Clinical trialNATerminated
Surgical Resection of Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma
Surgical Resection of Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma (PHOLIPANC): A Phase II Single Arm Trial
- Outcome
- Stopped earlyStudy team no longer available to support recruitment and enrollment activities. (Enrollment)
- Phase
- NA
- Status
- Terminated
- Study type
- Interventional
- Start
- 21 May 2024
- Expected end
- 8 April 2026
- Enrollment
- 5 participants
- Sites
- 1
- Primary outcomes
- 2-year overall survival will be measured for the evaluable liver and Lung oligometastasis patient cohorts, respectively, and compare to historical controls.; Compare the Intrametastasis effector T cell infiltration
- Sponsor
- Other
- Results posted
- No
- Last update
- 15 April 2026
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
Ask this document
Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.
Try
Source text
Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
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.