Malignant pleural effusion
Conditions
Interventions
treatment group:JMKX000197 monotherapy
Sponsors
Zhongnan Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily joined the study, signed an informed consent form, and had good compliance. 2. Age >= 18 years and = 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) = 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= 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.
Exclusion criteria
Exclusion criteria: 1. Known allergies to the study drug or its excipient components. 2. The location of pleural effusion is not suitable for drainage or the patient will not benefit from intrathoracic medication (e.g., severe separation). 3. Have used interferon gene stimulating factor (STING) agonists, TNF drugs (such as Tianenfu) for thoracic injection. 4. Have participated in other clinial trials within 4 weeks before signing the informed consent form. 5. Have a history of immunodeficiency, including a positive test for human immunodeficiency virus (HIV) antibodies, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation. 6. Uncontrollable systemic infections (viruses, bacteria, fungi), including but not limited to hepatitis B surface antigen positive and hepatitis B virus DNA > 1000 IU/ml, hepatitis C virus (HCV) antibody positive or RNA positive. 7. According to the judgment of the researcher, the patient is not suitable for participating in this clinical study for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose limiting toxicity;Maximum tolerated dose;Recommended Phase II dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate(ORR);Disease control rate, DCR;Pharmacokinetic parameters;Evaluation parameters of drug metabolism and transformation;Expression levels of related cytokines in plasma and pleural fluid; | — |
Countries
China
Contacts
Public ContactHuang Jianying
Zhongnan Hospital of Wuhan University
Outcome results
None listed