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Foundation and Clinical About the Expression of PD-1 in Peripheral Blood T Lymphocytes

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Sindillimab
Sponsored by
Xin-Hua Xu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

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

Inclusion Criteria: Volunteer to participate in clinical research; fully understand and know the research and sign informed consent. Age ≥18 years, and ≤75years , either sex. Eastern Collaborative Oncology Group Performance status (ECOG PS) 0 ,1 or 2. Patients with NSCLC diagnosed by histopathology (according to the 8th edition of AJCC). Initial diagnosis patients unable to perform surgery. Normal hepatic function: total bilirubin≤1.5×normal upper limit (ULN); Alanine aminotransferase and Aspartate aminotransferase levels ≤2.5×ULN or ≤5×ULN if liver metastasis is present. Normal renal function :Creatinine ≤1.5×ULN or calculated creatinine clearance ≥45 mL/min (using Cockcroft/Gault formula to calculate ). Normal hematological function:absolute neutrophil count ≥1.5×109/L, platelet count ≥70×109/L, hemoglobin≥80g/L [no blood transfusion or erythropoietin (EPO) within 7 days] Dependency]. Has a life expectancy of at ≥3 months. EGFR and ALK were negative. Exclusion Criteria: ECOG PS >2. Patients who received radiotherapy, chemotherapy, monoclonal antibody and oral EGFR-TKI therapy within six months. Patients who are receiving any other investigational agents within 30 days prior to entering the study. History of other malignancies (except for cured cervical carcinoma in situ or skin basal cell carcinoma and other malignancies that have been cured for more than 5 years). Have no measurable lesion as defined by RECIST 1.1. Accompanied by other serious diseases, including but not limited to: Uncontrollable congestive heart failure (NYHA grade Ⅲ or Ⅳ), unstable angina, poorly controlled arrhythmia, uncontrolled moderate or above hypertension (SBP > 160mmhg or DBP > 100mmhg) ; Severe active infection; Uncontrollable diabetes (refers to the high fluctuation of blood glucose, the impact on patients' life and the frequent occurrence of hypotension despite the standard insulin treatment and frequent blood glucose monitoring) ; Mental illness affecting informed consent and / or program compliance. Those who are allergic to the drug or its components used in the program. Pregnancy (confirmed by hCG test in blood or urine) or lactating women, or childbearing age subjects are unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least 6 months after the last trial treatment. Those who are not considered suitable for the study by the researchers. Unwilling to participate in this study or unable to sign informed consent.

Sites / Locations

  • Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Immunomonotherapy plus Chemotherapy plus Anti-angiogenesis Therapy

Chemotherapy plus Immunomonotherapy

Immunomonotherapy plus Anti-angiogenesis Therapy

Immunomonotherapy

Arm Description

Any first-line treatment that includes immunotherapy.

Any first-line treatment that includes immunotherapy.

Any first-line treatment that includes immunotherapy.

Any first-line treatment that includes immunotherapy.

Outcomes

Primary Outcome Measures

Compare Progression Free Survival (PFS) Regimen using RECIST 1.1.
PFS was defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1.

Secondary Outcome Measures

Compare Overall Survival (OS)
Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.

Full Information

First Posted
March 11, 2023
Last Updated
March 29, 2023
Sponsor
Xin-Hua Xu
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1. Study Identification

