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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

28 février 2023

Anticipated End Date

30 septembre 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

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Le Collectif Canadien pour le cholangiocarcinome (C3) est financé par une subvention d'équipe révolutionnaire de la Société Canadienne du cancer en partenariat avec les Instituts de recherche en santé du Canada. Les fonds de la subvention pour le C3 sont gérés par l'Institut de recherche de l'Hôpital d'Ottawa, qui sert d'institut principal pour toutes les opérations collaboratives.

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