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Trial record 7 of 29121 for:    Immunologic Factors

SBRT Combination With rhGM-CSF and Tα1 for Stage IV NSCLC Patients Who Failed in Second-line Chemotherapy

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ClinicalTrials.gov Identifier: NCT02976740
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital of Xiamen University

Brief Summary:
The purpose of this study is to determine whether stereotactic body radiotherapy (SBRT) combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) and Thymosin Alpha 1 is safe, effective in the treatment of stage IV NSCLC patients who failed in second-line chemotherapy.

Condition or disease Intervention/treatment Phase
Lung Cancer Metastatic Radiation: SBRT Drug: Immunological Agent Drug: Immunological Factors Phase 2

Detailed Description:
Metastasis lesion of stage IV NSCLC will be treated with a SBRT of 50Gy/4-10F from day 1 to day 14 in one cycle. Subcutaneous injection of human recombined granulocyte-macrophage colony stimulating factor (125ug/m² per day) will be executed from day 1 to day 14 in this cycle. Another metastasis lesion will be treated likewise concurrently with rhGM-CSF in a consecutive cycle.Thymosin Alpha 1(1.6mg Biw) will be Subcutaneous injection from the fist week to the 12th weeks, Efficacy evaluation, especially abscopal effect evaluation, will be conducted at the end of therapy and every month after that. Adverse events will be recorded according to NCI-CTC version 4.03.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Multi-center Phase II Study: Assessment of the Safety and Abscopal Effects of SBRT Combination With rhGM-CSF and Thymosin Alpha 1 for Stage IV NSCLC Patients Who Failed in Second-line Chemotherapy
Study Start Date : November 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SBRT+GM-CSF+Tα1
Metastasis lesion will be treated with a SBRT of 50Gy/4-10F from day 1 to day 10 . Subcutaneous injection of Immunological Agent- human recombined granulocyte-macrophage colony stimulating factor (125ug/m² per day) will be executed from day 1 to day 14 in this cycle. Another metastasis lesion will be treated likewise concurrently with rhGM-CSF in a consecutive cycle. Subcutaneous injection of another Immunological Factors Thymosin Alpha 1(1.6mg Biw)will be executed from the fist WEEK to the 12th Weeks.
Radiation: SBRT
Stereotactic body radiotherapy A type of radiation therapy to the Metastasis lesion
Other Name: SABR

Drug: Immunological Agent
Subcutaneous injection of human recombined granulocyte-macrophage colony stimulating factor (125ug/m² per day) will be executed from day 1 to day 14 in this cycle. Another metastasis lesion will be treated likewise concurrently with rhGM-CSF in a consecutive cycle.
Other Name: rh GM-CSF

Drug: Immunological Factors
Thymosin Alpha 1(1.6mg Biw)will be executed from the fist Week to the 12th Weeks.
Other Name: Tα1




Primary Outcome Measures :
  1. abscopal effect rate [ Time Frame: at the time point of 4 weeks after completion of the combined treatment ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 1 year after completion of the combined treatment ]
  2. Incidence of Adverse events [ Time Frame: 1 year after completion of the combined treatment ]
  3. objective response rate [ Time Frame: 4 weeks after completion of the combined treatment ]
  4. Incidence of immune-related adverse events [ Time Frame: 1 year after completion of the combined treatment ]


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Ages Eligible for Study:   17 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Inclusion Criteria:

  1. Histologically proven non-small-cell lung cancer.
  2. Stage IV according to UICC stage system(version 7,2009).
  3. Progression after standard second-line chemotherapy.
  4. At least Three evaluable lesions among which at least two must be suitable for SBRT.
  5. ECOG performance status 0-2.
  6. Expected lifespan ≥3 months.
  7. Stable lab values:

    Hematological: Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets ≥100×109/L, Hemoglobin ≥9 g/dL Renal: Creatinine OR Measured or calculated creatinine clearance (CrCl) (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) ≤1.5× the upper limit of normal (ULN) OR ≥60 mL/min for patient with creatinine levels >1.5× institutional ULN Hepatic: Total bilirubin ≤1.5×ULN OR Direct bilirubin ≤ULN for patients with total bilirubin levels >1.5×ULN, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN OR ≤5×ULN for patients with liver metastases ,globulin≥20 g/L, albumin≥30 g/L.

