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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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants with R0 resection
Secondary outcome measures
Number of participants with treatment related serious adverse events
Overall survival
Pathologic complete response
+1 more

Side effects data

From 2017 Phase 2 trial • 32 Patients • NCT01839799
82%
fatigue
82%
diarrhea
76%
nausea
59%
vomiting
59%
neutropenia
41%
neuropathy
35%
mucositis
35%
dehydration
35%
Mouth Sores
29%
decreased wbc
29%
fever
29%
gas
29%
abdominal pain
29%
hypokalemia
24%
Fever
24%
constipation
24%
hyperglycemia
18%
Insomnia
18%
decreased plt
18%
decreased neutrophils
18%
Nausea
18%
Vomiting
18%
Diarrhea
18%
rash
18%
anorexia
18%
weight loss
18%
UTI
18%
Decreased Platlets
12%
hypotension
12%
Dizziness
12%
hypoalbuminemia
12%
Decreased Appetite
12%
Abdominal pain
12%
decrease wbc
12%
anemia
12%
dysgeusia
12%
Alopecia
12%
Anxiety
12%
peripheral neuropathy
12%
Depression
6%
ratiation dermatitis
6%
hypersensitivity reaction
6%
abdominal cramping
6%
Ear Bleed -L-ear
6%
increased Ast
6%
Muscle twitching
6%
loose stools/intermittent
6%
decreased appetite
6%
paronychia
6%
elevated ALK Phos
6%
Runny nose
6%
protein malnutrition
6%
Viral Syndrome
6%
GI Bleed
6%
Syncope
6%
hepatic infection (SAE)
6%
Non-neutropenic fever
6%
Dehydration
6%
Thrombocytopenia
6%
increased abd distention
6%
CMV
6%
thrombocytopenia
6%
headache
6%
dry skin
6%
skin infection port
6%
abd/cramping/pain
6%
hiccoughs
6%
gout
6%
Lightheadeness
6%
night sweats
6%
flatulance
6%
Thick feeling tongue
6%
Cold Sensitivity
6%
Nasal Congestion
6%
Tunnel Vision
6%
Chest Pressure/Spasm
6%
Gastric Ulcer
6%
Neutropenia
6%
Urinary Incontinence
6%
hypomagnesium
6%
Myalgia
6%
Dyspepsia
6%
Loose bowel movement
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1
Arm 2

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
~790
Losartan
FDA approved
Nivolumab
FDA approved
SBRT
2014
Completed Phase 2
~1060
Surgery
2000
Completed Phase 3
~2550

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,955 Previous Clinical Trials
13,212,510 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,652 Previous Clinical Trials
4,130,581 Total Patients Enrolled
Stand Up To CancerOTHER
51 Previous Clinical Trials
40,168 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+Losartan:SBRT+Nivolumab+Losartan:Sur, FOLFIRINOX x 8 : SBRT + Nivolumab : Surgery, FOLFIRINOX: SBRT: Surgery, FOLFIRINOX+Losartan:SBRT+Losartan:Surgery
~24 spots leftby Jul 2025