Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT06690528
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06690528
Study Brief:
Protocol Section:
NCT06690528