進行性非淡明細胞腎細胞がんの第一選択治療としてのアンロチニブとシンチリマブの併用

Inclusion Criteria:

• Subjects voluntarily joined the study and signed informed consent;

• Aged > 18 years;

• ECOG body status score is 0 or 1,Expected survival time is greater than 3 months.

• Locally advanced or metastatic, histological confirmed, non-clear cell RCC of all subtypes. Patients must have advanced non-clear cell of one of the following subtypes: papillary, chromophobe, collecting duct carcinoma (CDC), renal medullary carcinoma (RMC), or unclassified.

• Patients must have measurable lesions as defined by the RECIST 1.1 standard;

• Adequate hematologic and end-organ function as defined by the following laboratory results obtained within 28 days prior to the first study treatment:

  1. Absolute neutrophil count (ANC) ≥1.5x 109/L
  2. Lymphocyte count ≥ 500/uL.
  3. Platelet count ≥ 80x109/L.
  4. Hemoglobin ≥ 80 g/L (patients may be transfused to meet this criterion).
  5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) with the following exceptions: Patients with documented liver/bone metastases should have AST and ALT ≤ 5 x ULN.
  6. Serum bilirubin ≤ 1.5 x ULN.
  7. Creatinine clearance ≥ 60 mL/min.
  8. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly effective forms of contraception and to continue its use 4 weeks after the last dose of anlotinib or sintilimab.

• Signed informed consent form.

• Ability and capacity to comply with study and follow-up procedures.

Exclusion Criteria:

• Those who are known to be allergic to pharmaceutical ingredients.
• Receive anti-tumor monoclonal antibody or other research drugs within 4 weeks before enrollment; have received other anti-PD-1 antibody therapy or other treatment for PD-1/PD-L1;
• Previous use of anlotinib or other angiogenesis inhibitors
• The patient has any active autoimmune disease or a history of autoimmune disease;
• There are uncontrolled heart clinical symptoms or diseases;
• Patients with congenital or acquired immune deficiency;
• Receive chemotherapy, targeted therapy, radiotherapy within 2 weeks before enrollment;
• A history of gastrointestinal perforation or major surgery within 4 weeks before enrollment;
• Overactive/venous thrombosis occurred within 6 months prior to enrollment, such as cardiovascular-cerebral vascular (including transient ischemic attack),deep vein thrombosis (except for patients who have recovered from venous catheterization due to previous chemotherapy)and pulmonary embolism;
• Those with active bleeding or bleeding tendency;
• Presence of a drug uncontrolled hypertension;
• Urine routine indicates more than urinary protein 2+;
• Correct QT interval > 470msec; if the patient has a prolonged QT interval, but the investigator's study evaluates that the prolongation is due to a cardiac pacemaker (and no other abnormalities in the heart), it is necessary to discuss with the sponsor's researcher to determine if the patient is Suitable for group study;
• Patients suspected of having other primary cancers;
• Those who are known to be allergic to pharmaceutical ingredients.
• Patients with active or chronic hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening). Patients with past/resolved HBV infection (defined as having negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. A negative HBA DNA test must be obtained in patients with positive hepatitis B core antibody prior to Cycle 1 Day 1.
• Active hepatitis C infection. Patients positive hepatitis C antibody test are eligible if PCR is negative for hepatitis C viral DNA.
• Pregnant or lactating women.