Y-90 With Durvalumab/Gem/Cis in Intrahepatic Cholangio
NCT05655949 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-04-22
Summary
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)
Conditions
- Bile Duct Cancer
- Cholangiocarcinoma
- Cholangiocarcinoma Non-resectable
- Cholangiocarcinoma Metastatic
- Metastatic Intrahepatic Cholangiocarcinoma
Interventions
- DRUG
-
Intravenous infusion
- DRUG
-
Intravenous infusion
- DRUG
-
Intravenous infusion
- RADIATION
-
Yttrium-90
Injection of radiation microsphere beads
Sponsors & Collaborators
-
Sirtex Medical
collaborator INDUSTRY - collaborator OTHER
-
Beth Israel Deaconess Medical Center
lead OTHER
Principal Investigators
-
Andrea Bullock, MD, MPH · Beth Israel Deaconess Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-13
- Primary Completion
- 2026-12-01
- Completion
- 2027-12-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Capecitabine and Y-90 Radioembolization in Treating Patients With Advanced Bile Duct Cancer in the Liver That Cannot Be Removed by Surgery
NCT03117855 ·Status: WITHDRAWN ·Phase: PHASE1
-
Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation
NCT06501625 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Phase IIb Randomized Clinical Trial of Immune Checkpoint Inhibitor-based Maintenance Therapy in Patients With Advanced Biliary Tract Cancer
NCT07269158 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
Gemcitabine-Cisplatin-90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma
NCT02512692 ·Status: TERMINATED ·Phase: NA
-
Nivolumab and Yttrium Y 90 Glass Microspheres in Treating Patients With Advanced Liver Cancer
NCT02837029 ·Status: COMPLETED ·Phase: PHASE1
-
Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic Biliary Tract Cancer
NCT06274879 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Two-Arm, Multicenter, Non-Randomized Controlled Study on the Efficacy of Yttrium-90 (Selective Internal Radiation Therapy) Therapy and Hepatic Arterial Infusion Chemotherapy (Hepatic Artery Infusion Chemotherapy) for Potentially Resectable Intermediate and Advanced Hepatocellular Carcinoma
NCT07070076 ·Status: RECRUITING ·Phase: NA
-
Nivolumab and Yttrium-90 in Treating Patients With Liver Cancer Undergoing Surgical Resection
NCT03812562 ·Status: TERMINATED ·Phase: EARLY_PHASE1
-
Durvalumab and Tremelimumab in Combination With Y-90 SIRT for Intermediate Stage HCC
NCT04522544 ·Status: RECRUITING ·Phase: PHASE2
-
Efficacy and Safety of Yttrium-90 Microspheres Selective Internal Radiotherapy Combined with Immune Checkpoint Inhibitors and Anti-angiogenesis Drugs Sequential HAIC for Hepatocellular Carcinoma
NCT06867432 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Study of Tumor-Treating Fields in Combination With Durvalumab and Gemcitabine/Cisplatin in Biliary Tract Cancers
NCT06611345 ·Status: RECRUITING ·Phase: NA
-
Durvalumab and Lenvatinib With or Without Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer
NCT05935579 ·Status: RECRUITING ·Phase: PHASE2
-
Durvalumab + Intraductal Radiofrequency Ablation (ID-RFA) in Extrahepatic Cholangiocarcinoma
NCT06440993 ·Status: RECRUITING ·Phase: PHASE2
-
Selective Internal Radiation Therapy and Capecitabine (Chemotherapy) Treatment for Liver Cancer
NCT05265208 ·Status: RECRUITING ·Phase: PHASE2
-
Sintilimab Plus Bevacizumab and SIRT for Intermediate-advanced HCC
NCT06397222 ·Status: RECRUITING ·Phase: PHASE2
-
Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer
NCT05065957 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Safety and Pharmacokinetics of Treating Liver Cancer With Drug-Eluting Beads
NCT01336985 ·Status: TERMINATED ·Phase: PHASE1
-
Yttrium-90 Carbon Microspheres in Patients With Unresectable Hepatocellular Carcinoma
NCT05957640 ·Status: UNKNOWN ·Phase: PHASE1
-
Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients
NCT04736121 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
A Trial of Systemic Chemotherapy in Combination With Conventional Transarterial Chemoembolization in Patients With Advanced Intra-Hepatic Cholangiocarcinoma
NCT02994251 ·Status: TERMINATED ·Phase: PHASE2
-
A Pilot Study of Combined Immune Checkpoint Inhibition in Combination With Ablative Therapies in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC)
NCT02821754 ·Status: COMPLETED ·Phase: PHASE2
-
Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)
NCT05953337 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Sorafenib Therapy Prior to Radiofrequency Ablation for Intermediate Sized Hepatocellular Cancer
NCT00813293 ·Status: COMPLETED ·Phase: PHASE2
-
SIRT With Tremelimumab and Durvalumab for Resectable HCC
NCT05701488 ·Status: RECRUITING ·Phase: PHASE1
-
Study of SIR-Spheres Plus Sorafenib as 1st Line Treatment for Non-resectable Primary Hepatocellular Carcinoma (HCC)
NCT00712790 ·Status: COMPLETED ·Phase: PHASE1/PHASE2