Surgical Resection of Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma

NCT06122480 | Terminated

• 2 other identifiers: J23143IRB00414679
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical Resection of Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma (PHOLIPANC). This is an interventional, open-label, non-randomised, single-arm phase II clinical trial. Eligible patients with hepatic or pulmonary oligometastatic adenocarcinoma of the pancreas must have received neoadjuvant FOLFIRINOX chemotherapy in cycles of 14 days, or other clinically indicated alternative. FOLFIRINOX is not a study treatment.

Conditions

Pancreatic Ductal Adenocarcinoma; Oligometastatic Disease

Keywords

Hepatic metastasis; Pulmonary metastasis; Oligometastasis; Surgical Resection

Outcome Measures

Primary Outcomes (2)

• 2-year overall survival will be measured for the evaluable liver and Lung oligometastasis patient cohorts, respectively, and compare to historical controls.

  Time-to-event data will be analyzed according to the Kaplan-Meier method (product-limit analysis). Patients who are not known to have had an event by the time of the analyses will be censored based on the last recorded date the patient was known to be event-free.

  48 months

• Compare the Intrametastasis effector T cell infiltration

  The liver oligometastasis cohort and the lung oligometastasis cohort will be compared in terms of intra-tumoral CD8+ T cells.

  48 months

Secondary Outcomes (4)

• Perioperative morbidity and mortality as assessed by the Common terminology criteria for adverse events

  48 months

• Medium Overall Survival (OS) and Disease Free Survival

  48 months

• Health-related quality of life will be assessed by the European organization for research and treatment of cancer quality of life questionnaire (EORTC QLQ-C30)

  48 months

• Health-related quality of life as assessed by the European Organisation for Research and Treatment of Cancer in Pancreatic Cancer (EORTC QLQ-PAN26)

  48 months

Study Arms (1)

Treatment arm liver/lung oligometastasis

EXPERIMENTAL

Eligible patients with hepatic or pulmonary oligometastatic adenocarcinoma of the pancreas must have received neoadjuvant FOLFIRINOX chemotherapy in cycles of 14 days, or other clinically indicated alternative. FOLFIRINOX is not a study treatment. Patients with pulmonary metastasis with tumor response or stable disease and a resectable primary tumor after the first 4 cycles can undergo resection of the primary tumor followed by resection of pulmonary metastases or vice versa, if feasible.Patients with hepatic metastasis with tumor response or stable disease and a resectable primary tumor can undergo explorative laparotomy and synchronous resection of the tumor and hepatic metastases, if feasible. In patients who undergo exploratory laparotomy and are deemed to have unresectable disease by the surgeon, the patient may receive 4 more cycles of neoadjuvant chemotherapy 2-4 week after surgery, before the patient will be re-evaluated for the eligibility for the Study Entry Screening.

Procedure: Surgery

Interventions

Surgery PROCEDURE

All eligible patients with hepatic metastasis will undergo exploratory laparotomy surgery and synchronous resection of the tumor and hepatic metastases, if feasible according to the surgeon, 2-6 weeks after the last neoadjuvant chemotherapy treatment. All eligible patients with pulmonary metastasis will undergo resection of the primary tumor followed by resection of pulmonary metastases or vice versa, if feasible

Treatment arm liver/lung oligometastasis

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: 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 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 Johns Hopkins Medicine radiologist.
• Measurable disease according to RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Being a candidate for the chemotherapy with FOLFIRINOX or modified FOLFIRINOX
• Patients ≥18 years at the time of signing the informed consent
• 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 FOLFIRINOX or modified FOLFIRINOX (mFOLFIRINOX) is allowed, unless more than 2 treatments of FOLFIRINOX or mFOLFIRINOX has 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)
• Known HIV seropositivity
• Known active or chronic Hepatitis B or Hepatitis C infection
• 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
• ECOG performance status 0-1
• Received FOLFIRINOX, modified FOLFIRINOX or the further modified forms including FOLFIRI, FOLFOX, 5FU or capecitabine. Liposomal irinotecan is permitted. Switching to gemcitabine/nal-paclitaxel due to intolerability of FOLFIRINOX is also permitted.
• Radiographical evidence of disease response or stable disease with CA19-9 decrease \> 20% from the baseline or CA19-9 that is not detectable
• Patients ≥18 years at the time of signing the informed consent
• Patient's written informed consent prior to any trial-specific procedure
• Patient's legal capacity to consent to participation in the clinical trial
• Symptomatic clinically significant ascites

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Jin He, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 8, 2023
• Study Start: May 21, 2024
• Primary Completion: February 10, 2026
• Study Completion: April 8, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)