Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT06467565

NALIRIFOX as Induction Therapy in LAPC

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-06-21

20

Participants Needed

1

Research Sites

105 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a prospective, single arm, single center, phase II study of NALIRIFOX as conversion therapy in patients with locally advanced pancreatic cancer.

CONDITIONS

Official Title

NALIRIFOX as Induction Therapy in LAPC

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 70 years, male or female
  • Understand and voluntarily consent to participate in the clinical trial
  • ECOG performance status of 0 or 1
  • Histopathologically or cytologically confirmed pancreatic ductal adenocarcinoma
  • Locally progressive disease as defined by 2022 CSCO guidelines
  • No prior pancreatic tumor resection, chemotherapy, targeted, or immunotherapy treatments
  • At least one measurable pancreatic lesion per RECIST 1.1 criteria
  • Expected survival time of at least 3 months
  • Normal function of heart, lungs, liver, kidneys, and other major organs
  • Hematology values within defined limits without recent blood transfusions or growth factors
  • Blood chemistry within specified limits including bilirubin, liver enzymes, and kidney function
  • No symptoms of cardiac insufficiency greater than NYHA class II and no significant ECG abnormalities
  • Willingness to comply with study protocol and follow-up
  • Use of effective contraception during the trial if of childbearing potential
  • Female participants must not be lactating
Not Eligible

You will not qualify if you...

  • Allergy or intolerance to study drug ingredients
  • Presence of any metastatic lesions
  • Unresolved acute or chronic infections
  • Other cancers within past 5 years except certain skin and cervical cancers
  • Active hepatitis infection
  • Conditions like portal hypertension, gastrointestinal bleeding from tumors, or significant vascular involvement
  • Uncontrolled third space effusions such as large pleural or pericardial effusions, or ascites
  • Mental illness or poor compliance preventing cooperation
  • Severe organ diseases or failures leading to chemotherapy intolerance
  • Abnormal blood clotting or bleeding disorders
  • Significant heart disease, arrhythmias, or related medications
  • Renal insufficiency or high urine protein levels
  • Organ transplant recipients
  • Drug addiction, alcoholism, AIDS, or other infectious diseases
  • Long-term corticosteroid or immunosuppressant use
  • Recent vaccinations within 4 weeks excluding COVID-19 vaccines
  • Active hepatitis B or C, HIV, or syphilis infections
  • Pregnancy, breastfeeding, or unwillingness to use effective birth control
  • Inability to complete the trial or unsuitable conditions
  • Use of strong enzyme inhibitors or inducers affecting study drug metabolism unable to be stopped before dosing

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China, 025

Actively Recruiting

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Research Team

R

Rong K Jiang, MD

CONTACT

M

Min Tu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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