Actively Recruiting
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Led by AHS Cancer Control Alberta · Updated on 2025-06-26
62
Participants Needed
1
Research Sites
325 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A single-arm, interventional study combining Immunotherapy and propranolol with/without chemotherapy and propranolol 1. Pancreatic Cancer 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. 2. HCC 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. 3. Biliary Tract Cancer (BTC, Cholangiocarcinoma of the gallbladder or bile ducts) 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.
CONDITIONS
Official Title
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older
- Body weight greater than 30 kg
- Life expectancy of at least 12 weeks
- Diagnosed with advanced pancreatic adenocarcinoma, hepatocellular carcinoma, or biliary tract cancer not suitable for curative treatment
- Completed radiation therapy at least 4 weeks before starting study treatment with toxicities recovered to grade 1 or less
- Able to provide informed consent
- Performance status of ECOG 0-2
- Measurable disease according to RECIST v1.1 criteria
- Women of child-bearing potential must have a negative pregnancy test at screening
- Men and women of reproductive potential must use effective birth control during the study and for 6 months after last dose
- Female patients who are breastfeeding must stop nursing before the first dose and for a specified period after treatment
- Male patients must agree not to donate sperm during the study and for 6 months after last dose
- No conditions that would prevent compliance with study procedures
- Adequate organ function as defined by specific blood counts, kidney and liver function tests
You will not qualify if you...
- Prior palliative systemic treatment for advanced cancer
- History of pneumonitis requiring steroids
- History of active interstitial lung disease
- For HCC patients, Child Pugh status other than A
- Active cardiovascular disease including recent stroke, heart attack, unstable angina, heart failure, or serious arrhythmia
- Uncontrolled illnesses such as infections, heart failure, hypertension, severe psychiatric conditions
- Prolonged QT interval on ECG when relevant
- History of other malignancies unless disease-free for 3 years or specific exceptions
- Active brain metastases or leptomeningeal disease unless stable and off steroids
- Current use of immunosuppressive medications except certain allowed steroids
- Prior organ transplantation
- Active autoimmune diseases requiring immunosuppressive treatment
- Active infections including hepatitis B, C, or HIV with specific criteria
- Severe allergic reactions to study drugs
- Other severe medical conditions or laboratory abnormalities increasing risk
- Persisting toxicity from prior therapies above grade 1 except certain mild toxicities
- Enrollment in other clinical trials with interfering treatments
- Pregnant or breastfeeding women or those unwilling to use birth control
- Recent major surgery within 28 days before first dose
- Receipt of live vaccine within 30 days before first dose
- Prior participation in durvalumab or tremelimumab trials
- Asthma requiring corticosteroid inhalers with recent hospital admission
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cross Cancer Institute
Edmonton, Alberta, Canada
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here