Surgical Resection Of Synchronous Pulmonary Or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma

Study Overview

Surgical Resection of Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma

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.

In this clinical trial the investigators will enroll subjects with hepatic or pulmonary oligometastatic pancreatic ductal adenocarcinoma and perform a synchronous surgical resection. In patients with progressive disease during or after the first four cycles of neoadjuvant chemotherapy, those patients will not be eligible for study enrollment. Patients with tumor response or stable disease after the first 4-cycles but a non-resectable primary tumor according to the evaluation of an interdisciplinary tumor board must receive 4 more cycles of neoadjuvant chemotherapy before being evaluated for eligibility for the Study Entry Screening. Patients with hepatic metastasis with tumor response or stable disease and a resectable primary tumor after the first 4 cycles 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 patients 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. 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. 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.

Pancreatic Ductal Adenocarcinoma
Oligometastatic Disease

PROCEDURE: Surgery

J23143
IRB00414679 (OTHER Identifier) (OTHER: JHM IRB)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-11-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-06-16
First Submitted that Met QC Criteria 2023-11-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-06-19
First Posted (ACTUAL) 2023-11-08	Results First Posted N/A	Last Verified 2025-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Treatment arm liver/lung oligometastasis 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. Patient	PROCEDURE: Surgery 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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Treatment arm liver/lung oligometastasis

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. Patient

PROCEDURE: Surgery

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

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
Perioperative morbidity and mortality as assessed by the Common terminology criteria for adverse events	The safety analysis includes type, incidence, and severity of adverse events (severity according to Common terminology criteria for adverse events version 5.0).	48 months
Medium Overall Survival (OS) and Disease Free Survival	Kaplan-Meier survival curves will be constructed to summarize disease free survival and overall survival, respectively.	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)	Questions 1 to 28, a 4-point scale is used, ranging from 1 ("Not at all") to 4 ("Very much"), with lower scores indicating a more positive outcome. Questions 29 and 30 employ a 7-point scale, with scores ranging from 1 ("Very poor") to 7 ("Excellent"), where higher scores signify a better outcome	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)	European Organisation for Research and Treatment of Cancer in pancreatic cancer includes 26 questions with two subscales: functioning scales (4 questions),and symptom scales (22 questions). The functional scale, the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life. All scores are scaled to range from 0-100.	48 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jin He, MD, PhD

Phone Number: +1(410)614-7551

Email: jhe11@jhmi.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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 2. Exclusion Criteria at the Pre-Screening Enrollment

Acinar cell carcinoma and/or neuroendocrine carcinoma of the pancreas
Symptomatic clinically significant ascites
Evidence of any distant metastases other than limited hepatic or pulmonary metastasis as defined in inclusion criterion 1.
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
Evidence of any distant metastases other than limited hepatic or pulmonary metastasis as defined in inclusion criterion 1.
Evidence of simultaneous pulmonary and hepatic metastases
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)
Pregnant or breast-feeding female
Radiographic evidence of severe portal hypertension
Liver cirrhosis ≥ Child Pugh B
Known HIV seropositivity
Active or chronic Hepatitis B or Hepatitis C infection
Clinically significant cardiovascular or vascular disease or disorder ≤6 months before enrolment into the clinical trial (e.g., myocardial infarction, unstable angina pectoris, chronic heart failure New York Heart Association (NYHA) ≥ Grade 2, uncontrolled arrhythmia, cerebral infarction)
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.
Hepatic metastasis that are only amenable to ablation. However, if liver lesions are found intraoperatively and subsequently ablated and if the pancreatic surgery is distal pancreatectomy, the patients would still be considered evaluable. Ablation of liver lesions during the pancreatoduodenectomy is not allowed.
Radiographical evidence of disease progression.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Jin He, MD, PhD, Johns Hopkins University

Publications

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General Publications

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Clinical Trial Record