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Anti-metabolites
Combination Therapy for Bile Duct Cancer (NEOLANGIO Trial)
Phase 2
Waitlist Available
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically proven intrahepatic cholangiocarcinoma
Complete surgical resection of the tumor must be achievable. Resection should include a portal lymphadenectomy as per standard of care
Must not have
Known additional malignancy that is progressing or has required active treatment within the past 2 years
Locally unresectable tumor or metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial focuses on biliary tract cancer, which is a type of aggressive cancer that affects the bile ducts and gallbladder. It is usually diagnosed at an advanced stage, with a high risk
Who is the study for?
This trial is for patients with a type of bile duct cancer known as iCCA that can be surgically removed. Participants must have not undergone any previous treatments for their condition and should be physically fit enough to handle surgery and chemotherapy.
What is being tested?
The study tests a combination of chemotherapy drugs (Gemcitabine, Cisplatin, Nab-Paclitaxel) with an investigational drug called Rilvegostomig in patients undergoing surgery for iCCA. The goal is to see if this regimen can prevent the cancer from coming back.
What are the potential side effects?
Possible side effects include nausea, vomiting, hair loss, numbness or tingling in hands and feet due to nerve damage (neuropathy), low blood cell counts leading to increased infection risk or bleeding problems, kidney issues, and liver toxicity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is confirmed as bile duct cancer inside the liver.
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My tumor can be completely removed by surgery, including lymph node removal.
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I have not had chemotherapy, targeted therapy, or immunotherapy before.
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My liver cirrhosis is mild.
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I am post-menopausal or not pregnant if pre-menopausal.
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I have provided a recent or archived sample of my tumor for evaluation.
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I am older than 18 years.
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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:Select...
I have another cancer that is getting worse or was treated in the last 2 years.
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My cancer cannot be removed by surgery or has spread to other parts of my body.
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I am currently being treated for an infection.
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I have a history of HIV.
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I am legally unable to make my own decisions.
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I have an immune system disorder or I'm on long-term steroids.
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I am not currently on any cancer treatments like chemotherapy or hormone therapy.
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I have or had lung inflammation that needed steroids.
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I have been treated for an autoimmune disease in the last 2 years.
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I am allergic or cannot take the study drugs due to health reasons.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Major pathological response (MPR), defined as >70% tumor necrosis
Secondary study objectives
Objective response rate (ORR)
Rate of R0
The number of patients who experience a surgical delay and/or drop off due to treatment related adverse events (TRAEs) or progressive disease
+1 moreAwards & 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/Nab-Paclitaxel and RilvegostomigExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,531 Previous Clinical Trials
504,282 Total Patients Enrolled
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Sunnybrook Health Sciences CentreOTHER
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1 Trials studying Cholangiocarcinoma
8 Patients Enrolled for Cholangiocarcinoma
Hamilton Health Sciences CorporationOTHER
377 Previous Clinical Trials
339,889 Total Patients Enrolled