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Alkylating Agent
Chemotherapy +/− Infigratinib for Bile Duct Cancer
Phase 2
Waitlist Available
Led By Shishir K. Maithel, MD
Research Sponsored by Emory University
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 up to 3 years
Awards & highlights
Study Summary
This trial is testing if it's safe to give targeted therapy and chemotherapy before surgery to patients with a certain kind of liver cancer.
Who is the study for?
Adults diagnosed with resectable intrahepatic cholangiocarcinoma, who are in good physical condition (ECOG 0-1), and have proper liver, bone marrow, and kidney function. Men must use contraception during treatment and for 6 months after. Women of childbearing potential must avoid pregnancy through abstinence or effective contraception.Check my eligibility
What is being tested?
The trial is testing the effectiveness of preoperative chemotherapy drugs nab-paclitaxel, cisplatin, gemcitabine combined with targeted therapy infigratinib for patients whose tumors can be surgically removed. The aim is to shrink tumors before surgery and prevent recurrence based on genetic markers like FGFR2 fusion.See study design
What are the potential side effects?
Potential side effects include reactions at the infusion site, fatigue, nausea, low blood cell counts increasing infection risk; organ inflammation; abnormal liver enzyme levels; nerve damage causing numbness or pain; eye problems like keratopathy; and changes in calcium/phosphate balance.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of Completing All Preoperative Testing and Therapy
Safety and Tolerability
Unacceptable Toxicity
Secondary outcome measures
DNA
Overall Survival
Pathologic Response Rate
+2 moreSide effects data
From 2016 Phase 3 trial • 50 Patients • NCT0201927770%
Diarrhoea
68%
Fatigue
56%
Neuropathy peripheral
54%
Alopecia
52%
Rash
46%
Nausea
38%
Upper respiratory tract infection
36%
Myalgia
34%
Vomiting
34%
Headache
28%
Muscle spasms
24%
Nail disorder
24%
Gastrooesophageal reflux disease
24%
Epistaxis
24%
Arthralgia
22%
Pain in extremity
20%
Back pain
20%
Urinary tract infection
18%
Dizziness
18%
Cough
18%
Constipation
16%
Neutropenia
16%
Dry skin
14%
Pyrexia
14%
Paronychia
14%
Dysgeusia
14%
Oropharyngeal pain
14%
Pruritus
14%
Hot flush
12%
Hypertension
12%
Dry eye
12%
Stomatitis
12%
Decreased appetite
12%
Musculoskeletal pain
12%
Insomnia
12%
Dyspnoea
10%
Peripheral sensory neuropathy
10%
Abdominal pain
10%
Mucosal inflammation
10%
Lethargy
8%
Febrile neutropenia
8%
Rash pustular
8%
Lacrimation increased
8%
Chills
8%
Anaemia
8%
Oedema peripheral
8%
Oral candidiasis
8%
Sinusitis
8%
Anxiety
8%
Rhinorrhoea
8%
Acne
8%
Erythema
6%
Musculoskeletal chest pain
6%
Injection site reaction
6%
Skin lesion
6%
Conjunctivitis
6%
Nail infection
6%
Chest pain
6%
Tachycardia
6%
Abdominal pain upper
6%
Dry mouth
6%
Dyspepsia
6%
Chest discomfort
6%
Pain
6%
Hypocalcaemia
6%
Bone pain
6%
Depression
6%
Dyspnoea exertional
6%
Dermatitis acneiform
6%
Lymphoedema
6%
Weight decreased
6%
Tooth extraction
4%
Pulmonary embolism
4%
Cellulitis
2%
Psychotic disorder
2%
Syncope
2%
Dermatitis bullous
2%
Gastroenteritis
2%
Femur fracture
2%
Breast cancer
2%
Device related infection
2%
Wound infection
2%
Cardiac failure
2%
Drug hypersensitivity
2%
Gastritis
2%
Dermatomyositis
2%
Oesophagitis
2%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab, Pertuzumab, and Taxane
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (nab-paclitaxel, cisplatin, gemcitabine, infigratinib)Experimental Treatment4 Interventions
While awaiting NGS molecular profile results, all patients receive nab-paclitaxel IV over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine IV over 30 minutes on days 1 and 8 of one 21-day cycle in the absence of disease progression or unacceptable toxicity.
Patients who are FGFR2 fusion/translocation positive receive infigratinib PO QD for days 1-21 of each cycle. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients whose cancer is stable or improved undergo surgery to remove the tumor within 8 weeks of completing preoperative therapy per standard of care.
Group II: Arm B (nab-paclitaxel, cisplatin, gemcitabine)Active Control3 Interventions
While awaiting NGS molecular profile results, all patients receive nab-paclitaxel IV over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine IV over 30 minutes on days 1 and 8 of one 21-day cycle in the absence of disease progression or unacceptable toxicity.
Patients who are FGFR2 fusion/translocation negative continue receiving nab-paclitaxel IV over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine IV over 30 minutes on days 1 and 8 of each cycle. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients whose cancer is stable or improved undergo surgery to remove the tumor within 8 weeks of completing preoperative therapy per standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nab-paclitaxel
2014
Completed Phase 3
~2030
Cisplatin
2013
Completed Phase 3
~1940
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,638 Previous Clinical Trials
2,560,532 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,489 Total Patients Enrolled
4 Trials studying Intrahepatic Cholangiocarcinoma
1,157 Patients Enrolled for Intrahepatic Cholangiocarcinoma
Shishir K. Maithel, MDPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had an allergic reaction or severe sensitivity to any of the study drugs.You currently misuse alcohol or illegal drugs.You have eaten or drunk grapefruit, pomegranate, star fruit, pomelo, or Seville oranges or their juices in the past week before starting the study drug.You have had or currently have another type of cancer, except for certain types like non-melanoma skin cancer, small kidney tumors, small neuroendocrine tumors, or early-stage lung cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (nab-paclitaxel, cisplatin, gemcitabine)
- Group 2: Arm A (nab-paclitaxel, cisplatin, gemcitabine, infigratinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the goals that we hope to achieve with this clinical trial?
"This study's primary goal is to establish the feasibility of completing all preoperative testing and therapy within the 3-year evaluation period. Secondary outcomes being measured include recurrence-free survival (time between date of surgery and disease recurrence or death, whichever occurs first), pathologic response rate (degree of treatment effect to preoperative therapy as percent of viable cancer cells and necrotic cells in resected specimen), and radiological response rate by Response Evaluation Criteria in Solid Tumors (percentage of patients with complete response, partial response, or stable disease after neoadjuvant therapy)."
Answered by AI
Has Nab-paclitaxel been cleared by the FDA for use?
"Nab-paclitaxel's safety is estimated to be a 2. In other words, while there is some clinical evidence supporting its safety, there is none for efficacy."
Answered by AI
Are people still able to sign up for this experimental treatment?
"Unfortunately, this specific trial is no longer looking for new patients according to the most recent update on clinicaltrials.gov from August 19th, 2022. The original posting was on November 23rd, 2020. However, there are 213 other trials that might be a match for you."
Answered by AI
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