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New treatment option for Pancreatic Ductal Adenocarcinoma
Official title A Study of NALIRIFOX in Combination With Radiation Therapy in People With Pancreatic Ductal Adenocarcinoma (PDAC)
ClinicalTrials.gov ID: NCT05851924
What this study is testing
What is NALIRIFOX?
NALIRIFOX is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pancreatic ductal adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The researchers are doing this study to find out whether using the chemotherapy regimen NALIRIFOX in combination with ablative dose radiation therapy (AD-XRT) and the standard chemotherapy drug capecitabine is an effective treatment approach for people with locally advanced or borderline resectable pancreatic ductal adenocarcinoma (PDAC) before surgery. This type of treatment approach is called total neoadjuvant therapy (TNT).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject has been informed about the nature of the study, has agreed to participate in the study, and has signed the informed consent form before...
- Individuals with a history of other malignancies are eligible if they have been disease-free for at least 2 years and are deemed by the investigator...
- A multidisciplinary discussion has been undertaken/planned which can include (a) discussion with medical/surgery oncology, (b)...
- Male or nonpregnant and nonlactating female aged ≥18 years.
- Women of child-bearing potential (i.e., fertile, following menarche, and until becoming postmenopausal unless permanently sterile; permanent...
You likely can't join if
- Presence of metastatic pancreatic cancer (M1 disease)
- Any other medical or social condition deemed by the investigator to be likely to interfere with a subject's ability to sign informed consent...
- Unwilling or unable to comply with study procedures and/or study visits.
- Medical co-morbidities, that preclude major abdominal surgery
- Histologic diagnosis other than adenocarcinoma; however, adenosquamous variants are acceptable.
- Receipt of chemotherapy, prior abdominal radiotherapy, and/or definitive resection for pancreatic cancer.
See the full eligibility criteria
- Subject has been informed about the nature of the study, has agreed to participate in the study, and has signed the informed consent form before participation in any study-related activities.
- Individuals with a history of other malignancies are eligible if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with...
- A multidisciplinary discussion has been undertaken/planned which can include (a) discussion with medical/surgery oncology, (b) Hepatopancreaticobiliary Disease Management Team conference presentation, (c) direct...
- Male or nonpregnant and nonlactating female aged ≥18 years.
- Women of child-bearing potential (i.e., fertile, following menarche, and until becoming postmenopausal unless permanently sterile; permanent sterilization methods include hysterectomy, bilateral salpingectomy, and...
- Female people of reproductive potential must agree to use two effective methods of birth control during the study and for 9 months after the last dose of study medication.
- Male people must agree to use condoms during the study and for 4 months after the last dose of study medication' Disease-specific
- Histologically or cytologically confirmed PDAC that has not been previously treated.
- Radiographically BR or LA PDAC in accordance with the NCCN 2.2021 definition, without evidence of distant metastases by CT.
- Inoperable status after surgical exploration due to presence of locally advanced, unresectable disease without metastases, in patients who have recovered from surgery, is allowed.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Hematological, biochemical, and organ function
- Absolute neutrophil count (ANC) ≥1500/mm\^3 without the use of hemopoietic growth factors within 7 days before treatment
- Platelet count ≥100,000/mm\^3 .
- International normalized ratio (INR) \<1.5 unless the patient is receiving anticoagulation therapy, in which case a therapeutic INR is acceptable. Anticoagulation therapy with low-molecularweight heparin or warfarin...
- Adequate renal function, as evidenced by serum/plasma creatinine level \<1.6 mg/dL
- Presence of metastatic pancreatic cancer (M1 disease)
- Any other medical or social condition deemed by the investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate, and participate in the study or who is likely to interfere with...
- Unwilling or unable to comply with study procedures and/or study visits.
- Medical co-morbidities, that preclude major abdominal surgery
- Histologic diagnosis other than adenocarcinoma; however, adenosquamous variants are acceptable.
- Receipt of chemotherapy, prior abdominal radiotherapy, and/or definitive resection for pancreatic cancer.
- Grade \>2 neuropathy.
- Pregnant and/or nursing.
- Uncontrolled active infection, which would preclude with the exception of resolving cholangitis which in the investigator opinion would render the treatment hazardous.
- Known hypersensitivity to any of the components of the chemotherapeutic agents
- Receipt of concurrent investigational therapy or within 30 days of protocol initiation. Additional criterion for the immunoPET imaging sub-study (n=20)
- Previous anaphylactic reaction to human, humanized or chimeric antibody.
- Refusal or inability to tolerate the scanning procedure (e.g. due to claustrophobia).
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.