Adenocarcinoma of the PancreasPHOLIPANCNCT07340151
Resection/Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma
A study testing Surgical resection in people with Adenocarcinoma of the Pancreas, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adenocarcinoma of the Pancreas
- What is being tested?
- Surgical resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- 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 scan at screening.
- 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.
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- 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.
Who cannot join
- 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 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
Lei Zheng, MD, 210-450-1406, zheng1@uthscsa.edu
About this study
Official title: Surgical Resection of Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma (PHOLIPANC) Following Pre-operative Liposomal Irinotecan Combined With Oxaliplatin and 5-Fluoracil/Folinic Acid (NALIRIFOX): A Phase II Open-Label Single Arm Trial
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).
Read more
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.
Read the detailed description
This is an interventional, open-label, non-randomized, single-arm clinical trial with 2 cohorts. Patients who have hepatic or pulmonary oligometastatic adenocarcinoma of the pancreas and who receive neoadjuvant Liposomal Irinotecan Combined with Oxaliplatin and 5-Fluoracil/Folinic Acid (NALIRIFOX) chemotherapy pre-operatively are eligible. In patients with progressive disease during or after the first four cycles, patients will become ineligible. 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 will receive 4 more cycles of neoadjuvant chemotherapy as per standard of care. 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. If the primary tumor is deemed unresectable by the surgeon during exploratory laparotomy, these patients may receive 4 more cycles of adjuvant chemotherapy as per standard of care 2-4 weeks after the exploratory laparotomy.
- Conditions
- Adenocarcinoma of the Pancreas
- Being tested
- Surgical resection
- Keywords
- Oligometastatic disease, Hepatic oligometastatic adenocarcinoma of the pancreas, Pulmonary oligometastatic adenocarcinoma of the pancreas, Surgical resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical resectionProcedure or surgery
Also called R0/R1 resection
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
| Study group | Role | What they receive |
|---|---|---|
| Lung Oligometastatic Cohort | Active comparator | Participants who have pulmonary oligometastatic pancreatic tumor Receives: Procedure: Surgical resection |
| Liver Oligometastatic Cohort | Active comparator | Participants who have hepatic oligometastatic pancreatic tumor Receives: Procedure: Surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of R0/R1 resection
Assessed by tumor imaging
Measured: Prior to surgery to 4-12 weeks after surgery
Secondary outcomes (6)
Safety of surgical resection of synchronous pulmonary or hepatic oligometastatic ductal adenocarcinoma
Surgical complications will be defined based on Clavien-Dindo classification and will be monitored continuously. The monitoring rule will focus on Grade IIIa surgical complication or above deemed related to the chemotherapy regimen (liposomal irinotecan, oxaliplatin, 6-fluorouracil/folinic acid) which is beyond what may be expected for chemotherapy or resection without immunotherapy.
Measured: End of surgical procedure
European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-30)
The QLQ-C30 is composed of both multi-item scales and single-item measures including 5 functional scales, 3 symptom scales, a global health status / QoL scale, and six single items.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
A crucial Summary Score (0-100) combines 13 scales (excluding Global QoL \& Financial Impact), with higher scores indicating better overall quality of life. Scoring requires specific formulas from the official manual, with procedures for handling missing data and ensuring consistency across different scales, often involving reversing symptom scales for uniform interpretation.
Measured: 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)
Raw scores from the questionnaire items (e.g., 1=Not at all, 4=Very much) are linearly transformed to a 0-100 scale.
Higher score on a symptom scale = Worse symptoms/more problems (e.g., pancreatic pain).
Higher score on a functional scale = Better quality of life/functioning (e.g., planning activities)
Measured: Prior to surgery and 4-12 weeks after surgery
Progression-free survival (PFS)
Assessment of mortality of participant continuously post surgery until study end.
Measured: Up to 25 months after re-section of tumor
Recurrence-free survival (RFS)
Assessment of health status of participant continuously post surgery until study end.
Measured: Up to 25 months after re-section of tumor
Overall survival
Length of time participant survives post surgical re-section.
Measured: Up to 25 months after re-section of tumor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start2 Mar 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the PancreasStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, open-label, non-randomized, single-arm clinical trial with 2 cohorts of participants
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ipsen
- Responsible party
- Sponsor
- Investigators
- Lei Zheng, MD, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340151
- Sponsor's protocol ID
- CTMS# 25-0006
- Acronym
- PHOLIPANC
- Status last verified
- Apr 2026
- First submitted
- 22 Dec 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Resection of Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma (PHOLIPANC) Following Pre-operative Liposomal Irinotecan Combined With Oxaliplatin and 5-Fluoracil/Folinic Acid (NALIRIFOX): A Phase II Open-Label Single Arm Trial
- ClinicalTrials.gov ID
- NCT07340151
- Acronym / sponsor ID
- PHOLIPANC / CTMS# 25-0006
- Conditions
- Adenocarcinoma of the Pancreas
- Keywords
- Oligometastatic disease, Hepatic oligometastatic adenocarcinoma of the pancreas, Pulmonary oligometastatic adenocarcinoma of the pancreas, Surgical resection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Ipsen
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an interventional, open-label, non-randomized, single-arm clinical trial with 2 cohorts. Patients who have hepatic or pulmonary oligometastatic adenocarcinoma of the pancreas and who receive neoadjuvant Liposomal Irinotecan Combined with Oxaliplatin and 5-Fluoracil/Folinic Acid (NALIRIFOX) chemotherapy pre-operatively are eligible. In patients with progressive disease during or after the first four cycles, patients will become ineligible. 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 will receive 4 more cycles of neoadjuvant chemotherapy as per standard of care. 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. If the primary tumor is deemed unresectable by the surgeon during exploratory laparotomy, these patients may receive 4 more cycles of adjuvant chemotherapy as per standard of care 2-4 weeks after the exploratory laparotomy.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional, open-label, non-randomized, single-arm clinical trial with 2 cohorts of participants
| Arm | Type | Receives |
|---|---|---|
| Lung Oligometastatic Cohort | Active comparator | Procedure: Surgical resectionParticipants who have pulmonary oligometastatic pancreatic tumor |
| Liver Oligometastatic Cohort | Active comparator | Procedure: Surgical resectionParticipants who have hepatic oligometastatic pancreatic tumor |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- 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
Key exclusion criteria (10 listed)
- 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 NALIRIFOX or its modified form is allowed, unless more than 2 treatments of NALIRIFOX have been given.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical resectionAlso: R0/R1 resectionPatients 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 | Procedure or surgery | Liver Oligometastatic Cohort, Lung Oligometastatic Cohort |
Primary outcome
Efficacy of R0/R1 resection
Time frame: Prior to surgery to 4-12 weeks after surgery
Assessed by tumor imaging
6 secondary outcomes
Safety of surgical resection of synchronous pulmonary or hepatic oligometastatic ductal adenocarcinoma
Time frame: End of surgical procedure
European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-30)
Time frame: 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)
Time frame: Prior to surgery and 4-12 weeks after surgery
Progression-free survival (PFS)
Time frame: Up to 25 months after re-section of tumor
Recurrence-free survival (RFS)
Time frame: Up to 25 months after re-section of tumor
Overall survival
Time frame: Up to 25 months after re-section of tumor
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lei Zheng, MD, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical resection in people with Adenocarcinoma of the Pancreas, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei Zheng, MD, PhD ((210) 450-1406, zhengl@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of R0/R1 resection (time frame: Prior to surgery to 4-12 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.