Patients with advanced melanoma after immunotherapy
Conditions
Interventions
Experimental group:Atezolizumab: administered by intravenous infusion, 20mg/kg, on Day 1 of each cycle, repeated every 3 weeks, until disease progression or unacceptable toxicity. Apatinib: administer
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 18 years and above, gender not limited; 2. Confirmed by histopathology as a patient with malignant melanoma of skin/limb/mucosal type; 3. Evaluated as advanced stage (stage III/IV) and previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, or other immune checkpoint inhibitors; BRAF positive patients who have previously failed standard treatment. 4. It is allowed to have undergone radical surgical resection in the past, received adjuvant or neoadjuvant therapy, but it is required to be completed at least 4 weeks before the first use of the study drug, and all related toxic events have recovered to normal or CTCAE 5.0 grade I or below, except for hair loss; 5. ECOG score is 0 or 1; 6. Expected survival period>=12 weeks; According to RECIST 1.1 criteria, there must be at least one measurable lesion that has not been irradiated; 8. Patients may have a history of brain/meningeal metastases, but must be assessed as asymptomatic before the start of the study or have a stable condition for at least 3 months after treatment (corticosteroids are allowed to be used before the first dose of the study drug, and the steroid dose needs to be reduced to 10 mg/day of prednisone; or other steroid drugs equivalent to this dose); 9. The organ function levels must meet the following requirements (referring to the monitoring results within 7 days before the first dose of the study drug): Bone Marrow: Absolute Neutrophil Count (ANC) >= 1.5 × 10^9/L, Platelet Count (PLT) >= 80 × 10^9/L, Hemoglobin (HB) >= 9 g/dL (no blood transfusion or component therapy within 14 days prior to testing); Liver: Serum Total Bilirubin (TBIL) = 50 mL/min (Cockcroft-Gault formula); International Normalized Ratio (INR), Activated Partial Thromboplastin Time (aPTT) 2, a 24-hour urine protein collection is required, with a total amount <= 1 gram; Cardiac function must be normal, meaning that ECG examination should be normal or abnormal without clinical significance, and echocardiogram should show Left Ventricular Ejection Fraction (LVEF) greater than 50%. 10. The serum pregnancy test results of women of childbearing age must be negative within 7 days prior to the first administration of the trial drug; men of reproductive capacity or women who may become pregnant must use highly effective contraceptive methods throughout the trial (such as oral contraceptives, intrauterine devices, abstinence, or barrier contraception combined with spermicides), and continue contraceptive measures for 180 days after the treatment ends; 11. Study participants voluntarily join the study, sign an informed consent form, have good compliance, and cooperate with follow-ups.
Exclusion criteria
Exclusion criteria: 1.Patients who are currently participating in other clinical trials of anti-tumor treatment; 2. Patients who are currently undergoing anti-tumor treatment; 3. Patients who have participated in or are currently participating in clinical trials of other drugs/therapies within 4 weeks prior to the first use of the study drug; 4. Major surgical operations were performed or received within 4 weeks before the first administration of the study drug, or recovery from the side effects of this operation has not yet been achieved, live vaccination, immunotherapy, or radiotherapy was conducted within 2 weeks before the first administration of the study drug; 5. The patient has any active autoimmune diseases or a history of autoimmune diseases (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism; Vitiligo that does not require systemic treatment can be included. Asthma that has been completely relieved in childhood and does not require any intervention in adulthood can be included. Asthma patients who require bronchodilators for medical intervention cannot be included. 6. The patient is using immunosuppressants or systemic hormone therapy to achieve immunosuppressive purposes (dosage > 10mg/ day of prednisone or other therapeutic hormones, and continued use within 2 weeks before enrollment; 7. The patient has a history of other malignant tumors except melanoma within the past 5 years, except for cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, early prostate cancer and cervical carcinoma in situ. 8. Those with positive test results for HIV-related antibodies or Treponema pallidum antibodies; 9. Patients with active viral hepatitis who have not received regular antiviral treatment and whose test results show that the virus is in the replication stage; 10. Those who are known to be allergic to the three drugs in this study and any excipients they contain; 11. A large amount of pleural effusion or ascites accompanied by clinical symptoms and requiring symptomatic treatment; 12. Have hypertension that cannot be well controlled after antihypertensive drug treatment (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg); 13. Those with active lung diseases (including but not limited to interstitial pneumonia, pneumonia, obstructive pulmonary disease, asthma) or active pulmonary tuberculosis; 14. Have any uncontrollable clinical problems, including but not limited to: ? Persistent or active (severe) infection; Poorly controlled diabetes; The following conditions occurred within 6 months before the first medication: Pulmonary embolism; Youdaoplaceholder0 Myocardial infarction; Youdaoplaceholder0 Severe or unstable arrhythmia or angina pectoris; Youdaoplaceholder0 Percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; Cerebrovascular accident, transient ischemic attack, cerebral embolism; 15. The patient has any circumstances that affect the subjects' swallowing of the drug; And any circumstances that affect the absorption, distribution, metabolism or excretion process of the test drug in the body; 16. The patient had received hematopoietic stimulating factors within one week before the first administration of the study drug, such as receiving treatments like granulocyte colony-stimulating factor (G-CSF) and erythropoietin; 17. Abnormal coagu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival,PFS;12-month OS rate;6-month Progression-free survival rate;Overall survival,OS;Safety;Disease Control Rate,DCR;Duration of Response,DoR; | — |
Countries
China
Contacts
Public ContactFang Meiyu
Zhejiang Cancer Hospital
Outcome results
None listed