Arm A (nab-paclitaxel, cisplatin, gemcitabine, infigratinib) for Stage 0 Intrahepatic Cholangiocarcinoma AJCC v8

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Emory University Hospital Midtown, Atlanta, GA
Stage 0 Intrahepatic Cholangiocarcinoma AJCC v8+5 More
Cisplatin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase II trial assesses the feasibility (including both safety and tolerability) of conducting Next Generation Sequencing and administering targeted therapy (infigratinib) in the preoperative setting for patients with intrahepatic cholangiocarcinoma that can be removed by surgery (resectable). Chemotherapy drugs, such as nab-paclitaxel, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Targeted therapy with infigratinib will bind to FGFR which can help stop tumor cell growth and cause tumor cell death. Giving chemotherapy and/or targeted therapy before surgery may make the tumor smaller for resection and may help prevent the cancer from coming back. If a molecular profiling test shows a genetic change called an FGFR2 fusion, patients receive both chemotherapy and targeted therapy while patients without a FGFR2 fusion just receive chemotherapy. Giving targeted therapy based on molecular profile testing results prior to attempted resection of an intrahepatic cholangiocarcinoma that has a risk for either not being able to be removed or for coming back after it has been removed may help improve treatment outcomes.

Eligible Conditions

  • Stage 0 Intrahepatic Cholangiocarcinoma AJCC v8
  • Stage I Intrahepatic Cholangiocarcinoma AJCC v8
  • Stage III Intrahepatic Cholangiocarcinoma AJCC v8
  • Stage II Intrahepatic Cholangiocarcinoma AJCC v8
  • Resectable Intrahepatic Cholangiocarcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Stage 0 Intrahepatic Cholangiocarcinoma AJCC v8

Study Objectives

3 Primary · 5 Secondary · Reporting Duration: Up to 3 years

Year 3
Recurrence-Free Survival
Year 3
Overall Survival
Up to 3 years
Circulating Tumor Deoxyribonucleic Acid Response
Feasibility of Completing All Preoperative Testing and Therapy
Pathologic Response Rate
Radiological Response Rate by Response Evaluation Criteria in Solid Tumors
Safety and Tolerability
Unacceptable Toxicity

Trial Safety

Safety Progress

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

Other trials for Stage 0 Intrahepatic Cholangiocarcinoma AJCC v8

Trial Design

2 Treatment Groups

Arm B (nab-paclitaxel, cisplatin, gemcitabine)
1 of 2
Arm A (nab-paclitaxel, cisplatin, gemcitabine, infigratinib)
1 of 2
Active Control
Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Arm A (nab-paclitaxel, cisplatin, gemcitabine, infigratinib) · No Placebo Group · Phase 2

Arm A (nab-paclitaxel, cisplatin, gemcitabine, infigratinib)Experimental Group · 4 Interventions: Cisplatin, Nab-paclitaxel, Infigratinib Phosphate, Gemcitabine Hydrochloride · Intervention Types: Drug, Drug, Drug, Drug
Arm B (nab-paclitaxel, cisplatin, gemcitabine)ActiveComparator Group · 3 Interventions: Cisplatin, Nab-paclitaxel, Gemcitabine Hydrochloride · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~3340
Nab-paclitaxel
2014
Completed Phase 3
~2330
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5960

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Trial Background

Shishir Kumar Maithel, Principal Investigator
Principal Investigator
Emory University
Closest Location: Emory University Hospital Midtown · Atlanta, GA
Photo of Atlanta  1Photo of Atlanta  2Photo of Atlanta  3
2014First Recorded Clinical Trial
1 TrialsResearching Stage 0 Intrahepatic Cholangiocarcinoma AJCC v8
117 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a diagnosis of intrahepatic cholangiocarcinoma.
You have a performance status of 0-1.
The absolute neutrophil count (ANC) is greater than 1,500 cells/ul.
The patient has a serum total bilirubin level of less than 1.5 times the upper limit of normal.

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.