- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05792995
Foundation and Clinical About the Expression of PD-1 in Peripheral Blood T Lymphocytes
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 Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Hubei
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Yichang, Hubei, China, 443003
- Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immunomonotherapy plus Chemotherapy plus Anti-angiogenesis Therapy
Any first-line treatment that includes immunotherapy.
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Any treatment regimen that includes immunotherapy.
Other Names:
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Experimental: Chemotherapy plus Immunomonotherapy
Any first-line treatment that includes immunotherapy.
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Any treatment regimen that includes immunotherapy.
Other Names:
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Experimental: Immunomonotherapy plus Anti-angiogenesis Therapy
Any first-line treatment that includes immunotherapy.
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Any treatment regimen that includes immunotherapy.
Other Names:
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Experimental: Immunomonotherapy
Any first-line treatment that includes immunotherapy.
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Any treatment regimen that includes immunotherapy.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare Progression Free Survival (PFS) Regimen using RECIST 1.1.
Time Frame: approximately 24 months
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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.
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approximately 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare Overall Survival (OS)
Time Frame: approximately 24 months
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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.
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approximately 24 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Nivolumab
- Durvalumab
- Pembrolizumab
Other Study ID Numbers
- CTGU007
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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