OncoMatch/Clinical Trials/NCT06058663
Radioembolization With Tremelimumab and Durvalumab for Locally Advanced Unresectable or Oligo-Metastatic Intrahepatic Cholangiocarcinoma
Is NCT06058663 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Durvalumab and Tremelimumab for locally advanced intrahepatic cholangiocarcinoma.
Treatment: Durvalumab · Tremelimumab — This phase I trial tests the safety and side effects of yttrium-90 (Y90) radioembolization combined with immunotherapy drugs tremelimumab and durvalumab in treating patients with intrahepatic cholangiocarcinoma (cancer of the bile ducts in the liver) that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable) who are not candidates for curative therapy or that has spread from where it first started (primary side) to multiple other places in the body (oligo-metastatic). Cholangiocarcinoma is a rare but aggressive cancer with limited curative options outside of surgery. Immunotherapy has shown modest benefit in hepatobiliary (liver, bile ducts, and gallbladder) cancers including cholangiocarcinoma. Radioembolization is a type of radiation therapy used to treat liver cancer that is advanced or has come back where tiny beads that hold the radioactive substance (radioisotope) yttrium Y90 are injected into or near the hepatic artery (the main blood vessel that carries blood to the liver). The beads collect in the tumor and the Y90 gives off radiation. This destroys the blood vessels that the tumor needs to grow and kills the tumor cells. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving Y90 radioembolization in combination with tremelimumab and durvalumab immunotherapy may be safe and beneficial in treating patients with locally advanced, unresectable or oligo-metastatic intrahepatic cholangiocarcinoma who are not candidates for curative therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Exception: adjuvant setting allowed unless progression during or ≤ 6 months from completion
History of > 1 prior systemic therapy for cholangiocarcinoma not including that in the adjuvant setting. Patients who progressed during or ≤ 6 months from completion of adjuvant therapy are excluded
Cannot have received: locoregional therapy
History of previous locoregional therapy
Cannot have received: therapeutic cancer vaccine
Previous use of therapeutic cancer vaccines
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1000/mm^3; Platelet count ≥ 75,000/mm^3
Kidney function
Calculated creatinine clearance ≥ 40 ml/min using the Cockcroft-Gault formula or measured creatinine clearance > 40 ml/min
Liver function
Total bilirubin ≤ 1.5 x ULN (patients with known Gilbert disease who have serum bilirubin level 3 x ULN may be enrolled); ALT and AST ≤ 5 x ULN; Adequate hepatic function Child Pugh A and albumin-bilirubin (ALBI) 1 or 2
Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1000/mm^3; Platelet count ≥ 75,000/mm^3; Total bilirubin ≤ 1.5 x ULN (patients with known Gilbert disease who have serum bilirubin level 3 x ULN may be enrolled); ALT and AST ≤ 5 x ULN; Calculated creatinine clearance ≥ 40 ml/min using the Cockcroft-Gault formula or measured creatinine clearance > 40 ml/min; Adequate hepatic function Child Pugh A and albumin-bilirubin (ALBI) 1 or 2
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Florida · Jacksonville, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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 qualify