OncoMatch/Clinical Trials/NCT05655949
Y-90 With Durvalumab/Gem/Cis in Intrahepatic Cholangio
Is NCT05655949 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Chemotherapy
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05655949 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages