Status:
UNKNOWN
A Clinical Study of Recombinant Human Vascular Endothelial Inhibitor in Combination With PRaG for Advanced Refractory Non-small Cell Lung Cancer
Lead Sponsor:
Second Affiliated Hospital of Soochow University
Conditions:
Advanced Solid Tumor
Refractory Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Exploring the efficacy and safety of recombinant human vascular endothelial inhibitor (Endo) in combination with Bragg therapy in advanced refractory non-small cell lung
Detailed Description
Radiotherapy: Start radiotherapy on the first day of treatment, as described in 6.2 above; GM-CSF treatment: GM-CSF 200 μg on the first day of treatment, administered subcutaneously daily for 7 day...
Eligibility Criteria
Inclusion
- Patients aged 18-75 years;
- Patients enrolled must be eligible for patients with recurrent or metastatic advanced non-small cell lung cancer, with a clear pathological diagnosis report or history of disease, with guidelines that do not clearly recommend standard treatment regimens or who are unable to tolerate standard treatment regimens, and with clear measurable metastatic lesions (\>1cm);
- No congestive heart failure, unstable angina, or unstable arrhythmia within the last 6 months.
- Patient activity status score of 0-3 on the Eastern Cooperative Oncology Group (ECOG) scale with life expectancy assessed at ≥3 months.
- No previous severe haematopoietic, cardiac, pulmonary, hepatic or renal abnormalities and immunodeficiency.
- Absolute T-lymphocyte values ≥ 0.5 times the lower limit of normal and neutrophils ≥ 1.0 x 109/L; AST and ALT ≤ 3.0 times the upper limit of normal (≤ 5.0 times the upper limit of normal for hepatocellular carcinoma/metastatic liver cancer); creatinine ≤ 3.0 times the upper limit of normal, 1 week prior to enrollment.
- Patients must have the ability to understand and voluntarily sign the informed consent form.
Exclusion
- Pregnant or breastfeeding women;
- Persons with a history of other malignant disease in the last 5 years, except cured skin cancer and carcinoma in situ of the cervix;
- Persons with a history of uncontrolled epilepsy, central nervous system disorders or psychiatric disorders whose clinical severity, as judged by the investigator, may prevent the signing of an informed consent or affect the patient's compliance with drug therapy;
- Clinically significant (i.e., active) cardiac disease such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmias requiring pharmacological intervention, or a history of myocardial infarction within the last 12 months;
- Persons requiring immunosuppressive therapy for organ transplantation;
- Known major active infection or, in the judgement of the investigator, major haematological, renal, metabolic, gastrointestinal, endocrine dysfunction or metabolic disorders, or other serious uncontrolled concomitant disease;
- Hypersensitivity to any investigational drug component;
- Persons with a history of immunodeficiency, including those who have tested positive for HIV or have other acquired or congenital immunodeficiency diseases, or a history of organ transplantation, or other immune-related diseases requiring long-term oral hormone therapy
- Persons with active tuberculosis infection;
- Those with interstitial lung disease or non-infectious pneumonia that may prevent the assessment of pulmonary toxicity associated with the study or the manager;
- Other conditions that, in the opinion of the investigator, are not suitable for enrolment.
Key Trial Info
Start Date :
June 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06047860
Start Date
June 16 2023
End Date
December 31 2024
Last Update
September 21 2023
Active Locations (1)
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1
The Second Affiliated Hospital of SchoowUniversity
Suzhou, China, 215004