Induction Chemotherapy Triplet Therapy for Cholangiocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Inova Schar Cancer Institute, Fairfax, VA
Cholangiocarcinoma+1 More
Induction Chemotherapy Triplet Therapy - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this research is to see if combining gemcitabine, cisplatin and nab-paclitaxel chemotherapy treatments with a direct tumor therapy called Yittrium-90, will work better together to shrink the tumor and control cancer.

Eligible Conditions

  • Cholangiocarcinoma
  • Intrahepatic Cholangiocarcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: 48 months

48 months
Assessing Progression Free Survival (PFS)
Disease Control Rate (DCR)
Hepatic Progression-Free Survival (HPFS)
Overall Survival (OS)
safety and toxicity rate
treatment related impact on quality of life
6 months
Assessing the objective response rate (ORR) at 6 months in patients with locally advanced, unresectable intrahepatic cholangiocarcinoma (iCCA)
R0 resection rate
rate of downstaging to surgery

Trial Safety

Safety Progress

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

Trial Design

1 Treatment Group

gemcitabine, cisplatin and nab-paclitaxel chemotherapy with Yittrium-90
1 of 1
Experimental Treatment

16 Total Participants · 1 Treatment Group

Primary Treatment: Induction Chemotherapy Triplet Therapy · No Placebo Group · Phase 2

gemcitabine, cisplatin and nab-paclitaxel chemotherapy with Yittrium-90Experimental Group · 3 Interventions: Concurrent Y-90 treatment, Induction Chemotherapy Triplet Therapy, Consolidation Doublet Therapy: · Intervention Types: Radiation, Drug, Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 48 months
Closest Location: Inova Schar Cancer Institute · Fairfax, VA
Photo of Fairfax  1Photo of Fairfax  2Photo of Fairfax  3
2017First Recorded Clinical Trial
1 TrialsResearching Cholangiocarcinoma
15 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patients with cirrhosis should not have a preexisting diagnosis of cirrhosis
The following laboratory values are within the normal range for your age and gender.
You have histologically and/or cytologically confirmed iCCA that is previously untreated or, if systemic therapy has been rendered for prior disease, has been administered at least 6 months before the development of recurrent or de novo new sites of disease.
You are a male or female at least 18 years of age.
You have measurable disease per RECIST 1.1 at least 2 cm in size.
You have a performance status score of 0 or 1.

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.

References