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Chemotherapy

Combined Therapy for Pancreatic Cancer

Phase 2
Waitlist Available
Led By Theodore S. Hong, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 years
Histologically confirmed localized pancreatic adenocarcinoma; borderline/potentially resectable or locally advanced
Must not have
History of allergic reactions attributed to compounds of similar chemical or biologic composition to 5-fluorouracil, irinotecan, oxaliplatin, or losartan
Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until the time of death, up to approximately 6 years
Awards & highlights

Summary

This trial is testing to see if the combination of these interventions can effectively treat pancreatic tumors.

Who is the study for?
This trial is for adults over 18 with localized pancreatic adenocarcinoma that's potentially resectable or advanced. Participants must have stable blood pressure, normal organ/marrow function, and an ECOG status of 0-1. Women should use contraception; those pregnant or breastfeeding are excluded. People can't join if they've had certain allergic reactions, severe infections like TB, HIV/AIDS, uncontrolled health issues, recent major surgery without recovery, prior treatments for their tumor or live vaccines within a month.
What is being tested?
The study tests a combination treatment for pancreatic cancer including FOLFIRINOX (a mix of four drugs), Losartan (a blood pressure medication), Nivolumab (an immunotherapy drug), radiation therapy and surgery to see how well they work together in treating the tumor.
What are the potential side effects?
Possible side effects include reactions to the chemotherapy drugs such as nausea, fatigue, low blood counts leading to increased infection risk; high blood pressure from Losartan; immune-related effects from Nivolumab like inflammation in organs; and typical risks associated with radiation therapy and surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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My pancreatic cancer is confirmed and may be operable or advanced but not spread.
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I have been on a stable dose of dexamethasone (2 mg or less) for at least 7 days.
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I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic to certain chemotherapy drugs or losartan.
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I had major surgery less than 4 weeks ago and haven't fully recovered.
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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
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I have or had lung inflammation not caused by an infection.
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I have an active tuberculosis infection.
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I have received treatments like chemotherapy for my pancreatic tumor.
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I have issues with my digestive system that affect how I absorb food.
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I am not taking cimetidine, as it can affect my cancer treatment.
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I have a bleeding disorder that is not under control.
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I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks.
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I have not received a live vaccine in the last 30 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until the time of death, up to approximately 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until the time of death, up to approximately 6 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
Proportion of participants with R0 resection
Secondary study objectives
Number of participants with treatment related serious adverse events
Overall survival
Pathologic complete response
+1 more

Side effects data

From 2023 Phase 2 trial • 19 Patients • NCT01595321
100%
Bone pain
100%
Febrile neutropenia
100%
Lymphocyte count decreased
100%
Fatigue
100%
Chills
100%
Diarrhea
67%
Anorexia
67%
Neutrophil count decreased
67%
White blood
67%
Abdominal pain
67%
Epistaxis
67%
Vomiting
67%
Dry Skin
67%
Hypomagnesemia
67%
Weight loss
67%
Hypokalemia
67%
Nausea
67%
Alopecia
67%
Anemia
67%
Flatulence
67%
Platelet count decreased
33%
Hypocalcemia
33%
Skin and Subcutaneous Tissue disorder
33%
Wound dehiscence
33%
Fecal incontinence
33%
Gastrointestinal pain
33%
Headache
33%
Hearing imaired
33%
Hypoalbuminemia
33%
Lip infection
33%
Atelectasis
33%
Concentration impairment
33%
Dysgeusia
33%
Pain
33%
Somnolence
33%
Sore throat
33%
Agitation
33%
Dizziness
33%
Fall
33%
Gastroesophageal reflux disease
33%
Peripheral motor neuropathy
33%
Sinus tachycardia
33%
Bruising
33%
Small intestinal obstruction, partial
33%
Decreased breath sounds
33%
Dehydration
33%
Fever
33%
Hoarseness
33%
Hypophosphatemia
33%
Insomnia
33%
Mucositis (oral ulcers)
33%
Ascities
33%
Skin tears
33%
Syncope
33%
Hepatic infection
33%
Lower gastrointestinal hemorrhage
33%
Peripheral sensory neuropathy
33%
Pleural effusion
33%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: SBRT and FOLFIRINOX
Cohort 2: SBRT and Modified FOLFIRINOX
Cohort 3: CY, GVAX, SBRT, and Modified FOLFIRINOX

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: FOLFIRINOX+Losartan:SBRT+Nivolumab+Losartan:SurExperimental Treatment5 Interventions
The FOLFIRINOX regimen will be administered intravenously. Treatment will be every 14 days +3/ -1 at physician discretion * Losartan will be administered orally as a tablet to be taken by the patient at home every day * SBRT should be administered 2-6 weeks after completing chemotherapy * Participants will receive nivolumab during SBRT * All participants will undergo an attempt at definitive surgical resection following SBRT
Group II: FOLFIRINOX+Losartan:SBRT+Losartan:SurgeryExperimental Treatment4 Interventions
The FOLFIRINOX regimen will be administered intravenously. Treatment will be every 14 days +3/ -1 at physician discretion * Losartan will be administered orally as a tablet to be taken by the patient at home every day * SBRT should be administered 2-6 weeks after completing chemotherapy * All participants will undergo an attempt at definitive surgical resection following SBRT
Group III: FOLFIRINOX x 8 : SBRT + Nivolumab : SurgeryExperimental Treatment4 Interventions
* The FOLFIRINOX regimen will be administered intravenously. Treatment will be every 14 days +3/ -1 at physician discretion * SBRT should be administered 2-6 weeks after completing chemotherapy * Participants will receive nivolumab during SBRT * All participants will undergo an attempt at definitive surgical resection following SBRT
Group IV: FOLFIRINOX: SBRT: SurgeryActive Control3 Interventions
The FOLFIRINOX regimen will be administered intravenously. Treatment will be every 14 days +3/ -1 at physician discretion * SBRT should be administered 2-6 weeks after completing chemotherapy * All participants will undergo an attempt at definitive surgical resection following SBRT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FOLFIRINOX
2013
Completed Phase 3
~800
Nivolumab
FDA approved
SBRT
2014
Completed Phase 2
~1060
Surgery
2000
Completed Phase 3
~2490
Losartan
FDA approved

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,993 Previous Clinical Trials
13,230,553 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,678 Previous Clinical Trials
4,125,477 Total Patients Enrolled
Stand Up To CancerOTHER
51 Previous Clinical Trials
39,935 Total Patients Enrolled

Media Library

5-Fluorouracil (5-FU) (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03563248 — Phase 2
Pancreatic Cancer Clinical Trial 2023: 5-Fluorouracil (5-FU) Highlights & Side Effects. Trial Name: NCT03563248 — Phase 2
5-Fluorouracil (5-FU) (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03563248 — Phase 2
Pancreatic Cancer Research Study Groups: FOLFIRINOX x 8 : SBRT + Nivolumab : Surgery, FOLFIRINOX+Losartan:SBRT+Nivolumab+Losartan:Sur, FOLFIRINOX: SBRT: Surgery, FOLFIRINOX+Losartan:SBRT+Losartan:Surgery
~24 spots leftby Sep 2025
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