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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

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 below

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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:

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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

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

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 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Gemcitabine/Cisplatin/Nab-Paclitaxel and RilvegostomigExperimental Treatment1 Intervention

0 / 18Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,514 Previous Clinical Trials

500,165 Total Patients Enrolled

4 Trials studying Cholangiocarcinoma

98 Patients Enrolled for Cholangiocarcinoma

Sunnybrook Health Sciences CentreOTHER

671 Previous Clinical Trials

1,564,595 Total Patients Enrolled

1 Trials studying Cholangiocarcinoma

8 Patients Enrolled for Cholangiocarcinoma

Hamilton Health Sciences CorporationOTHER

374 Previous Clinical Trials

339,996 Total Patients Enrolled

~27 spots leftby Dec 2027

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