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OncoMatch/Clinical Trials/NCT06211114

Study to Evaluate the Efficacy and Safety of Immunotherapy With Axitinib in Advanced Collecting Duct Carcinoma

Is NCT06211114 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including PD-(L)1 inhibitor and Axitinib for collecting duct carcinoma.

Phase 2RecruitingPeking University Cancer Hospital & InstituteNCT06211114Data as of May 2026

Treatment: PD-(L)1 inhibitor · AxitinibThis 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.

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Extracted eligibility criteria

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: systemic therapy — after metastasis

Have received prior systemic therapy after previous metastasis for collecting duct carcinoma

Cannot have received: anti-PD-1 therapy

Prior Anti-PD-1

Cannot have received: anti-PD-L1 therapy

Prior PD-L1

Cannot have received: VEGFR inhibitor (axitinib)

Prior axitinib

Lab requirements

Blood counts

ANC ≥ 1.5×10^9/L. Platelets ≥ 100×10^9/L. Hemoglobin ≥ 9.0g/dL or ≥ 5.6mmol/L.

Kidney function

Serum creatinine ≤ 1.5×ULN

Liver 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.

Cardiac function

Left ventricular ejection fraction (LVEF) ≥ 50%

Adequate function of vital organs: 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. Renal function: Serum creatinine ≤ 1.5×ULN. 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. Endocrine function: Normal thyroid stimulating hormone, or abnormal TSH whilst normal FT3 and FT4. Coagulation function: INR or PT ≤1.5×ULN, and 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. Left ventricular ejection fraction (LVEF) ≥ 50%.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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