The Study of Envafolimab Combined With Concurrent Chemoradiotherapy In LS-SCLC

Korábbi kezelés

• Patients who have previously been treated with inhibitors of immune regulatory points (CTLA-4, PD-1, PD-L1, etc.).
• Patients may require long-term use of immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive doses for comorbidities.
• Simultaneously using other investigational drugs or in other clinical trials.

Más betegség

• Patients with non-small cell lung cancer or mixed components of small cell lung cancer in histopathology.
• Patients with extensive stage small cell lung cancer (ES-SCLC).
• Merge malignant pleural effusion and pericardial effusion.
• Merge patients with more severe underlying diseases.
• Patients with immunodeficiency disorders and a history of organ transplantation (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, nephritis, hyperthyroidism, hypothyroidism; vitiligo or childhood asthma. Patients who have completely relieved and do not require any intervention after adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included).
• Patients with significantly reduced heart, liver, lung, kidney, and bone marrow function.
• Serious and uncontrolled internal diseases and infections.
• A history of allergies to etoposide, cisplatin, or any excipients.

Laborértékek

• Those whose laboratory test values during the screening period before enrollment do not meet relevant standards.

Egyéb

• Pregnant and lactating women.
• Refusal or inability to sign informed consent form for participation in the experiment.
• Researchers have determined that patients are not suitable to participate in the study and are unlikely to comply with the study procedures, limitations, and requirements.

• The result of histopathological or cytological diagnosis is small cell lung cancer.
• Diagnosed as limited stage by imaging examination (lesion limited to half chest and one radiotherapy field, without malignant pleural or pericardial effusion); And at least one measurable lesion that meets the RECIST 1.1 standard.
• Have not received systematic treatment in the past, and initially underwent 2 cycles of etoposide+cisplatin/carboplatin induction therapy.
• Age 18-75 years old, male or non pregnant female.
• The expected survival period is>3 months.
• ECOG score 0-1.
• Weight>30 kilograms.
• All patients underwent chest CT, head MRI, abdominal CT or MRI, and whole body bone scan before treatment to clarify.
• Hematological indicators: white blood cell (WBC) count ≥ 4 * 109/L, absolute neutrophil count (ANC) ≥ 1.5 * 109/L, hemoglobin (Hb) level>100 g/L, platelet (Plt) count>100 * 109/L, serum creatinine (Cr) level<1.5 times the upper limit of normal value, serum alanine transaminase (AST) and glutamic transaminase (ALT) levels<2.5 times the upper limit of normal value, and serum bilirubin level ≤ 1.5 times the upper limit of normal value.
• The patient has signed an informed notice and is willing and able to comply with the visit, treatment plan, laboratory examination, and other research procedures of the research plan.