  8. Female subjects must have a negative urine or serum pregnancy test within 72 hours prior to taking study drug if of childbearing potential.
  9. Able to understand and give written informed consent and comply with study procedures.

Exclusion Criteria:

  1. Any unstable systemic disease, including active infection, uncontrolled high blood pressure, unstable angina, newly observed angina pectoris within the past 3 months, congestive heart failure (New York heart association (NYHA) class II or higher), myocardial infarction onset six months before included into the group, and severe arrhythmia, liver, kidney, or metabolic disease in need of drug therapy, Including diabetes.
  2. Any clinical evidence suggests moderately severe chronic obstructive pulmonary disease (COPD) - [With COPD history or related risk factors, FEV1 / FVC < 70%, FEV1 < 80% estimated value, with or without chronic cough, sputum, dyspnea symptoms), active interstitial lung disease - ILD (FEV1 / FVC < 70%, FEV1 < 80% estimated value, carbon monoxide diffusion capacity in lung - DLCO < 40%, and high resolution CT (HRCT) confirmed as the diffuse pulmonary interstitial lesions] and other active pulmonary disease.
  3. Previously diagnosed with autoimmune diseases, including but not limited to systemic lupus erythematous, rheumatoid arthritis, systemic vasculitis, scleroderma, dermatomyositis, autoimmune hemolytic anemia and autoimmune liver disease, autoimmune thyroiditis.
  4. Human immunodeficiency virus (HIV) infection.
  5. Women in pregnancy or lactation .
  6. Medicine abusers(including alcohol, drugs or other addictive drugs abusers).
  7. Patients with mental illness, considered as "can't fully understand the issues of this research".
  8. Cancer history within 5 years apart from NSCLC before enrollment.
  9. Histologically confirmed small cell carcinoma or other non NSCLC compositions in the cancer tissue.
  10. Cancer treatment within 4 weeks, including but not limited to palliative surgery ,radiotherapy, chemotherapy and target therapy.
  11. Tumor related immunotherapy within 1 year, including but not limited to immune cell therapy, tumor vaccine therapy, immune check-point monoclonal antibody related treatment, and cytokines treatment except for GM-CSF.
  12. Allergy of rhGM-CSF/Tα1 and its accessories.
  13. Contraindications to GM-CSF/Tα1 treatment.
  14. Patients with unilateral lung.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02976740


Contacts
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Contact: Deng Chong, MD 86-05922139531 dengchongxm@163.com
Contact: Lin Qin, MD/PhD 86-05922139531 linqin03@163.com

Locations
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China, Fujian
First affiliated Hospital of Xiamen University Recruiting
Xiamen, Fujian, China, 361000
Contact: Deng Chong, MD    8605922139531    dengchongxm@163.com   
Contact: Lin Qin, MD/PhD    8605922139531    linqin06@163.com   
Principal Investigator: Deng Chong, MD         
Principal Investigator: Lin Qin, MD/PhD         
Principal Investigator: Ye Feng, MD         
Principal Investigator: An Hanxiang, MD/PhD         
Principal Investigator: Liu Qun, MD         
Sponsors and Collaborators
The First Affiliated Hospital of Xiamen University

Publications of Results:
Other Publications:

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Responsible Party: The First Affiliated Hospital of Xiamen University
ClinicalTrials.gov Identifier: NCT02976740     History of Changes
Other Study ID Numbers: KYZ2016-006
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The First Affiliated Hospital of Xiamen University:
lung cancer
SBRT
rhGM-CSF
Thymosin Alpha 1

Additional relevant MeSH terms:
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Sargramostim
Thymalfasin
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic