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Immunomodulator

Immunomodulation Therapy for Hepatopancreaticobiliary Cancer (PRIMe Trial)

N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of surgery to day of discharge after surgery, assessed until day of discharge after surgery occurs
Awards & highlights

PRIMe Trial 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.Check my eligibility
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.See study design
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.

PRIMe Trial 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.
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I expect to stay in the hospital for at least three days after surgery.

PRIMe Trial 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

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

PRIMe 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.

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
654 Previous Clinical Trials
1,543,252 Total Patients Enrolled
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
Hepatopancreaticobiliary Cancer Research Study Groups: Comparator, Group B, Group A
Hepatopancreaticobiliary Cancer 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are involved in the trial thus far?

"Affirmative. Clinicaltrials.gov shows that the trial, which was initially posted on June 16th 2021 is actively seeking participants. 45 individuals will be enrolled from two medical centres for this investigation."

Answered by AI

Is there space to enroll in this experiment at the present moment?

"Affirmative. Clinicaltrials.gov hosts details which verify that this medical trial, originally posted on June 16th 2021, is presently recruiting patients from two sites for a total of 45 people."

Answered by AI
~12 spots leftby Mar 2025