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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to five years for reporting.

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 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

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Dyspnoea

Cerebral infarction

Ischaemic stroke

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

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

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