Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Clinicaltrials.gov ID
NCT05451043
Status
Not Yet Recruiting
Study Type
Interventional, Phase 2
Sponsor
AHS Cancer Control Alberta
Start Date
February 28, 2023
Anticipated End Date
September 30, 2025
Study Contact
TBC
About the Study
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
Pancreatic Cancer
Hepatocellular Cancer
Biliary Tract Cancer
Cholangiocarcinoma
Inclusion/Exclusion Criteria?
Primary, Secondary, Other Outcome Measures??
Locations in Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
About the Study
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
Pancreatic Cancer
Hepatocellular Cancer
Biliary Tract Cancer
Cholangiocarcinoma
Interventions
BIOLOGICAL:
Durvalumab
Tremelimumab
DRUG:
Gemcitabine
Nab paclitaxel
Propranolol
Cisplatin
Locations in Canada
Cross Cancer Institute, Edmonton, Alberta, Canada