Phase
Condition
Non-small Cell Lung Cancer
Treatment
PTC predicts the response to drug therapy in lung cancer patients
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age: ≥18 years and ≤80 years;
Non-small cell lung cancer diagnosed by pathology (including histology or cytology);
Having measurable lesions (according to RECIST 1.1 criteria, the long diameter of CTscan of tumour lesion is ≥10mm, the short diameter of CT scan of lymph node lesionis ≥15mm, the thickness of scanning layer is not more than 5mm, and the measurablelesion has not received local treatment such as radiotherapy, cryotherapy, etc.);
ECOG PS: 0-2 points;
Expected survival ≥ 3 months;
Adequate hepatic function, defined as total bilirubin levels ≤ 1.5 times the upperlimit of normal (ULN) and alanine aminotransferase (AST) and alanineaminotransferase (ALT) levels ≤ 2.5 times the ULN in all patients;
Adequate renal function, defined as creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula);
Adequate coagulation function, defined as International Normalised Ratio (INR) orProthrombin Time (PT) ≤ 1.5 times ULN; if the subject is on anticoagulant therapy,as long as the INR/PT is within the range formulated for the anticoagulant drug;
For female subjects of childbearing potential, a negative urine or serum pregnancytest should be presented within 3 days prior to receiving the first dose of studydrug, or a blood pregnancy test will be requested if the urine pregnancy test resultcannot be confirmed as negative;
If there is a risk of conception, male and female patients are required to usehighly effective contraception (i.e., a method with a failure rate of less than 1%per year) for at least 180 days after discontinuation of trial treatment; NOTE:Abstinence is acceptable as a method of contraception if abstinence is the subject'susual lifestyle and preferred method of contraception;
Subjects voluntarily enroll in the study, sign a written informed consent prior tothe implementation of any trial-related process, are compliant, and cooperate withfollow-up visits.
Exclusion
Exclusion Criteria:
Currently participating in an interventional clinical study treatment, or havereceived another investigational drug or investigational device within 4 weeks priorto the first dose;
Have received a proprietary medicine with an anti-tumor indication or animmunomodulatory drug (thymidine, interferon, interleukin, etc.) within 2 weeksprior to the first dose, or have received major surgical treatment within 3 weeksprior to the first dose;
Presence of active hemoptysis, active diverticulitis, abdominal abscess,gastrointestinal obstruction and peritoneal metastases requiring clinicalintervention;
Known or screening test findings of active central nervous system (CNS) metastasesand/or carcinomatous meningitis;
Has received a solid organ or blood system transplant;
Class III-IV congestive heart failure (New York Heart Association classification)with poorly controlled and clinically significant arrhythmias;
Any arterial thrombosis, embolism or ischemia such as myocardial infarction,unstable angina, cerebrovascular accident or transient ischemic attack within 6months prior to enrolment for treatment. History of deep vein thrombosis, pulmonaryembolism, or any other serious thromboembolism within 3 months prior to enrolment (implantable IV port or catheter-derived thrombosis, or superficial venousthrombosis are not considered "serious" thromboembolism);
Active autoimmune disease requiring systemic therapy (e.g., disease-modifying drugs,corticosteroids, or immunosuppressants) within 2 years prior to the first dose.Alternative therapies (e.g., thyroxine, insulin, or physiological doses ofcorticosteroids for adrenal or pituitary insufficiency) are not considered systemictherapy;
Patients requiring long-term systemic corticosteroids. Patients requiringintermittent use of bronchodilators, inhaled corticosteroids, or locally injectedcorticosteroids due to COPD, asthma may be enrolled;
Diagnosis of other malignancy within 5 years prior to the first dose, excludingradically treated basal cell carcinoma of the skin, squamous cell carcinoma of theskin, and/or radically resected carcinoma in situ, and if diagnosed with othermalignancy or lung cancer more than 5 years prior to the dose, pathological orcytological diagnosis of recurrent metastatic lesions is required;
Known psychiatric or substance abuse conditions that may have an impact oncompliance with the trial requirements;
Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2antibody positive), known syphilis infection (syphilis antibody positive), activetuberculosis;
untreated active hepatitis B; Note: Subjects with hepatitis B who meet the followingcriteria are also eligible for enrolment: HBV viral load must be <1000 copies/ml (200 IU/ml) or below the lower limit of detection prior to the first dose of drug,and subjects should be treated with anti-HBV therapy to avoid viral reactivation forthe entire duration of the study chemotherapeutic agent treatment. For subjects withanti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBVtherapy is not required but close monitoring of viral reactivation is needed;
Subjects with active HCV infection (HCV antibody positive and HCV-RNA levels abovethe lower limit of detection);
Live vaccination within 30 days prior to the first dose; NOTE: It is permissible toreceive injectable inactivated viral vaccine against seasonal influenza; however, itis not permissible to receive live attenuated influenza vaccine administeredintranasally;
The presence of abnormal results from a medical history, disease, treatment, orlaboratory that could interfere with the results of the trial, prevent the subjectfrom participating in the study throughout its duration, or where participation inthe study is not, in the opinion of the Investigator, in the best interest of thesubject;
Local or systemic disease, or secondary reactions to cancer, not due to malignancyand which may result in a higher medical risk and/or uncertainty in the evaluationof survival.
Persons who, in the opinion of the investigator, are not suitable for inclusion.
Study Design
Study Description
Connect with a study center
Shanghai Pulmonary Hospital
Shanghai 1796236, Shanghai Municipality 1796231 200433
ChinaActive - Recruiting

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