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Chemotherapy
Immunotherapy + Propranolol + Chemotherapy for Hepatopancreatic Cancer
Phase 2
Waitlist Available
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed one year after enrollment of last participant
Awards & highlights
Study Summary
This trial is testing a new immunotherapy treatment for pancreatic, liver, and biliary tract cancer. The treatment consists of two drugs, durvalumab and tremelimumab, given in combination with propranolol and, in some cases, chemotherapy.
Who is the study for?
Adults with advanced pancreatic, liver, or biliary tract cancers who have measurable disease and a life expectancy of at least 12 weeks. They must not have received prior systemic treatment for their cancer, be able to consent to the trial, use effective birth control if applicable, and meet specific health criteria including organ function tests.Check my eligibility
What is being tested?
The study is testing Durvalumab and Tremelimumab in combination with Propranolol and chemotherapy (Nab paclitaxel + Gemcitabine or Cisplatin) for treating advanced hepatopancreaticobiliary tumors. The drugs are given on different schedules depending on the type of cancer being treated.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, infusion reactions similar to allergic responses, fatigue, digestive issues like nausea or diarrhea, blood disorders such as low counts of certain cell types which can increase infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed one year after enrollment of last participant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed one year after enrollment of last participant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Investigating and establishing the efficacy of propranolol in boosting the effects of immunotherapy in biliary tract tumors
Investigating and establishing the efficacy of propranolol in boosting the effects of immunotherapy in hepatocellular carcinoma
Investigating and establishing the efficacy of propranolol in boosting the effects of immunotherapy in pancreatic adenocarcinoma
Secondary outcome measures
Feasibility of study therapy
Overall Survival
Progression-free survival
+1 moreSide effects data
From 2022 Phase 2 trial • 80 Patients • NCT0301512965%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab
Trial Design
3Treatment groups
Experimental Treatment
Group I: Pancreatic CancerExperimental Treatment5 Interventions
Durvalumab will be administered once every 4 weeks, in combination with gemcitabine + nab-paclitaxel (day 1/8/15) and continuous propranolol. Tremelimumab will be given on day 1 of cycle 1, which may be repeated at the time of progression in eligible patients.
Group II: Hepatocellular CancerExperimental Treatment3 Interventions
Durvalumab will be administered once every 4 weeks in combination with continuous propranolol. Tremelimumab will be given on day 1 of cycle 1, which may be repeated at the time of progression in eligible patients.
Group III: Biliary Tract CancerExperimental Treatment5 Interventions
Durvalumab will be administered once every 3 weeks, in combination with cisplatin + gemcitabine (day 1/8) and continuous propranolol. Tremelimumab will be given on day 1 of cycle 1, which may be repeated at the time of progression in eligible patients.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Gemcitabine
FDA approved
Cisplatin
FDA approved
Durvalumab
FDA approved
Propranolol
FDA approved
Tremelimumab
Not yet FDA approved
Find a Location
Who is running the clinical trial?
AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
36,150 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had pneumonitis treated with steroids.I am not pregnant or breastfeeding and agree to use birth control during and after treatment.I have received treatment to ease symptoms for my advanced cancer.I am able to care for myself and can perform daily activities.My liver function is good despite my liver cancer.I have an ongoing lung condition that affects the tissue and space around the air sacs.I am 18 years old or older.My heart's electrical cycle is within a safe range for certain treatments.I am able to understand and agree to the study's requirements.I agree not to donate sperm during and for 6 months after the study.I have advanced pancreatic, liver, or bile duct cancer that cannot be cured with surgery.I am using or willing to use effective birth control during and 6 months after the study.I can follow the study's schedule and requirements without any issues.I am a woman who can have children and have a negative pregnancy test.I am able to get out of my bed or chair and move around.I haven't had any live vaccines in the last 30 days.I finished radiation therapy at least 4 weeks ago and have mostly recovered.I do not have an active infection needing treatment and meet the specific conditions for hepatitis B, C, and HIV.I use corticosteroid inhalers for asthma and was hospitalized for it in the last year.I haven't had major surgery in the last 28 days, except for minor procedures to relieve symptoms.I have an autoimmune disease but it's not severe and doesn't require immunosuppressive treatment.I finished radiation therapy at least 4 weeks ago and have mostly recovered.I have lasting side effects from past treatments, but they are mild and not dangerous.I am not on strong immune-suppressing drugs, except for low-dose steroids or local treatments.My brain metastases are treated, stable for 6 weeks, and I'm not on steroids or anticonvulsants.I've been cancer-free for 3 years or had certain minor cancers treated successfully.I haven't had a recent serious heart condition or stroke.I do not have any serious ongoing illnesses that would affect my participation in the study.I am a woman who can have children and have a negative pregnancy test.Measurable disease must be present according to RECIST criteria V1.1(16) (see Appendix 3).I am able to understand and agree to the treatment plan.
Research Study Groups:
This trial has the following groups:- Group 1: Biliary Tract Cancer
- Group 2: Pancreatic Cancer
- Group 3: Hepatocellular Cancer
Awards:
This trial has 2 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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.
What objectives is this investigation seeking to accomplish?
"The primary endpoint of the trial, which will be evaluated after one year of patient enrollment, is to assess and affirm the effectiveness of propranolol in augmenting immunotherapy's impact on hepatocellular carcinoma. Secondary objectives are centred around safety/tolerability (i.e., Treatment-related and non-related adverse events per CTCAE v5.0 for advanced hepato-pancreatobiliary tumours, rate of adverse effects leading to dose modifications or discontinuations including immune-mediated reactions), Progression Free Survival (time from treatment initiation till progression or death) and Overall Survival (time from"
Answered by AI
How has Durvalumab been proven to be benign for individuals?
"Durvalumab's safety was assigned a score of 2, as this Phase 2 trial has produced some evidence that it is safe but not yet enough to indicate its efficacy."
Answered by AI
Is enrolment still open for this clinical investigation?
"Per clinicaltrials.gov, this trial is not presently seeking participants. Initially posted on October 1st 2022 and last revised on July 7th 2022, though it may resume recruitment in the future; 1370 other studies are actively recruiting patients as of now."
Answered by AI
Who else is applying?
What state do they live in?
South Carolina
What site did they apply to?
Cross Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
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