OncoMatch/Clinical Trials/NCT05655949
Y-90 With Durvalumab/Gem/Cis in Intrahepatic Cholangio
Is NCT05655949 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Gemcitabine and Cisplatin for bile duct cancer.
Treatment: Gemcitabine · Cisplatin · Durvalumab — This trial is designed to study a combination of interventions (chemotherapy, immunotherapy, and radiation) as a potential new treatment for bile duct cancer that cannot be removed with surgery. The specific names of the interventions that will be used are: * Y-90 (a type of radiation microsphere bead) * Durvalumab (a type of immunotherapy) * Gemcitabine (a type of chemotherapy) * Cisplatin (a type of chemotherapy)
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic chemotherapy
Exception: Prior surgical resection and adjuvant chemotherapy or chemoradiotherapy is allowed if more than 6 months have elapsed since last dose of treatment, and if the tumor is amenable to Y-90 SIRT
Received prior systemic chemotherapy and/or radiotherapy for intrahepatic cholangiocarcinoma
Cannot have received: radiotherapy
Exception: Prior surgical resection and adjuvant chemotherapy or chemoradiotherapy is allowed if more than 6 months have elapsed since last dose of treatment, and if the tumor is amenable to Y-90 SIRT
Received prior systemic chemotherapy and/or radiotherapy for intrahepatic cholangiocarcinoma
Cannot have received: anti-PD-1 therapy (durvalumab)
Prior treatment with anti-PD-1, anti-PD-L, including durvalumab antibody, or any other drug treatment specifically targeting T-cell co-stimulation or checkpoint pathways
Lab requirements
Blood counts
Hemoglobin ≥9.0 g/dL; ANC ≥1.0 × 10^9 /L; Platelet count ≥75 × 10^9/L
Kidney function
Serum creatinine ≤ 1.5 mg/dL OR measured or calculated creatinine clearance >40 mL/min
Liver function
Bilirubin ≤1.5 x ULN; ALT ≤ 2.5 x ULN unless liver metastases are present, in which case ≤5x ULN; AST ≤ 2.5 x ULN unless liver metastases are present, in which case ≤5x ULN; Gilbert's syndrome exception allowed with physician consultation
Participants must have adequate marrow function as defined below: Hemoglobin ≥9.0 g/dL, ANC ≥1.0 × 10^9 /L, Platelet count ≥75 × 10^9/L; adequate renal function: Serum creatinine ≤ 1.5 mg/dL OR measured or calculated creatinine clearance >40 mL/min; adequate hepatic function: Bilirubin ≤1.5 x ULN, ALT ≤ 2.5 x ULN unless liver metastases are present, in which case ≤5x ULN, AST ≤ 2.5 x ULN unless liver metastases are present, in which case ≤5x ULN; Gilbert's syndrome exception allowed
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Beth Israel Deaconess Medical Center · Boston, Massachusetts
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