Gemcitabine for Cholangiocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cholangiocarcinoma+1 More
Gemcitabine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare a new combination therapy to standard chemotherapy in people with inoperable cholangiocarcinoma. The goal is to see if the new therapy extends life by at least 3 months on average.

Eligible Conditions
  • Cholangiocarcinoma
  • Intrahepatic Cholangiocarcinoma

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 2 years

2 years
Overall survival (OS)
assess progression-free survival (PFS)

Trial Safety

Safety Progress

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

Trial Design

4 Treatment Groups

GemOx alone (Arm 2)
1 of 4
GemOx alone
1 of 4
HAI FUDR plus GemOx (Arm 1)
1 of 4
HAI FUDR plus GemOx
1 of 4

Active Control

Experimental Treatment

164 Total Participants · 4 Treatment Groups

Primary Treatment: Gemcitabine · No Placebo Group · Phase 2

HAI FUDR plus GemOx (Arm 1)Experimental Group · 5 Interventions: Oxaliplatin, Gemcitabine, Implanted Medical Device, Floxuridine (FUDR), Dexamethasone · Intervention Types: Drug, Drug, Device, Drug, Drug
HAI FUDR plus GemOxExperimental Group · 5 Interventions: Oxaliplatin, Gemcitabine, Implanted Medical Device, Floxuridine (FUDR), Dexamethasone · Intervention Types: Drug, Drug, Device, Drug, Drug
GemOx alone (Arm 2)ActiveComparator Group · 2 Interventions: Oxaliplatin, Gemcitabine · Intervention Types: Drug, Drug
GemOx aloneActiveComparator Group · 2 Interventions: Oxaliplatin, Gemcitabine · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxaliplatin
FDA approved
Gemcitabine
FDA approved
Implanted Medical Device
2019
N/A
~80
Dexamethasone
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,821 Previous Clinical Trials
584,166 Total Patients Enrolled
10 Trials studying Cholangiocarcinoma
505 Patients Enrolled for Cholangiocarcinoma
Andrea Cercek, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
8 Previous Clinical Trials
1,036 Total Patients Enrolled
1 Trials studying Cholangiocarcinoma
8 Patients Enrolled for Cholangiocarcinoma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a disease that is considered unresectable at the time of preoperative evaluation.
You are considered a candidate for general anesthesia, abdominal exploration and hepatic artery pump placement.
Patients with chronic hepatitis and/or cirrhosis are eligible, but must be Child-Pugh class A.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 5th, 2021

Last Reviewed: November 29th, 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.