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Gemcitabine for Biliary Cancers

Phase 1
Waitlist Available
Led By Jordan Kharofa, MD
Research Sponsored by Jordan Kharofa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Summary

This study is evaluating whether a new treatment may help reduce the size of tumors in the liver.

Eligible Conditions
  • Biliary Cancers
  • Bile Duct Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Completion of all therapy. Defined as completing 4/6 doses of gem/cis chemo, 80% of RT dose, and surgical resection.
Secondary outcome measures
Lymph node involvement. This will be measured by the Proportion of patients with involved lymph nodes (N0 vs N1).
Margin negative resection rate. This will be measured by the Proportion of patients with involved surgical margins (R1 rate).
Patients will be evaluated for toxicity during protocol therapy and postoperatively using the CTCAE v 5 criteria.
+3 more

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680
51%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Cerebral infarction
1%
Dyspnoea
1%
Ischaemic stroke
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Research TreatmentExperimental Treatment4 Interventions
Gemcitabine/Cisplatin/ChemoRT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
2014
Completed Phase 3
~11540
Cisplatin
2013
Completed Phase 3
~1940
Gemcitabine
2017
Completed Phase 3
~2070

Find a Location

Who is running the clinical trial?

Jordan KharofaLead Sponsor
1 Previous Clinical Trials
14 Total Patients Enrolled
Jordan Kharofa, MDPrincipal Investigator - University of Cincinnati
University Radiology Associates, University of Cincinnati Medical Center
University Of Cincinnati College Of Medicine (Medical School)
1 Previous Clinical Trials
14 Total Patients Enrolled
~0 spots leftby Aug 2025
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