A Phase I Study of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion

Inclusion Criteria

• •1. The patient voluntarily joined the study, signed an informed consent form, and had good compliance.
• •2. Age ≥ 18 years and ≤ 75 years old, regardless of gender.
• •3. Malignant pleural effusion confirmed by histopathology or cytopathology as moderate or above and requiring drainage (definition of moderate pleural effusion: pleural effusion ≥ 3cm in lying position by B-ultrasound, pleural effusion ≥ 4cm in sitting position by B-ultrasound, accompanied by clinical symptoms such as chest tightness, shortness of breath, and discomfort).
• •4. Karnofsky score ≥ 60, or physical fitness score (ECOG PS) ≤ 2.
• •5. Expected survival time ≥ 3 months.
• •6. Within 7 days before treatment, the main organ function meets the following criteria: blood routine examination criteria (without blood transfusion within 14 days): neutrophil count ≥ 1.5 × 10 \^ 9 /L, Hemoglobin ≥ 9g/dL, Platelets ≥ 100 × 10 \^ 9 /L, White blood cells ≥ 3.0 × 10 \^ 9 /L; Biochemical examination indicators should meet: total bilirubin ≤ 1.5 × ULN, ALT≤2.5 × ULT, AST≤2.5 × ULT, if accompanied by liver metastasis, ALT and AST ≤ 5 × ULN, Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate (CCr) ≥ 60ml/min; International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN.
• •7. No intrathoracic drug injection was performed within 1 month before signing the informed consent form, but diagnostic puncture is not excluded.
• •8. Women of reproductive age should agree to use contraception (such as intrauterine devices, birth control pills, or condoms) during the study period and within 6 months after the end of the study; The serum pregnancy test was negative within 7 days before enrollment and must be a non lactating patient; Men should agree to use effective contraception during the study period and within 6 months after the end of the study period.