Surgical Resection after Chemotherapy for the Treatment of Pulmonary or Hepatic Oligometastatic Pancreatic Cancer

Inclusion Criteria

• PRE-SCREENING ENROLLMENT: Histologically confirmed diagnosis of treatment-naïve limited hepatic or pulmonary metastatic adenocarcinoma of the pancreas
• PRE-SCREENING ENROLLMENT: 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 University of Texas Health Science Center at San Antonio (UTHSA) radiologist * Definition of limited hepatic metastasis: 1 to 5 metastases in CT/MRI which are potentially resectable or treatable by ablative procedures ** Note 1: Patients also fulfil this inclusion criterion if a hepatic metastasis was partly or entirely removed as part of the diagnosis and is thus not detectable by CT/MRI ** Note 2: If more than 5 metastases are unexpectedly detected during surgery, it is not a violation of this inclusion criterion if the excess metastases had not been detectable by CT/MRI scan at screening * 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
• PRE-SCREENING ENROLLMENT: Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• PRE-SCREENING ENROLLMENT: Being a candidate for the chemotherapy with NALIRIFOX
• PRE-SCREENING ENROLLMENT: Patients ≥ 18 years at the time of signing the informed consent
• PRE-SCREENING ENROLLMENT: Patient’s written informed consent prior to any trial-specific procedure
• PRE-SCREENING ENROLLMENT: Patient’s legal capacity to consent to participation in the clinical trial
• STUDY ENTRY ENROLLMENT AT THE PRE-SURGERY PHASE: ECOG performance status 0-1
• STUDY ENTRY ENROLLMENT AT THE PRE-SURGERY PHASE: Received NALIRIFOX or its modified form with dose/schedule modifications. Switching to gemcitabine/nab-paclitaxel, fluorouracil/irinotecan/leucovorin calcium/oxaliplatin (FOLFIRINOX), fluorouracil (5FU)/liposomal irinotecan, fluorouracil/leucovorin calcium/irinotecan (FOLFIRI), fluorouracil/leucovorin calcium/oxaliplatin (FOLFOX), 5FU or capecitabine due to intolerability of NALIRIFOX is permitted
• STUDY ENTRY ENROLLMENT AT THE PRE-SURGERY PHASE: Radiographical evidence of disease response or stable disease with cancer antigen 19-9 (CA19-9) decrease > 20% from the baseline or CA19-9 that is not detectable
• STUDY ENTRY ENROLLMENT AT THE PRE-SURGERY PHASE: Patients ≥ 18 years at the time of signing the informed consent
• STUDY ENTRY ENROLLMENT AT THE PRE-SURGERY PHASE: Patient's written informed consent prior to any trial-specific procedure
• STUDY ENTRY ENROLLMENT AT THE PRE-SURGERY PHASE: Patient’s legal capacity to consent to participation in the clinical trial

Exclusion Criteria

• PRE-SCREENING ENROLLMENT: Acinar cell carcinoma and/or neuroendocrine carcinoma of the pancreas
• PRE-SCREENING ENROLLMENT: Symptomatic clinically significant ascites
• PRE-SCREENING ENROLLMENT: Evidence of any distant metastases other than limited hepatic or pulmonary metastasis as defined
• PRE-SCREENING ENROLLMENT: Evidence of simultaneous pulmonary and hepatic metastases
• PRE-SCREENING ENROLLMENT: 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 NALIFIRNOX has been given
• PRE-SCREENING ENROLLMENT: 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)
• PRE-SCREENING ENROLLMENT: Known HIV seropositivity
• PRE-SCREENING ENROLLMENT: Known active or chronic hepatitis B or hepatitis C infection
• PRE-SCREENING ENROLLMENT: 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
• STUDY ENTRY ENROLLMENT AT THE PRE-SURGERY PHASE: Symptomatic clinically significant ascites
• STUDY ENTRY ENROLLMENT AT THE PRE-SURGERY PHASE: Evidence of any distant metastases other than limited hepatic or pulmonary metastasis as defined
• STUDY ENTRY ENROLLMENT AT THE PRE-SURGERY PHASE: Evidence of simultaneous pulmonary and hepatic metastases
• STUDY ENTRY ENROLLMENT AT THE PRE-SURGERY PHASE: 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)
• STUDY ENTRY ENROLLMENT AT THE PRE-SURGERY PHASE: Pregnant or breast-feeding female
• STUDY ENTRY ENROLLMENT AT THE PRE-SURGERY PHASE: Radiographic evidence of severe portal hypertension
• STUDY ENTRY ENROLLMENT AT THE PRE-SURGERY PHASE: Liver cirrhosis ≥ Child Pugh B
• STUDY ENTRY ENROLLMENT AT THE PRE-SURGERY PHASE: Known HIV seropositivity
• STUDY ENTRY ENROLLMENT AT THE PRE-SURGERY PHASE: Known active or chronic hepatitis B or hepatitis C infection
• STUDY ENTRY ENROLLMENT AT THE PRE-SURGERY PHASE: 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)
• STUDY ENTRY ENROLLMENT AT THE PRE-SURGERY PHASE: 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
• STUDY ENTRY ENROLLMENT AT THE PRE-SURGERY PHASE: 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
• STUDY ENTRY ENROLLMENT AT THE PRE-SURGERY PHASE: Radiographical evidence of disease progression