Ignite Creation Date:
2024-05-06 @ 2:30 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04331626
Status:
UNKNOWN
Last Update Posted:
2020-04-02
First Post:
2020-03-31
Brief Title:
Low-dose Gemcitabine Combined With Nivolumab for Second-line and Above Line Treatment of NSCLC
Sponsor:
Henan Cancer Hospital
Organization:
Henan Cancer Hospital
Study Overview
Official Title:
An Exploratory Clinical Study of Low-dose Gemcitabine Combined With Nivolumab for Second-line and Higher-line Treatment of Driving Gene-negative Non-small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2019-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In recent years immunotherapy research has made great progress especially the immunocheckpoint inhibitors represented by anti-pd-1 antibody have shown good efficacy in the treatment of malignant tumors and some patients can achieve long-term survival However despite the encouraging clinical data only a small number of people have benefited Therefore how to further improve the efficacy of immunotherapy and expand the benefit population has become the focus of this field
The applicant was previously published in Oncoimmunology 2017 E1331807 pointed out in the above article MDSC is a group of immunosuppressive cells the number of this group of cells in the body of cancer patients is more than normal its presence affects the proliferation activation and function of T cells is one of the important factors affecting the efficacy of immunocheckpoint inhibitors Therefore ideal drugs used in combination with immunocheckpoint inhibitors should meet the following conditions first they can kill or inactivate tumor cells to release tumor-specific or associated antigens Second MDSC and other immunosuppressive cells can be eliminated Third the number and function of T cells were not affected
Gemcitabine is a synthetic antimetabolic tumor drug widely used in the treatment of locally advanced or metastatic non-small cell lung cancer Myelosuppression is the dose - limiting toxicity of gemcitabine which includes lymphocytopenia Therefore if the commonly used clinical dose gemcitabine is used in combination with pd-1 antibody the effect of pd-1 antibody will be affected due to the reduction of lymphocytes caused by gemcitabine Therefore we speculated that the reduced-dose treatment of gemcitabine combined with pd-1 antibody might have synergistic anti-tumor effect on the second-line and above second-line treatment of non-small cell lung cancer with negative driver gene and the adverse reactions were relatively mild
This study is a phase IV open non-randomized single-arm single-center study to investigate the safety and efficacy of half-dose gemcitabine combined with pd-1 antibody in second-line and above treatment of non-small cell lung cancer patients with negative driver genes Fifty subjects will be enrolled in this study The primary endpoint of the study was ORR while secondary endpoints included DCR PFS and OS
The applicant was previously published in Oncoimmunology 2017 E1331807 pointed out in the above article MDSC is a group of immunosuppressive cells the number of this group of cells in the body of cancer patients is more than normal its presence affects the proliferation activation and function of T cells is one of the important factors affecting the efficacy of immunocheckpoint inhibitors Therefore ideal drugs used in combination with immunocheckpoint inhibitors should meet the following conditions first they can kill or inactivate tumor cells to release tumor-specific or associated antigens Second MDSC and other immunosuppressive cells can be eliminated Third the number and function of T cells were not affected
Gemcitabine is a synthetic antimetabolic tumor drug widely used in the treatment of locally advanced or metastatic non-small cell lung cancer Myelosuppression is the dose - limiting toxicity of gemcitabine which includes lymphocytopenia Therefore if the commonly used clinical dose gemcitabine is used in combination with pd-1 antibody the effect of pd-1 antibody will be affected due to the reduction of lymphocytes caused by gemcitabine Therefore we speculated that the reduced-dose treatment of gemcitabine combined with pd-1 antibody might have synergistic anti-tumor effect on the second-line and above second-line treatment of non-small cell lung cancer with negative driver gene and the adverse reactions were relatively mild
This study is a phase IV open non-randomized single-arm single-center study to investigate the safety and efficacy of half-dose gemcitabine combined with pd-1 antibody in second-line and above treatment of non-small cell lung cancer patients with negative driver genes Fifty subjects will be enrolled in this study The primary endpoint of the study was ORR while secondary endpoints included DCR PFS and OS
Detailed Description:
