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Immunomodulator

Immunomodulation Therapy for Hepatopancreaticobiliary Cancer (PRIMe Trial)

N/A
Waitlist Available
Led By Paul Karanicolas, MD, PhD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients age 18 and over at time of diagnosis
Resectable presumed liver, pancreas, or bile duct malignancy (i.e., liver metastases, HCC, cholangiocarcinoma, pancreatic or periampullary adenocarcinoma, NETs)as determined by surgeon in clinic
Must not have
Subject with known current liver cirrhosis
Active infection of any site and/or active herpes requiring ongoing treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of surgery to 90-days after surgery

Summary

This trial is testing whether a perioperative immunosupplement can improve immune function following surgery for HPB malignancy.

Who is the study for?
Adults diagnosed with resectable liver, pancreas, or bile duct malignancies who can stay in the hospital for at least three days post-surgery and tolerate oral intake. Excluded are those with significant immunodeficiency, serious illnesses posing high risk, active infections, pregnant/nursing women, fish/shellfish objections or allergies including milk allergy, certain heart conditions or severe asthma.
What is being tested?
The trial is testing if perioperative immunosupplementation (Active A or Active B) versus a placebo oil affects immune function after surgery for HPB cancer. It's a blinded study where patients don't know if they're getting the real treatment or placebo.
What are the potential side effects?
Possible side effects may include allergic reactions especially in individuals with shellfish/milk allergies since supplements could contain these allergens. Other risks might be related to arginine which can worsen asthma symptoms and cause issues in people with certain heart diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was 18 or older when I was diagnosed.
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My liver, pancreas, or bile duct cancer is considered operable by my surgeon.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with liver cirrhosis.
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I do not have any ongoing infections or herpes requiring treatment.
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I have a genetic condition that affects how my body processes certain proteins.
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I have had a heart attack or dangerous heart rhythm problems.
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I have heart problems causing chest pain.
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I have severe asthma not controlled by standard treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of surgery to 90-days after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and day of surgery to 90-days after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Natural killer (NK) cell killing
Secondary study objectives
90-day postoperative complications (Clavien-Dindo 3-5)
90-day postoperative mortality
Incidence of liver insufficiency
+6 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Group AExperimental Treatment2 Interventions
Powdered formula containing whey protein and arginine (Active A) and lipid bolus containing omega 3 fatty acids. Participants will mix the powder (Active A) with 250 mL of water and drink the formula 3 times per day for 5 days. Each drink will be followed by consuming 1 tsp of the lipid bolus. This will be done for 5 days prior to the operation and for 5 days after the operation.
Group II: Group BActive Control2 Interventions
Powdered formula containing whey protein and arginine (Active A) and placebo oil. Participants will mix the powder (Active A) with 250 mL of water and drink the formula 3 times per day for 5 days. Each drink will be followed by consuming 1 tsp of the lipid bolus. This will be done for 5 days prior to the operation and for 5 days after the operation.
Group III: ComparatorPlacebo Group2 Interventions
Powdered formula containing whey protein (Active B) and placebo oil. Participants will mix the powder (Active B) with 250 mL of water and drink the formula 3 times per day for 5 days. Each drink will be followed by consuming 1 tsp of the lipid bolus. This will be done for 5 days prior to the operation and for 5 days after the operation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active A
2021
N/A
~50
Lipid bolus
2021
N/A
~50

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
674 Previous Clinical Trials
1,565,846 Total Patients Enrolled
5 Trials studying Surgery
124,566 Patients Enrolled for Surgery
Enhanced Medical NutritionIndustry Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
Sunnybrook Health Sciences Centre Clinical Research Grant CompetitionUNKNOWN

Media Library

Active A (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT04549662 — N/A
Surgery Research Study Groups: Comparator, Group B, Group A
Surgery Clinical Trial 2023: Active A Highlights & Side Effects. Trial Name: NCT04549662 — N/A
Active A (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04549662 — N/A
~10 spots leftby Nov 2025
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