Your session is about to expire
← Back to Search
Anti-metabolites
Intra-arterial vs. IV Chemotherapy for Pancreatic Cancer (TIGeR-PaC Trial)
Phase 3
Recruiting
Research Sponsored by RenovoRx
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 1 year
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial tests different ways to treat advanced pancreatic cancer that can't be removed by surgery. It uses a combination of chemotherapy drugs and radiation, then compares direct artery chemotherapy to other treatments.
Who is the study for?
This trial is for adults with newly diagnosed, locally advanced pancreatic cancer that can't be surgically removed. They should have a life expectancy over 12 weeks, good physical function, and proper organ function. Women must not be pregnant and agree to contraception use. People are excluded if they've had certain treatments or surgeries recently, have metastatic disease or other cancers within the last year, severe infections or heart conditions in recent months, HIV/hepatitis, or allergies to the drugs being tested.
What is being tested?
The study compares two ways of delivering chemotherapy for pancreatic cancer: directly into the artery feeding the tumor (intra-arterial) using RenovoCath versus standard IV infusion. Both groups will receive Gemcitabine and nab-Paclitaxel following radiotherapy to see which method is more effective.
What are the potential side effects?
Possible side effects include reactions at the infusion site, low blood counts leading to increased infection risk and bleeding problems, fatigue, kidney issues from high creatinine levels; allergic reactions; gastrointestinal symptoms like nausea; liver function abnormalities; and potential complications from catheter placement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to five years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to five years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Survival
Secondary study objectives
Frequency of neutropenia
Health Related Quality of Life
Neuropathy Assessment
+5 moreSide effects data
From 2012 Phase 3 trial • 256 Patients • NCT0100568051%
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%
Ischaemic stroke
1%
Dyspnoea
1%
Cerebral infarction
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)
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: IA TherapyExperimental Treatment2 Interventions
IA Treatments with 1,000 mg/m2 gemcitabine administered through RenovoCath every other week for a maximum of 8 treatments for approximately 16 weeks.
Group II: IV TherapyActive Control2 Interventions
IV gemcitabine and nab-paclitaxel will be administered for 16 weeks on days 1, 8, and 15 of a 28 day cycle. Nab-paclitaxel will be administered intravenously following pre-medication at a dose of 125 mg/m2 over 30 minutes followed by an infusion of gemcitabine at a dose of 1000 mg/m2 over 30 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~1920
Find a Location
Who is running the clinical trial?
RenovoRxLead Sponsor
2 Previous Clinical Trials
45 Total Patients Enrolled
Michael J PishvaianStudy ChairJohns Hopkins Kimmel Cancer Center