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NCT06058663 · ClinicalTrials.gov registry record · Phase 1
Radioembolization With Tremelimumab and Durvalumab for Locally Advanced Unresectable or Oligo-Metastatic Intrahepatic Cholangiocarcinoma
A Phase 1 study of Stage III Intrahepatic Cholangiocarcinoma AJCC v8 and Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT06058663 is a Phase 1 study of Stage III Intrahepatic Cholangiocarcinoma AJCC v8 and Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 16 participants, below the 41-participant average among 8 other Stage III Intrahepatic Cholangiocarcinoma AJCC v8 trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06058663, a Phase 1 study of Stage III Intrahepatic Cholangiocarcinoma AJCC v8 and Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy
- BIOLOGICAL Durvalumab
- PROCEDURE Angiography
Study Locations (1)
Florida
- Mayo Clinic in Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2024-06-06 |
| Est. Completion | 2028-11-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06058663
The ClinicalTrials.gov registry entry for NCT06058663 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 41-participant average among 8 other Stage III Intrahepatic Cholangiocarcinoma AJCC v8 trials with a reported enrollment target (61% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Stage III Intrahepatic Cholangiocarcinoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06058663 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT06058663 about?
NCT06058663 is a clinical study titled "Radioembolization With Tremelimumab and Durvalumab for Locally Advanced Unresectable or Oligo-Metastatic Intrahepatic Cholangiocarcinoma". 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 (...
What is the current status of trial NCT06058663?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2024-06-06. Estimated completion is 2028-11-30.
What conditions does trial NCT06058663 study?
This clinical trial studies the following conditions: Stage III Intrahepatic Cholangiocarcinoma AJCC v8, Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, Unresectable Intrahepatic Cholangiocarcinoma, Locally Advanced Intrahepatic Cholangiocarcinoma, Oligometastatic Intrahepatic Cholangiocarcinoma.
What interventions are being tested in trial NCT06058663?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Durvalumab (BIOLOGICAL), Angiography (PROCEDURE).
Who is sponsoring clinical trial NCT06058663?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06058663 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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