RecruitingPhase 2

Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)

Canada62 participantsStarted 2023-07-05

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients must be 18 years of age or older.
✓. Body Weight \>30kg
✓. Life expectancy of at least 12 weeks
✓. Patients must have a diagnosis of histologically documented advanced pancreatic adenocarcinoma, hepatocellular carcinoma, or BTC not amenable to curative intent local therapy or surgery. For the histologies there must only one histology type present ie not mixed cholangiocarcinoma/HCC. For the HCC cohort if tissue biopsy if histological diagnosis is not possible, diagnosis can be made clinically by American Association for the study of liver diseases (AASLD) criteria in cirrhotic patients.
✓. Radiation therapy (palliative or curative) must have been completed at least 4 weeks prior to first study treatment and patients must have toxicities recovered to grade 1 or less.
✓. Patients must be capable of providing consent to enrolment and treatment.
✓. Patients with a performance status of ECOG 0-2(15) will be eligible for enrolment (see Appendix 1).
✓. Measurable disease must be present according to RECIST criteria V1.1(16) (see Appendix 3).

Exclusion criteria

What they're measuring

Investigating and establishing the efficacy of propranolol in boosting the effects of immunotherapy in pancreatic adenocarcinoma

Timeframe: Assessed one year after enrollment of last participant

Investigating and establishing the efficacy of propranolol in boosting the effects of immunotherapy in hepatocellular carcinoma

Timeframe: Assessed one year after enrollment of last participant

Investigating and establishing the efficacy of propranolol in boosting the effects of immunotherapy in biliary tract tumors

Timeframe: Assessed one year after enrollment of last participant

Trial details

NCT IDNCT05451043

SponsorAHS Cancer Control Alberta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-01

View on ClinicalTrials.gov More Pancreatic Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients must be 18 years of age or older.
✓. Body Weight \>30kg
✓. Life expectancy of at least 12 weeks
✓. Patients must have a diagnosis of histologically documented advanced pancreatic adenocarcinoma, hepatocellular carcinoma, or BTC not amenable to curative intent local therapy or surgery. For the histologies there must only one histology type present ie not mixed cholangiocarcinoma/HCC. For the HCC cohort if tissue biopsy if histological diagnosis is not possible, diagnosis can be made clinically by American Association for the study of liver diseases (AASLD) criteria in cirrhotic patients.
✓. Radiation therapy (palliative or curative) must have been completed at least 4 weeks prior to first study treatment and patients must have toxicities recovered to grade 1 or less.
✓. Patients must be capable of providing consent to enrolment and treatment.
✓. Patients with a performance status of ECOG 0-2(15) will be eligible for enrolment (see Appendix 1).
✓. Measurable disease must be present according to RECIST criteria V1.1(16) (see Appendix 3).

Exclusion criteria

What they're measuring

Investigating and establishing the efficacy of propranolol in boosting the effects of immunotherapy in pancreatic adenocarcinoma

Timeframe: Assessed one year after enrollment of last participant

Investigating and establishing the efficacy of propranolol in boosting the effects of immunotherapy in hepatocellular carcinoma

Timeframe: Assessed one year after enrollment of last participant

Investigating and establishing the efficacy of propranolol in boosting the effects of immunotherapy in biliary tract tumors

Timeframe: Assessed one year after enrollment of last participant