells

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

chemotherapy

Other Intervention Name(s)

platinum combined doublets

Intervention Description

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.

Primary Outcome Measure Information:

Title

overall survival time

Description

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

Secondary Outcome Measure Information:

Title

time to progression

Description

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

Title

objective response rate

Description

the partion of overall remission in total proportion

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. EML4-ALK fuse gene is negative and the detection of EML4-ALK is FISH or ventana IHC. There should be at least one measurable lesions (by CT or MRI) No other cancer history ( except skin squamous cell carcinoma after surgery) Age between 18 and 75 years old World health organization- Eastern Cooperative Oncology Group Performance Status 0-1 Life expectancy more than 3 months and can be followed-up 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. 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. Men should take effective contraceptive measures from the beginning of therapy to one month after the last cycle of chemotherapy. Willing to comply with the ban and constraints for this study protocol specified. Informed consent and willing to participate in this study. Exclusion Criteria: Accepted other study drugs 30 days before the beginning of this study. Brain metastases with clinical symptoms ( with exception of being controlled after radiation) Active viral or bacterial infection and can't be controlled with appropriate anti-infection treatment Known as HIV infection, syphilis serology reaction positive, active hepatitis B virus or hepatitis C virus infection 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. Known allergy to any kind of component of study drugs Active rheumatic diseases Organ transplant recipients Poor compliance Pregnant women Lactating women

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Quanli Gao, M.D.

Organizational Affiliation

Henan Cancer Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

City

ZhengZhou

State/Province

Henan

ZIP/Postal Code

450008

Country

China

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

terminated as the slow enrollment

Citations:

PubMed Identifier

22581306

Citation

Li R, Wang C, Liu L, Du C, Cao S, Yu J, Wang SE, Hao X, Ren X, Li H. Autologous cytokine-induced killer cell immunotherapy in lung cancer: a phase II clinical study. Cancer Immunol Immunother. 2012 Nov;61(11):2125-33. doi: 10.1007/s00262-012-1260-2. Epub 2012 May 13.

Results Reference

result

PubMed Identifier

21681372

Citation

Zhong R, Teng J, Han B, Zhong H. Dendritic cells combining with cytokine-induced killer cells synergize chemotherapy in patients with late-stage non-small cell lung cancer. Cancer Immunol Immunother. 2011 Oct;60(10):1497-502. doi: 10.1007/s00262-011-1060-0. Epub 2011 Jun 17.

Results Reference

result

PubMed Identifier

26013109

Citation

Wang S, Wang Z. Efficacy and safety of dendritic cells co-cultured with cytokine-induced killer cells immunotherapy for non-small-cell lung cancer. Int Immunopharmacol. 2015 Sep;28(1):22-8. doi: 10.1016/j.intimp.2015.05.021. Epub 2015 May 23.

Results Reference

result

PubMed Identifier

29562855

Citation

Zhao L, Li W, Wang Z, Yang Y, Zhang Y, Shang Y, Ren X, Gao Q. Survival benefit from RectroNectin-activated cytokine-induced killer cells combined with chemotherapy in advanced EGFR wild-type lung adenocarcinoma. Immunotherapy. 2018 Mar 1;10(6):501-510. doi: 10.2217/imt-2017-0140.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs