Study to Evaluate the Efficacy and Safety of Immune Checkpoint Inhibitors in Combination With Axitinib in Previously Treated Advanced Collecting Duct Carcinoma
This is a phase II trial to evaluate the efficacy and safety of immune checkpoint inhibitors in combination with axitinib for previously treated advanced collecting duct carcinoma.
• Fully understand and be willing to provide written informed consent.
• Male or female with age ≥ 18 years and \<80 years.
• Have received prior systemic therapy after previous metastasis for collecting duct carcinoma, histologically confirmed diagnosis of unresectable, recurrent or metastatic collecting duct carcinoma.
• Having at least one measurable disease per RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if re-progression has been demonstrated.
• ECOG PS 0 or 1.
• Adequate function of vital organs:
⁃ 1 Bone marrow function (without blood or blood products transfusion, without hematopoietic stimulating factor or other medication to improve blood cell count within 2 days prior to first dose of study drug): Absolute neutrophil count (ANC) ≥ 1.5×109/L. Platelets ≥ 100×109/L. Hemoglobin ≥ 9.0g/dL or ≥ 5.6mmol/L. 6.2 Renal function: Serum creatinine ≤ 1.5×ULN 6.3 Hepatic function:Serum total bilirubin ≤1.5×ULN or total bilirubin levels \>1.5×ULN with direct bilirubin ≤ ULN. AST and ALT ≤2.5 × ULN, ≤5×ULN in those with hepatic metastasis.
⁃ 4 Endocrine function: Normal thyroid stimulating hormone, or abnormal TSH whilst normal FT3 and FT4.
⁃ 5 Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN, and activated partial thromboplastin time (aPTT) ≤1.5×ULN, Subjects receiving anticoagulant therapy (e.g., heparin or warfarin) may participate in the study with PT or APTT levels within the scope of the proposed therapy and monitored during study treatment.
⁃ 6 Left ventricular ejection fraction (LVEF) ≥ 50%.
• Being willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
• Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first treatment dose. Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must agree to use a highly effective methods of contraceptive throughout the study and for 180 days after the last dose of study therapy.