Grade >=1 RCCEP during treatment with camrelizumab-based therapy
Conditions
Interventions
Observation group:None
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age range: 18 - 75 years old (inclusive of 18 and 75), gender not restricted. 2. Stage IV non-small cell lung cancer confirmed by pathological histology or cytology (according to the eighth edition of the International Union Against Cancer/American Joint Committee on Cancer Cancer Staging System). 3. There is at least one measurable lesion, in accordance with the RECIST 1.1 standard. 4. When receiving treatment based on carilizumab, the first occurrence of >= 1 grade 1 RCCEP was observed. 5. Physical condition score (ECOG PS score): 0 - 1 point. 6. Expected survival period >= 3 months. 7. Negative for EGFR or ALK mutations. 8. No active brain metastasis. 9. The major organs function well, that is, within the 14 days prior to enrollment, the relevant test indicators met the following requirements: hemoglobin >= 90 g/L (no blood transfusion within 14 days); neutrophil count > 1.5×10^9/L; platelet count >= 100×10^9/L; total bilirubin = 60 mL/min (Cockcroft-Gault formula); cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= 50%. 10. Women of childbearing age must undergo a serum pregnancy test 7 days prior to the first administration of the drug, and the result must be negative. Male subjects who are the partners of women of childbearing age and are also women of childbearing age must agree to use an effective method of contraception during the study and for 180 days after the last administration of the study drug. 11. Understand the research procedures and contents, and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1.The subjects diagnosed with other pathological types of non-small cell lung cancer, including those with squamous adenocarcinoma and those with NSCLC containing small cell lung cancer components. 2. Subjects with known EGFR mutations or ALK positive conditions. 3. Subjects who have previously received PD-(L)1 or CTLA-4 therapy other than carfilzomib. 4. The use of anti-angiogenic drugs that have been previously used is not permitted. 5. Treatment other than apatinib for RCCEP is not allowed. 6. Have a hereditary bleeding tendency or coagulation dysfunction. Within 3 months before enrollment, have had clinically significant bleeding symptoms or have a clear bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcers, baseline fecal occult blood ++ or above. The lesion has obvious vascular invasion. 7. Subjects with active central nervous system (CNS) metastases. If the CNS metastases of the subjects can be adequately treated, such as when the clinical stability (detected by MRI) has been maintained for at least 4 weeks, and the neurological symptoms of the subjects can recover to the baseline level (excluding residual signs or symptoms related to CNS treatment) at least 2 weeks before the first administration of the drug, they can participate in the study. Additionally, if the subjects use corticosteroid hormones to treat related clinical symptoms and receive a stable or gradually reduced dose of = 10 mg/day of prednisone (or equivalent) for at least 2 weeks, they can participate in the study; otherwise, they cannot be enrolled. 8. Subjects with active, known or suspected autoimmune diseases. Subjects with stable dose insulin treatment for type 1 diabetes, subjects with hypothyroidism requiring hormone replacement therapy, and subjects without systemic treatment and without acute deterioration of skin diseases (such as eczema, vitiligo or psoriasis) within one year before screening can be included. 9. Those with congenital or acquired immune deficiencies, such as individuals infected with the Human Immunodeficiency Virus (HIV). 10. Have the following poorly controlled infectious diseases: active hepatitis B (with positive HBsAg and HBV DNA >= 2000 IU/ml or 12500 copies/ml) or hepatitis C (with positive hepatitis C antibody and HCV-RNA above the detection limit of the analytical method); active tuberculosis or currently undergoing anti-tuberculosis treatment. 11. There is a previous or current objective evidence of idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation-induced pneumonia, organizing pneumonia (such as bronchitis, obliterative arteritis), drug-induced pneumonia, active pneumonia detected by CT, or severe impairment of lung function; 12. The cardiac function and diseases meet one of the following conditions, which the researchers consider to have clinical significance and are significantly abnormal and unsuitable for inclusion in this study. Arrhythmias include but are not limited to complete left bundle branch block, second-degree atrioventricular block; 12-lead electrocardiogram (ECG) measurement, QTc interval for males>= 450ms, females >= 470ms; New York Heart Association (NYHA) classification >= 3 grade heart dysfunction or echocardiography examination: left ventricular ejection fraction (LVEF) grade 2), such as infect
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RCCEP cure rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| RCCEP level reduction rate;3-week RCCEP cure rate;Safety;3-week RCCEP level reduction rate;6-week RCCEP cure rate;6-week RCCEP level reduction rate;To the median disappearance time of RCCEP;The incidence rate of reverting to a level below RCCEP (= level 2); | — |
Countries
China
Contacts
Public ContactMa Aiping
The First Affiliated Hospital of Xiamen University
Outcome results
None listed