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FOLFIRINOX + NIS793 for Pancreatic Cancer
This trial is being done to see if NIS793 is safe and effective to use in combination with the standard of care treatment (FOLFIRINOX) for people with metastatic pancreas adenocarcinoma.
- Pancreatic Cancer Metastatic
- Pancreatic Cancer
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Side effects dataFrom 2013 Phase 3 trial • 688 Patients • NCT00424255
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Who is running the clinical trial?
- You have confirmed advanced or poorly differentiated pancreatic cancer and have not received any treatment for it before.You are 18 years old or older.You are able to perform daily activities without needing much help.Your blood counts, liver function, and kidney function must be within a certain range to participate in the study.You have received any previous treatments for metastatic pancreas adenocarcinoma, such as chemotherapy, radiation therapy, immunotherapy, or other experimental therapies.If you had hepatitis C in the past, you must have completed treatment and no longer have the virus. If you are currently being treated for hepatitis C, you can join the study if the virus is not detectable in your blood.You can join the study if recent brain scans show that treated brain tumors are not getting worse, or if the doctor believes that immediate treatment for new or growing brain tumors is not needed right now.To join this study, participants must have a certain level of health, class 2 B or better.If you have HIV, you can join the trial if you are taking medicine that works well and your virus levels have been very low for the past 6 months.You have a history of frequent or severe bleeding, or have had a major bleeding event in the month before starting treatment.You are taking cimetidine, which can affect how your body processes 5FU. If needed, you can switch to a different medication that does not have this effect.You have a heart condition that requires medication to control irregular heartbeats, or a specific type of heart block caused by 5FU treatment.You have had a strong allergic reaction to a specific type of medication called a monoclonal antibody in the past.You have a known history of UGT1A1 gene polymorphism.You have been diagnosed with advanced pancreatic cancer, and have not received any treatment for it before.You have not received any previous chemotherapy, radiation therapy, immunotherapy, targeted therapy, or experimental treatment for your pancreatic tumor.You have certain types of cancers with specific genetic characteristics.You have not fully recovered from side effects of previous cancer treatments, except for hair loss.You cannot join the study if you currently need steroids for uncontrolled brain metastases. However, you may be eligible if you had radiation treatment more than 4 weeks ago and follow-up tests show that the condition is under control.You have had allergic reactions to drugs similar to NIS793, 5-fluorouracil, irinotecan, or oxaliplatin that cannot be managed with the hospital's allergy treatment plan.You have a blood clotting problem that is not being controlled. You cannot be taking full doses of warfarin (coumadin), but you can take other specific blood thinners for treating deep vein blood clots.You have had a live vaccine within 30 days before starting the study, except for certain types of flu shots and non-live COVID vaccines.You have had or currently have another type of cancer that won't affect the evaluation of the study treatment.If you have chronic hepatitis B, the virus in your blood must be undetectable while on treatment.You have a history of heart problems or symptoms, or have been treated with drugs that can harm the heart.
- Group 1: Safety Run-In
- Group 2: FOLFIRINOX
- Group 3: FOLFIRINOX + NIS793
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What dangers may arise from the utilization of Chemoradiation?
"The safety of chemoradiation has been evaluated as a 1 on a scale from 1 to 3 due its Phase 1 status, which implies limited evidence for efficacy and security."
How many individuals have voluntarily enrolled in this clinical experiment?
"Affirmative. Clinicaltrials.gov reflects that recruitment for this medical trial, initially announced on August 9th 2022, is still ongoing. 50 individuals are required across 1 site to fulfill the requirements of the study."
Are there still opportunities to join this research endeavor?
"As attested by clinicaltrials.gov, this trial is actively seeking participants since its launch on August 9th 2022 and subsequent update on the 19th of that same month."
What are the end goals of this clinical experiment?
"The primary outcome of this trial, monitored over a period spanning up to two months after baseline, is R0 Resection Rate. Secondary assessments include Progression-free Survival (PFS), which assesses objective progression or death due to any cause between the date of randomization/registration and last follow-up for living patients; Resection Rate - measuring the percentage of participants who underwent resection at their primary tumour location regardless of residuals; and Overall Survival (OS) - tracking mortality from registration/randomisation until death due to any cause with censoring occurring upon last patient follow-up if still alive. All these outcomes"
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