NALIRIFOX as Induction Therapy in LAPC (NCT06467565) | Clinical Trial Compass
UnknownPhase 2
NALIRIFOX as Induction Therapy in LAPC
China20 participantsStarted 2023-12-25
Plain-language summary
This is a prospective, single arm, single center, phase II study of NALIRIFOX as conversion therapy in patients with locally advanced pancreatic cancer.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years old, ≤ 70 years old, male or female;
. Understand the objectives and benefits and risks of the clinical trial, voluntarily participate in and sign the informed consent form;
. ECOG score 0-1;
. The subject had histopathologically or cytologically confirmed type of pancreatic ductal adenocarcinoma
. Local progression according to the 2022 CSCO guidelines;
. Initial subjects with locally advanced pancreatic cancer who have not undergone resection of pancreatic tumor (except open exploration or internal drainage surgery), chemotherapy, targeted, or immunotherapy.
. At least one measurable pancreatic lesion per RECIST 1.1 criteria;
. Expected survival time ≥ 3 months.
Exclusion criteria
. Known allergy or intolerance to the ingredients or excipients of this investigational product.
. Any metastatic lesions.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate (ORR)
Timeframe: Up to 1 year
Trial details
NCT IDNCT06467565
SponsorThe First Affiliated Hospital with Nanjing Medical University
. Patients with unresolved acute or chronic infection
. Other malignancies within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
. Active hepatitis.
. Patients with portal hypertension or cavernous transformation of the portal vein; patients with gastrointestinal bleeding caused by tumor involving the digestive tract; patients with intra-abdominal fistula or abscess due to tumor involvement of digestive tract; the tumor encircles the celiac trunk or SMA and causes significant vascular wall involvement (worm-like changes);
. Presence of third space effusion that cannot be controlled by drainage or other means (e.g., moderate-large pleural effusion, moderate-large pericardial effusion, ascites); a small amount of pleural effusion or ascites that is not clinically symptomatic and does not require clinical intervention should be strictly controlled before enrollment.
. Mental illness or mental disorder, poor compliance, unable to cooperate with treatment