Unique Protocol Identification Number
NCT05792995
Brief Title
Foundation and Clinical About the Expression of PD-1 in Peripheral Blood T Lymphocytes
Official Title
Foundation and Clinical About the Expression of PD-1 in Peripheral Blood T Lymphocytes and Its Prediction of Immune Efficacy of Patients With Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 21, 2021 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xin-Hua Xu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Providing more theoretical basis for the prediction of the efficacy of advanced NSCLC and helping select better advantaged population of NSCLC immunotherapy to maximize the benefits of patients By exploring the relationship between the changes of PD-1 expression in peripheral blood T lymphocytes and the clinical efficacy before and after the use of PD-1 / PD-L1 inhibitors.
Detailed Description
From the perspective of immunology, it is intended to explore whether the expression of PD-1 in peripheral blood T lymphocytes can be used as a reference index for selecting immune "+" therapy in patients with advanced HCC, and to clarify the relationship between the expression level of peripheral blood T lymphocytes and the survival data of patients receiving immune "+" therapy. And explore whether there is consistency between the expression level of PD-L1 and that of PD-L1 on patients. At the same time, to explore whether there is a correlation between the distribution of T cell subsets and the efficacy of immunotherapy, so as to provide a new theoretical basis for the clinical screening of the target population of immune "+" therapy and a new clinical screening index for the prognosis assessment of patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immunomonotherapy plus Chemotherapy plus Anti-angiogenesis Therapy
Arm Type
Experimental
Arm Description
Any first-line treatment that includes immunotherapy.
Arm Title
Chemotherapy plus Immunomonotherapy
Arm Type
Experimental
Arm Description
Any first-line treatment that includes immunotherapy.
Arm Title
Immunomonotherapy plus Anti-angiogenesis Therapy
Arm Type
Experimental
Arm Description
Any first-line treatment that includes immunotherapy.
Arm Title
Immunomonotherapy
Arm Type
Experimental
Arm Description
Any first-line treatment that includes immunotherapy.
Intervention Type
Drug
Intervention Name(s)
Sindillimab
Other Intervention Name(s)
Pembrolizumab, Nivolumab, Durvalumab
Intervention Description
Any treatment regimen that includes immunotherapy.
Primary Outcome Measure Information:
Title
Compare Progression Free Survival (PFS) Regimen using RECIST 1.1.
Description
PFS was defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1.
Time Frame
approximately 24 months
Secondary Outcome Measure Information:
Title
Compare Overall Survival (OS)
Description
Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.
Time Frame
approximately 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Volunteer to participate in clinical research; fully understand and know the research and sign informed consent. Age ≥18 years, and ≤75years , either sex. Eastern Collaborative Oncology Group Performance status (ECOG PS) 0 ,1 or 2. Patients with NSCLC diagnosed by histopathology (according to the 8th edition of AJCC). Initial diagnosis patients unable to perform surgery. Normal hepatic function: total bilirubin≤1.5×normal upper limit (ULN); Alanine aminotransferase and Aspartate aminotransferase levels ≤2.5×ULN or ≤5×ULN if liver metastasis is present. Normal renal function :Creatinine ≤1.5×ULN or calculated creatinine clearance ≥45 mL/min (using Cockcroft/Gault formula to calculate ). Normal hematological function:absolute neutrophil count ≥1.5×109/L, platelet count ≥70×109/L, hemoglobin≥80g/L [no blood transfusion or erythropoietin (EPO) within 7 days] Dependency]. Has a life expectancy of at ≥3 months. EGFR and ALK were negative. Exclusion Criteria: ECOG PS >2. Patients who received radiotherapy, chemotherapy, monoclonal antibody and oral EGFR-TKI therapy within six months. Patients who are receiving any other investigational agents within 30 days prior to entering the study. History of other malignancies (except for cured cervical carcinoma in situ or skin basal cell carcinoma and other malignancies that have been cured for more than 5 years). Have no measurable lesion as defined by RECIST 1.1. Accompanied by other serious diseases, including but not limited to: Uncontrollable congestive heart failure (NYHA grade Ⅲ or Ⅳ), unstable angina, poorly controlled arrhythmia, uncontrolled moderate or above hypertension (SBP > 160mmhg or DBP > 100mmhg) ; Severe active infection; Uncontrollable diabetes (refers to the high fluctuation of blood glucose, the impact on patients' life and the frequent occurrence of hypotension despite the standard insulin treatment and frequent blood glucose monitoring) ; Mental illness affecting informed consent and / or program compliance. Those who are allergic to the drug or its components used in the program. Pregnancy (confirmed by hCG test in blood or urine) or lactating women, or childbearing age subjects are unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least 6 months after the last trial treatment. Those who are not considered suitable for the study by the researchers. Unwilling to participate in this study or unable to sign informed consent.
Facility Information:
Facility Name
Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University
City
Yichang
State/Province
Hubei
ZIP/Postal Code
443003
Country
China

12. IPD Sharing Statement

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Foundation and Clinical About the Expression of PD-1 in Peripheral Blood T Lymphocytes

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