Surgery for Liver Metastases From PDAC

Launched by LINKOEPING UNIVERSITY · Feb 26, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of surgery for patients with pancreatic cancer that has spread to the liver. The goal is to see if treating patients with limited liver metastases—either when the cancer first appears or after initial treatment—can lead to better outcomes, such as improved survival rates. Before any surgical treatment, participants will receive chemotherapy to ensure their tumors respond well, which is a sign of more favorable tumor behavior. This study aims to gather valuable data about how to manage pancreatic cancer that has spread and to improve understanding of the biology behind liver metastases.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with pancreatic cancer that has spread to the liver, with a limited number of liver tumors that can be surgically removed or treated. Patients will need to have a good overall health status, as indicated by specific measures, and they should be able to understand the information given to them about the study. Throughout the trial, participants can expect to receive close monitoring and care, helping researchers learn more about how to effectively treat this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Confirmed PDAC with synchronous or metachronous dissemination isolated in the liver (primary cohort) or other dissemination as described in chapter 7.1. where the local tumour board find indication for curative treatment attempt.
• • The confirmation of PDAC before chemotherapy is not regulated by the protocol but EUS guided biopsies directed to the primary tumour or a site of recurrence/dissemination is recommended whereas a percutaneous approach towards liver lesion(s) can be an alternative diagnostic approach; radiology and elevated serum tumor markers may guide diagnosis in exceptional cases, for which, e.g., pathological sampling fails.
• • Metastases are defined as synchronous when liver tumors are detected simultaneously with the primary tumor or within the first 6 months thereafter. All other tumors are regarded as metachronous metastases or locally recurrent disease (when applicable).
• • The same definition applies to localized lesions detected intra- as well as extra-abdominally.
• • Patients treated due to the radiological appearance and or elevated CA-19.9 levels despite negative biopsies are accepted for inclusion into the study
• To be included in "Limited liver desease":
• • Up to 4 liver metastases treatable with liver resections (without volume expansion of the future liver remnant)/thermal ablations/RFA/IRE (largest diameter \< 5 cm and for ablative techniques \< 2 cm).
• • Age 18 years or older ECOG 0-1 Any resectable (including borderline resectable, but without need for arterial reconstruction) (before or after neoadjuvant treatment) PDAC Patient can understand verbal and written information
• Exclusion Criteria:
• • Age less than 18 years ECOG \>2 Patient is not able to understand the verbal and written information Progression of tumor (RECIST 1.1) during or after chemotherapy Distant metastases outside the liver (applies only to the primary cohort) Other malignancy within 2 years, the prognosis of which may affect the evaluation of the therapeutic outcome.
• • Major non-pancreatic surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery Uncontrolled (bacterial or fungal) infections Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments Uncontrolled angina pectoris; cardiac failure or clinically significant arrhythmias Continuous use of immunosuppressive agents (Corticoids are allowed) Neuropathy \>grade 1 (CTCAE, v 5.0) Pregnancy or breast feeding Patients (M/F) with reproductive potential not implementing adequate contraceptive measures Pre-defined need for arterial reconstruction to resect primary tumor