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New treatment option for Pancreatic Cancer Metastatic
Official title Conversion Surgery Vs. Palliative Care in Pancreatic Cancer Oligometastatic to the Liver
ClinicalTrials.gov ID: NCT06690528
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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)
You likely can't join if
- 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.
See the full eligibility 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Padova, Italy, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Padova, Italy, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.