In recent years immunotherapy research has made great progress especially the immunocheckpoint inhibitors represented by anti-pd-1 antibody have shown good efficacy in the treatment of malignant tumors and some patients can achieve long-term survival However despite the encouraging clinical data only a small number of people have benefited Therefore how to further improve the efficacy of immunotherapy and expand the benefit population has become the focus of this field
Conventional view holds that chemotherapeutic drugs work by directly killing tumor cells In recent years with the in-depth understanding of immunity people have realized that the anti-cancer effect of chemotherapy drugs depends on the bodys sound immune system and chemotherapy drugs have been more and more recognized as an immune regulator However it should be noted that the combination of drugs may not achieve the desired results or even the opposite
The applicant was previously published in Oncoimmunology 2017 E1331807 pointed out in the above article MDSC is a group of immunosuppressive cells the number of this group of cells in the body of cancer patients is more than normal its presence affects the proliferation activation and function of T cells is one of the important factors affecting the efficacy of immunocheckpoint inhibitors Therefore ideal drugs used in combination with immunocheckpoint inhibitors should meet the following conditions first they can kill or inactivate tumor cells to release tumor-specific or associated antigens Second MDSC and other immunosuppressive cells can be eliminated Third the number and function of T cells were not affected
Gemcitabine is a synthetic antimetabolic tumor drug widely used in the treatment of locally advanced or metastatic non-small cell lung cancer Myelosuppression is the dose - limiting toxicity of gemcitabine which includes lymphocytopenia Therefore if the commonly used clinical dose gemcitabine is used in combination with pd-1 antibody the effect of pd-1 antibody will be affected due to the reduction of lymphocytes caused by gemcitabine Therefore we speculated that the reduced-dose treatment of gemcitabine combined with pd-1 antibody might have synergistic anti-tumor effect on the second-line and above second-line treatment of non-small cell lung cancer with negative driver gene and the adverse reactions were relatively mild
This study is a phase IV open non-randomized single-arm single-center study to investigate the safety and efficacy of half-dose gemcitabine combined with pd-1 antibody in second-line and above treatment of non-small cell lung cancer patients with negative driver genes Fifty subjects will be enrolled in this study The primary endpoint of the study was objective efficiency ORR while secondary endpoints included disease control rate DCR disease-free progression PFS and overall survival OS
Conventional view holds that chemotherapeutic drugs work by directly killing tumor cells In recent years with the in-depth understanding of immunity people have realized that the anti-cancer effect of chemotherapy drugs depends on the bodys sound immune system and chemotherapy drugs have been more and more recognized as an immune regulator However it should be noted that the combination of drugs may not achieve the desired results or even the opposite
The applicant was previously published in Oncoimmunology 2017 E1331807 pointed out in the above article MDSC is a group of immunosuppressive cells the number of this group of cells in the body of cancer patients is more than normal its presence affects the proliferation activation and function of T cells is one of the important factors affecting the efficacy of immunocheckpoint inhibitors Therefore ideal drugs used in combination with immunocheckpoint inhibitors should meet the following conditions first they can kill or inactivate tumor cells to release tumor-specific or associated antigens Second MDSC and other immunosuppressive cells can be eliminated Third the number and function of T cells were not affected
Gemcitabine is a synthetic antimetabolic tumor drug widely used in the treatment of locally advanced or metastatic non-small cell lung cancer Myelosuppression is the dose - limiting toxicity of gemcitabine which includes lymphocytopenia Therefore if the commonly used clinical dose gemcitabine is used in combination with pd-1 antibody the effect of pd-1 antibody will be affected due to the reduction of lymphocytes caused by gemcitabine Therefore we speculated that the reduced-dose treatment of gemcitabine combined with pd-1 antibody might have synergistic anti-tumor effect on the second-line and above second-line treatment of non-small cell lung cancer with negative driver gene and the adverse reactions were relatively mild
This study is a phase IV open non-randomized single-arm single-center study to investigate the safety and efficacy of half-dose gemcitabine combined with pd-1 antibody in second-line and above treatment of non-small cell lung cancer patients with negative driver genes Fifty subjects will be enrolled in this study The primary endpoint of the study was objective efficiency ORR while secondary endpoints included disease control rate DCR disease-free progression PFS and overall survival OS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None