ES-SCLC
Conditions
Interventions
Test group:Chemotherapy combined with serplulimab was accompanied by radiotherapy for liver metastases
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form, with a male or female age of 18 at the time of signing; 2. Be able to comply with the research protocol; 3. ES-SCLC confirmed by histology or cytology (according to the American Veterans Administration Lung Cancer Society [VALG] staging system); 4. Having at least one measurable liver metastasis lesion, with a total number of liver metastases = 3 months; 8. Adequate hematology and terminal organ function, as defined by the following laboratory test results, must be obtained within 14 days prior to the first study treatment: Absolute neutrophil count (ANC) >=1.5×10^9/L (1500/L) (not treated with granulocyte colony-stimulating factor) Platelet count >= 75 × 10^9/L (75000/µ L) (without transfusion) Hemoglobin >= 80g/L (8.0g/dL) Aspartate transaminase (AST) and alanine transaminase (ALT) = 60mL/min (calculated using the Cockcroft Gault formula) Albumin >= 30g/L (2.5g/dL) For patients who have not received anticoagulant therapy: International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (aPTT) <= 1.5 × ULN; 9. For patients receiving anticoagulant therapy: a stable anticoagulant regimen; 10. When screening, the human immunodeficiency virus (HIV) test result was negative; 11. When screening, the result of hepatitis C virus (HCV) antibody detection is negative, or when screening, the result of HCV antibody detection is positive, and the subsequent HCVRNA detection result is negative. Patients who test positive for HCV antibodies must undergo HCV RNA testing; 12. For women with reproductive potential: agree to abstain from sexual intercourse (not engage in heterosexual intercourse) or use contraceptive measures, defined as follows: Maintain abstinence or use contraceptive measures with an annual failure rate of less than 1% during the treatment period and for 6 months after the last use of Slulimumab, as well as for 6 months after the last use of cisplatin/carboplatin or etoposide. Women are prohibited from donating eggs during this period. The following women are considered to have fertility potential: those who have experienced menarche, have not reached postmenopausal status (continuous amenorrhea for = 12 months, and have no other reasons besides menopause), and have not been permanently unable to conceive due to surgery (i.e. removal of ovaries, fallopian tubes, and/or uterus) or other reasons determined by researchers (such as Mullerian tube hypoplasia). Contraceptive methods with an annual failure rate of less than 1% include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone releasing intrauterine devices, and copper containing intrauterine devices. The reliability of abstinence should be evaluated based on the duration of the study, patient preferences, and usual lifestyle. Periodic abstinence (such as calendar calculation, ovulation period method, basal body temperature contraception, post ovulation safe period contraception) and withdrawal are insufficient contraceptive methods. 13. For males: agree to abstain from sexual intercourse (not engage in heterosexual intercourse) or use condoms, and agree to avoid donatin
Exclusion criteria
Exclusion criteria: 1. Mixed small cell lung cancer; 2. Soft meningeal metastasis or brain metastasis still progresses after radiotherapy; 3. Poorly controlled pleural effusion, pericardial effusion, or ascites requiring repeated drainage surgery (once a month or more frequently) Allow patients to use indwelling catheters (such as PleurX) ®); 4. Having pneumonia of grade = 3 or active pneumonia or tuberculosis; 5. Severe cardiovascular disease (such as New York Heart Association Grade II or above heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmia, or unstable angina occurred within the 3 months prior to the start of the study treatment; 6. Malignant tumors other than small cell lung cancer (SCLC) occurred within 2 years prior to the start of the study treatment, except for the investigational cancer and malignant tumors with negligible risk of metastasis or death in the study, such as fully treated cervical carcinoma in situ, non melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer; 7. Serious infections occurred within the 2 weeks prior to the start of treatment, including but not limited to hospitalization due to infection, bacteremia, severe pneumonia, or any active infection that may affect patient safety; 8. Previously received allogeneic stem cell or solid organ transplantation; 9. There are contraindications to the use of research drugs, any other diseases that may affect result interpretation or treatment complications that may pose a high risk to patients, metabolic disorders, physical examination abnormalities, or clinical laboratory abnormalities; 10. Known to cause hypersensitivity reactions to any component of the Slulimumab formulation; 11. Known to have allergic or hypersensitivity reactions to any component of cisplatin/carboplatin or etoposide preparations; 12. Pregnant or lactating women, or women planning to become pregnant during the study treatment period or at least 5 months after the last dose of Slulimumab, or within 6 months after the last dose of cisplatin/carboplatin or etoposide Women with fertility potential must undergo a serum pregnancy test within 14 days prior to the start of study treatment, and the result must be negative;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;PFS rates at 6 months and 1 year;Duration of remission;Overall objective response rate and objective response rate of liver metastases;Median overall survival;security; | — |
Countries
China
Contacts
Public ContactXiangjiao Meng
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed