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Checkpoint Inhibitor

Radioembolization + Immunotherapy for Bile Duct Cancer

Q: Are there any unfilled slots remaining for participants in this medical trial?

According to clinicaltrials.gov, enrollment in this investigation has been concluded and it is no longer recruiting subjects. It was first posted on October 1st 2023 with its last update published on September 22nd 2023. However, there are presently 208 other trials that are accepting participants.

Q: Has the combination of Y90, tremelimumab on day 1, cycle 1 and durvalumab been regulatory approved by the FDA?

Our team has given Cohort I: (Y90, tremelimumab on day 1, cycle 1, durvalumab) a score of 1 due to its status as a Phase 1 trial. This means that there is minimal data regarding both safety and efficacy.

Q: What is the primary intent of this research project?

As the primary outcome, this study will monitor the incidence of treatment-emergent adverse events (safety and tolerability) across a 28 day period. Secondary objectives involve an exploration into median progression free survival, median overall survival as well as objective response rates evaluated through modified RECIST version 1.1, mRECIST and PERCIST criteria for each patient. Responses will be summarized according to simple descriptive summary statistics detailing complete and partial responses in addition to stable or progressive disease among <a href="https://www.withpower.com/clinical-trials/all">all</a> patients enrolled in the trial.

Phase 1

Waitlist Available

Led By Umair Majeed, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 18 years with body weight > 30 kg

Histologically or cytologically confirmed, locally advanced intrahepatic cholangiocarcinoma that is not amenable to resection, transplantation, or thermal ablation. Oligometastatic intrahepatic cholangiocarcinoma is also eligible. Specifically, such patients must have EITHER =< 3 malignant extrahepatic lymph nodes (short axis diameter >= 3cm) OR metastatic lesions in one organ other than liver (if only single lesion is present diameter MUST be < 3cm, if up to 3 lesions in one organ each lesion MUST be =< 1cm)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial tests if combining Y90 radioembolization with immunotherapy can help treat advanced, unresectable intrahepatic cholangiocarcinoma, a rare and aggressive cancer with few curative options.

Who is the study for?

This trial is for adults over 18 with locally advanced, unresectable intrahepatic cholangiocarcinoma who can't have curative therapy. They should be in good physical condition (ECOG PS 0 or 1), not pregnant, and without severe concurrent diseases or a history of multiple treatments for this cancer.Check my eligibility

What is being tested?

The trial tests Y90 radioembolization combined with two monoclonal antibodies, tremelimumab and durvalumab. It aims to see if this combination is safe and effective at killing more tumor cells in patients who cannot undergo surgery.See study design

What are the potential side effects?

Potential side effects include typical reactions to immunotherapy like fatigue, skin reactions, inflammation of organs as well as those related to radiation such as localized pain or damage to surrounding tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old and weigh more than 30 kg.

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My bile duct cancer cannot be surgically removed and may have spread, but only a little.

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My liver is functioning well, with a Child-Pugh score A and ALBI grade 1 or 2.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer can be measured by tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) (Cohort 1)

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) (Cohort 2)

Secondary outcome measures

Change in absolute monocyte count (AMC)

Change in absolute neutrophil count (ANC)

Change in absolute neutrophil count to absolute lymphocyte count (ANC:ALC) ratio

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort II: (Y90, tremelimumab on day 14, cycle 1, durvalumab )Experimental Treatment9 Interventions

Patients receive transarterial Y90 radioembolization on day 1 of cycle 1 and receive tremelimumab IV over 1 hour on day 14 of cycle 1 and durvalumab IV over 1 hour on day 14 of each cycle. Cycles repeat every 42 days for cycle 1 and then every 28 days for cycles 2-24 in the absence of disease progression or unacceptable toxicity. Patients also undergo mapping angiography during screening, as well as CT and MRI or PET/CT during screening and on study. Patients also undergo blood sample collection throughout the trial and may undergo tumor biopsy during screening and on study.

Group II: Cohort I: (Y90, tremelimumab on day 1, cycle 1, durvalumab)Experimental Treatment9 Interventions

Patients receive transarterial Y90 radioembolization and tremelimumab IV over 1 hour on day 1 of cycle 1 and durvalumab IV over 1 hour on day 1 of each cycle. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo mapping angiography during screening as well as CT and MRI or PET/CT during screening and on study. Patients also undergo blood sample collection throughout the trial and may undergo tumor biopsy during screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Angiography

2014

N/A

~1900

Biospecimen Collection

2004

Completed Phase 2

~1730

Computed Tomography

2017

Completed Phase 2

~2720

Biopsy

2014

Completed Phase 4

~850

Durvalumab

2017

Completed Phase 2

~3870

Positron Emission Tomography

2008

Completed Phase 2

~2240

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Tremelimumab

2017

Completed Phase 2

~3380

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,206 Previous Clinical Trials

3,767,067 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,651 Total Patients Enrolled

4 Trials studying Intrahepatic Cholangiocarcinoma

1,157 Patients Enrolled for Intrahepatic Cholangiocarcinoma

Umair Majeed, M.D.Principal InvestigatorMayo Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled slots remaining for participants in this medical trial?

"According to clinicaltrials.gov, enrollment in this investigation has been concluded and it is no longer recruiting subjects. It was first posted on October 1st 2023 with its last update published on September 22nd 2023. However, there are presently 208 other trials that are accepting participants."

Answered by AI

Has the combination of Y90, tremelimumab on day 1, cycle 1 and durvalumab been regulatory approved by the FDA?

"Our team has given Cohort I: (Y90, tremelimumab on day 1, cycle 1, durvalumab) a score of 1 due to its status as a Phase 1 trial. This means that there is minimal data regarding both safety and efficacy."

Answered by AI

What is the primary intent of this research project?

"As the primary outcome, this study will monitor the incidence of treatment-emergent adverse events (safety and tolerability) across a 28 day period. Secondary objectives involve an exploration into median progression free survival, median overall survival as well as objective response rates evaluated through modified RECIST version 1.1, mRECIST and PERCIST criteria for each patient. Responses will be summarized according to simple descriptive summary statistics detailing complete and partial responses in addition to stable or progressive disease among all patients enrolled in the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Radioembolization With Tremelimumab and Durvalumab for Locally Advanced Unresectable or Oligo-Metastatic Intrahepatic Cholangiocarcinoma

2024. "Radioembolization With Tremelimumab and Durvalumab for Locally Advanced Unresectable or Oligo-Metastatic Intrahepatic Cholangiocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06058663.

All > Intrahepatic Cholangiocarcinoma > Cholangiocarcinoma