Resection/Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma

NCT07340151 | Recruiting DMC

• 1 other identifier: CTMS# 25-0006
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical trial that tests a surgical treatment. Everyone in the study will get the same treatment, and there is no comparison or placebo group. Patients can join the study if they have pancreatic cancer that has spread to only a few spots in the liver or lungs. They must be receiving a type of chemotherapy called NALIRIFOX before surgery (this is called neoadjuvant chemotherapy). If the cancer gets worse during or after the first 4 cycles of chemotherapy, the patient will be removed from the study. If the cancer stays the same or gets smaller after the first 4 cycles, doctors will check if the main tumor can be removed with surgery. If the tumor cannot be removed, the patient will get 4 more cycles of chemotherapy as standard of care. If the main tumor can be removed, the patient will have surgery 2-6 weeks after finishing chemotherapy. During surgery, doctors will try to remove both the main tumor and the small tumors in the liver or lungs. If, during surgery, the doctor finds that the main tumor actually cannot be removed, the patient may receive 4 more cycles of chemotherapy starting 2-4 weeks after surgery.

Conditions

Adenocarcinoma of the Pancreas

Keywords

Oligometastatic disease; Hepatic oligometastatic adenocarcinoma of the pancreas; Pulmonary oligometastatic adenocarcinoma of the pancreas; Surgical resection

Outcome Measures

Primary Outcomes (1)

• Efficacy of R0/R1 resection

  Assessed by tumor imaging

  Prior to surgery to 4-12 weeks after surgery

Secondary Outcomes (6)

• Safety of surgical resection of synchronous pulmonary or hepatic oligometastatic ductal adenocarcinoma

  End of surgical procedure

• European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-30)

  Prior to surgery and 4-12 weeks after surgery

• European Organization for Research and Treatment of Cancer Quality of Life for pancreatic ductal adenocarcinoma (EORTC QLQ-PAN26)

  Prior to surgery and 4-12 weeks after surgery

• Progression-free survival (PFS)

  Up to 25 months after re-section of tumor

• Recurrence-free survival (RFS)

  Up to 25 months after re-section of tumor

Other Outcomes (1)

• Time to development of new/recurrent metastases

  Up to 25 months after re-section of tumor

Study Arms (2)

Lung Oligometastatic Cohort

ACTIVE COMPARATOR

Participants who have pulmonary oligometastatic pancreatic tumor

Procedure: Surgical resection

Liver Oligometastatic Cohort

ACTIVE COMPARATOR

Participants who have hepatic oligometastatic pancreatic tumor

Procedure: Surgical resection

Interventions

Surgical resection PROCEDURE

Patients with a technically resectable primary tumor and tumor response or stable disease of their metastatic disease according to the evaluation of an interdisciplinary tumor board after the first 4 cycles will undergo exploratory laparotomy and synchronous or staged resection of the primary tumor and the hepatic or pulmonary metastases by using the standard of care surgical techniques 2-6 weeks after the last neoadjuvant chemotherapy. Residual tumor classification, also known as R Classification defines how complete the resection of the malignancy has been at surgery: R0: no residual tumor/R1: microscopic residual tumor

Also known as: R0/R1 resection

Liver Oligometastatic Cohort; Lung Oligometastatic Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of treatment-naïve limited hepatic or pulmonary metastatic adenocarcinoma of the pancreas
• Meet the definition of limited hepatic or pulmonary metastasis according to Computed Tomography/Magnetic Resonance Imaging (CT/MRI) that is done prior to the starting of any anticancer treatment. Either CT scan of chest, abdomen, and pelvis with intravenous contrast or a combination of MRI of abdomen and pelvis and CT scan of chest is acceptable radiographic imaging. CT/MRI can be done at an outside facility but must be reviewed by a local radiologist.
• Definition of limited hepatic metastasis: 1 to 5 metastases in CT/MRI, which are potentially resectable or treatable by ablative procedures.
• Definition of limited pulmonary metastasis: 1 to 4 pulmonary nodules seen on CT/MRI, suspicious for pulmonary metastases as per the multidisciplinary tumor board radiologist and surgeon.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Patients ≥18 years at the time of signing the informed consent
• Being a candidate for chemotherapy with NALIRIFOX
• Patient's written informed consent prior to any trial-specific procedure
• Patient's legal capacity to consent to participation in the clinical trial.

You may not qualify if:

• Acinar cell carcinoma and/or neuroendocrine carcinoma of the pancreas
• Symptomatic clinically significant ascites
• Evidence of simultaneous pulmonary and hepatic metastases
• Any tumor-specific pretreatment of the adenocarcinoma of the pancreas (including but not limited to surgery, radiation therapy, chemotherapy or ablative procedures). Currently being on NALIRIFOX or its modified form is allowed, unless more than 2 treatments of NALIRIFOX have been given.
• Any malignancies other than adenocarcinoma of the pancreas in the 2 years before the start of the clinical trial except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, breast cancer, prostate cancer or superficial bladder tumors (Ta, Tis and T1 staging where Ta=non-invasive; Tis=high-grade, flat non-invasive cancer in situ; T1=relatively small primary tumor that has not spread to surrounding tissues)
• Known Human immunodeficiency virus (HIV) seropositivity
• Known active or chronic Hepatitis B or Hepatitis C infection
• Known glucuronidation deficiency (Gilbert's syndrome)
• Any other severe concomitant disease or disorder, which could influence patient's ability to participate in the clinical trial and his/her safety during the trial or interfere with interpretation of results, e.g., severe hepatic, renal, pulmonary, cardiovascular, metabolic or psychiatric disorders

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Ipsen: collaborator

Study Sites (1)

The University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Study Officials

• Lei Zheng, MD, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Zheng, MD, PhD

CONTACT

(210) 450-1406; zhengl@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional, open-label, non-randomized, single-arm clinical trial with 2 cohorts of participants

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 14, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)