| Eligibility |
Inclusion Criteria:
- Age = 18 years old, regardless of gender.
- Histology and pathology confirmed advanced mucosal melanoma.
- Gene mutation state is not limited, except BRAFV600 mutation.
- Has not received first-line treatment for advanced melanoma, and temozolomide and
cisplatin have been used in the adjuvant therapy phase, except that the adjuvant
therapy phase has been over 6 months or more.
- Eastern Cancer Cooperation Group (ECOG) physical condition score (PS) 0-1.
- The estimated survival time is more than 3 months.
- Within 7 days before screening (including 7 days), the laboratory data were required
as follows: neutrophil count = 1.5 × 109 shock L, platelet count = 90 × 109 shock L,
hemoglobin = 90g/L (no blood transfusion within 14 days), serum total bilirubin =
1.25x normal upper limit (ULN), ALT and AST = 2.5xULN (patients with liver metastasis
= 5xULN); serum creatinine = 1.25xULN.
- Have at least one measurable focus (RECIST1.1 standard).
- Subjects (or their legal representatives / guardians) must sign an informed consent
form indicating that they understand the purpose of the study, understand the
necessary procedures for the study, and are willing to participate in the study.
Exclusion Criteria:
- Patients who have previously used PD-L1 inhibitors, except those who progressed 1 year
after the end of adjuvant therapy of PD-L1 monoclonal antibody;
- Allergic to Envafolimab or recombinant human endostatin and experimental
chemotherapeutic drugs;
- Received any experimental drugs or antineoplastic drugs within 4 weeks before entering
the group;
- There is a risk of bleeding, bleeding events of clinical significance or other taboos
in the use of antivascular drugs;
- There is a history of other tumors in the past five years, except for cured cervical
cancer or skin basal cell carcinoma;
- There are tumor emergencies that require immediate radiotherapy, such as symptomatic
brain or meningeal metastasis, bone-related events, etc;
- Pregnant or lactating women; Fertile women who do not use adequate contraception;
- Alcohol or drug addiction;
- Patients with active, or history of autoimmune diseases that may recur (e.g. systemic
lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune
thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or
patients at high risk (such as immunosuppressive therapy required for organ
transplants). Except for autoimmune hypothyroidism that requires only hormone
replacement therapy or skin diseases that do not require systemic treatment;
- Patients who need to receive systemic corticosteroids (dose equivalent to > 10mg
prednisone / day) or other immunosuppressive drugs within 14 days before enrollment or
during the study. The use of topical or inhaled corticosteroids, or short-term (= 7
days) use of glucocorticoids for the prevention or treatment of non-autoimmune and
infrequent allergic diseases;
- Important organ failure or other serious diseases, including interstitial pneumonia,
clinically related coronary artery disease, cardiovascular disease or myocardial
infarction, congestive heart failure, unstable angina pectoris, symptomatic
pericardial effusion or unstable arrhythmia within 6 months before admission;
- A history of human immunodeficiency virus infection, or other acquired, congenital
immunodeficiency diseases, or a history of organ transplant or stem cell
transplantation;
- Patients with active chronic hepatitis B or active hepatitis C. HBV carriers, stable
hepatitis B (DNA titer = 103copies / ml) and cured hepatitis C patients (HCVRNA
negative) can be enrolled in the group;
- A history of severe neurological or psychiatric illness; severe infection; active
disseminated intravascular coagulation or other concomitant diseases that, in the
opinion of the researchers, seriously endanger the safety of patients or affect the
completion of the study.
|
