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Alkylating agents
Chemotherapy + Y-90 for Bile Duct Cancer
Phase 2
Waitlist Available
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Advance Directives
Secondary outcome measures
Assessing Progression Free Survival (PFS)
Disease Control Rate (DCR)
Hepatic Progression-Free Survival (HPFS)
+5 moreTrial 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
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Who is running the clinical trial?
Inova Health Care ServicesLead Sponsor
69 Previous Clinical Trials
22,243 Total Patients Enrolled
Arthur A. Winer, MDPrincipal InvestigatorInova Schar Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Over 75% of my liver is affected by cancer.My tests show I can't safely receive certain liver cancer treatments due to risks found in my blood vessels.My bile duct cancer is confirmed and either untreated or was last treated over 6 months ago.My treatment cannot shield certain arteries leading to my organs.My cancer has spread outside the liver but only to areas that can be surgically removed.I cannot take nab-paclitaxel, gemcitabine, or cisplatin due to health reasons.I have difficulty making decisions due to cognitive issues.I have gallbladder cancer.My cancer is located in the bile ducts outside the liver or near the liver hilum.I have a blood clot in the main vein of my liver or its first branches.My liver is healthy and I don't have cirrhosis.I have pancreatic or ampullary cancer.My cancer cannot be surgically removed without risking liver function.I have not had chemotherapy, intra-arterial, or radiotherapy for iCCA, except for capecitabine.I am 18 years old or older.You have a serious illness that could be life-threatening.My cancer has not spread beyond my liver, except for nearby lymph nodes that can be surgically removed.I am fully active or restricted in physically strenuous activity but can do light work.I am not pregnant or breastfeeding.My recent lab tests show my organs are functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: gemcitabine, cisplatin and Durvalumab chemotherapy with Yittrium-90
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there presently any opportunities for prospective participants to join this experiment?
"According to clinicaltrials.gov, this medical study is not recruiting at present as the last update was on October 26th 2022 and it was originally posted November 1st 2022. Nevertheless, there are 199 other trials that do need patient enrolment immediately."
Answered by AI
Is the FDA sanctioning Induction Chemotherapy Triplet Therapy?
"Our team at Power assessed the safety of Induction Chemotherapy Triplet Therapy to be a 2 as this is only in Phase 2, thus having evidence for its safety but not efficacy yet."
Answered by AI
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