Pancreatic Cancer for Cholangiocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cross Cancer Institute, Edmonton, Canada
Cholangiocarcinoma+6 More
Cisplatin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

A single-arm, interventional study combining Immunotherapy and propranolol with/without chemotherapy and propranolol 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. 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. 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.

Eligible Conditions

  • Cholangiocarcinoma
  • Malignant Neoplasm of Pancreas
  • Biliary Tract Cancer (BTC)
  • Hepatocellular Cancer (HCC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Cholangiocarcinoma

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: 5 years from final study drug dose.

Year 5
Overall Survival
Assessed one year after enrollment of last participant
Feasibility of study therapy
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
Month 30
Progression-free survival
Throughout study treatment, up to a maximum of two years
Safety/tolerability

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Cholangiocarcinoma

Trial Design

3 Treatment Groups

Pancreatic Cancer
1 of 3
Biliary Tract Cancer
1 of 3
Hepatocellular Cancer
1 of 3
Experimental Treatment

62 Total Participants · 3 Treatment Groups

Primary Treatment: Pancreatic Cancer · No Placebo Group · Phase 2

Pancreatic CancerExperimental Group · 5 Interventions: Durvalumab, Nab paclitaxel, Gemcitabine, Propranolol, Tremelimumab · Intervention Types: Biological, Drug, Drug, Drug, Biological
Biliary Tract CancerExperimental Group · 5 Interventions: Cisplatin, Durvalumab, Gemcitabine, Propranolol, Tremelimumab · Intervention Types: Drug, Biological, Drug, Drug, Biological
Hepatocellular CancerExperimental Group · 3 Interventions: Durvalumab, Propranolol, Tremelimumab · Intervention Types: Biological, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~3340
Durvalumab
2017
Completed Phase 2
~3190
Gemcitabine
2017
Completed Phase 3
~2940
Propranolol
2010
Completed Phase 4
~1490
Tremelimumab
2017
Completed Phase 2
~3370

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years from final study drug dose.
Closest Location: Cross Cancer Institute · Edmonton, Canada
Photo of Edmonton  1Photo of Edmonton  2Photo of Edmonton  3
2011First Recorded Clinical Trial
3 TrialsResearching Cholangiocarcinoma
401 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are capable of giving informed consent to enrolment and treatment.
Measurable disease must be present according to RECIST criteria V1.1(16) (see Appendix 3).
Women of child-bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening.
You have an age of 18 years or older.
You must be able to complete the study for at least 12 weeks.
You have a diagnosis of histologically documented advanced pancreatic adenocarcinoma, hepatocellular carcinoma, or BTC not amenable to curative intent local therapy or surgery.
Patients (men and women) of childbearing / reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period and for a period of 6 months after the last dose of study drug.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.