NCT06690528 Conversion Surgery Vs. Palliative Care in Pancreatic Cancer Oligometastatic to the Liver
| NCT ID | NCT06690528 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Azienda Ospedaliera di Padova |
| Condition | Pancreatic Cancer Metastatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2024-11-06 |
| Primary Completion | 2028-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 56 participants in total. It began in 2024-11-06 with a primary completion date of 2028-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study investigates the impact of surgical resection compared to palliative care in patients with oligometastatic pancreatic cancer limited to the liver. Specifically, it examines whether surgery after stable disease or response to chemotherapy can improve survival and quality of life. The international, multicenter randomized trial will recruit 56 patients, assigning them to either surgical resection (including tumor and liver metastases) or ongoing palliative care with chemotherapy. Stratification by performance status, tumor markers, and tumor location will ensure balanced study groups. Outcome assessments, conducted over a minimum two-year follow-up, include clinical evaluations, imaging, and quality-of-life metric
Eligibility Criteria
Inclusion Criteria: * Adult patients aged ≥18 years and ≤75 years (at diagnosis). * Cytologically or histologically confirmed pancreatic adenocarcinoma either resectable or borderline resectable (at diagnosis) according to National Comprehensive Cancer Network (NCCN)4 (see section 5). * Synchronous oligometastatic disease (at diagnosis), defined as a limited number of radiologically documented liver metastases (up to 3 lesions). * No evidence of extrahepatic metastases (at diagnosis.) * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 (at enrollment) * Partial response or stable disease after completion of first-line chemotherapy, as determined by RECIST 1.1 criteria21 (modified to exclude any % of increase in the sum of diameters of target lesions) (at enrollment). * Decreasing or stable (defined as ≤20% increase) serum CA19-9 level after chemotherapy (at enrollment). * Liver metastases considered resectable (see section 5) or alternatively treatable by needle ablation/microwave once no larger than 20 mm (at enrollment). Exclusion Criteria: * Locally advanced pancreatic cancer according to NCCN4. * Unresectable liver disease (according to multidisciplinary discussion). * Involvement of other organs. * Presence of significant comorbidities precluding surgery. * Pregnancy. * Contraindications to surgical resection. * Prior surgical resection of the primary tumor or liver metastases. * Evidence of extrahepatic metastases. * Inability to provide informed consent or participate in follow-up assessments. * Disease progression as determined by RECIST 1.1 criteria21 (modified to include any % of increase in the sum of diameters of target lesions) after chemotherapy. * Serum CA19-9 level increase \>20% after chemotherapy. Note: Additional specific exclusion criteria may be defined at each participating center based on their institutional guidelines and patient population.
Contact & Investigator
Giovanni Marchegiani, Medical Doctor, PhD, Professor
✉ giovanni.marchegiani@unipd.it📞 +390498212259
Giovanni Marchegiani, MD, PhD, Professor
STUDY CHAIR
University of Padova
Frequently Asked Questions
Who can join the NCT06690528 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pancreatic Cancer Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06690528 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06690528 currently recruiting?
Yes, NCT06690528 is actively recruiting participants. Contact the research team at giovanni.marchegiani@unipd.it for enrollment information.
Where is the NCT06690528 trial being conducted?
This trial is being conducted at Padova, Italy.
Who is sponsoring the NCT06690528 clinical trial?
NCT06690528 is sponsored by Azienda Ospedaliera di Padova. The principal investigator is Giovanni Marchegiani, MD, PhD, Professor at University of Padova. The trial plans to enroll 56 participants.
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