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Alkylating agents

Chemotherapy + Y-90 for Bile Duct Cancer

Phase 2

Recruiting

Led By Arthur A. Winer, MD

Research Sponsored by Inova Health Care Services

Eligibility Criteria Checklist

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

Must have

Noncirrhotic liver - patients should not have a preexisting diagnosis of cirrhosis either diagnosed via biopsy or with features consistent with cirrhosis on imaging (e.g. shrunken liver with nodularity consistent with cirrhosis). Child-Pugh score must be less than 5

Unresectable disease, as deemed by the Inova multidisciplinary tumor board (i.e. disease that cannot be safely resected with negative margins, leaving 2 adjacent segments of liver with intact portal venous and hepatic arterial inflow and intact biliary and hepatic venous outflow with the future liver remnant of sufficient volume to avoid postoperative liver insufficiency)

Must not have

More than 75% hepatic tumor burden

Inability to protect non-target arteries to intestines or solid organs from radioembolization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if adding Yittrium-90 to gemcitabine, cisplatin and nab-paclitaxel chemotherapy will be more effective in shrinking the tumor and controlling cancer.

Who is the study for?

This trial is for adults with intrahepatic cholangiocarcinoma (a type of bile duct cancer) that can't be removed by surgery. Participants must be at least 18, have a tumor at least 2 cm big, no cirrhosis or severe liver issues, and an ECOG score of 0-1 indicating they are fully active or restricted in physically strenuous activity but ambulatory. They should not have had previous chemotherapy for this cancer except certain adjuvant therapy.

What is being tested?

The study tests if combining gemcitabine, cisplatin and nab-paclitaxel (chemotherapy drugs) with Yittrium-90 (Y-90), a direct tumor therapy, is more effective in shrinking tumors and controlling cancer than previous treatments. It involves initial 'induction' chemotherapy followed by Y-90 treatment then 'consolidation' therapy.

What are the potential side effects?

Potential side effects include reactions to the infusion of drugs like fever or chills; low blood counts leading to increased infection risk; fatigue; liver problems due to Y-90; nausea and vomiting from chemotherapy; nerve damage causing numbness or tingling.

Eligibility Criteria

Inclusion Criteria

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

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My liver is healthy and I don't have cirrhosis.

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My cancer cannot be surgically removed without risking liver function.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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Over 75% of my liver is affected by cancer.

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My treatment cannot shield certain arteries leading to my organs.

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My cancer has spread outside the liver but only to areas that can be surgically removed.

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I cannot take nab-paclitaxel, gemcitabine, or cisplatin due to health reasons.

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I have difficulty making decisions due to cognitive issues.

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I have gallbladder cancer.

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My cancer is located in the bile ducts outside the liver or near the liver hilum.

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I have a blood clot in the main vein of my liver or its first branches.

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I have pancreatic or ampullary cancer.

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My tests show I can't safely receive certain liver cancer treatments due to risks found in my blood vessels.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Advance Directives

Secondary study objectives

Assessing Progression Free Survival (PFS)

Disease Control Rate (DCR)

Hepatic Progression-Free Survival (HPFS)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: gemcitabine, cisplatin and Durvalumab chemotherapy with Yittrium-90Experimental Treatment3 Interventions

single arm - Induction Gemcitabine, Cisplatin and Durvalumab Triplet Chemotherapy followed by Gemcitabine, Cisplatin in combination with yttrium-90 (Y-90) Radioembolization

0 / 14Eligibility criteria met