Multimodal Managements for Metastatic Pancreatic Cancer.

Pancreatic ductal adenocarcinoma (PDAC) remains a challenging malignancy, with over 300,000 patients diagnosed annually worldwide. Patients with metastatic pancreatic cancer (MPC) are generally not considered appropriate for operative management because it would not improve their prognosis.

Developments in modern surgery and systemic treatment over the past decade have substantially improved the oncological outcomes for patients with PDAC. The prognosis can be further improved by using novel combined regimens. Systemic treatment is advantageous as it allows biological selection of patients and control of systemic lesions in patients with PDAC with only hepatic metastases (Hep-MPC), which may increase the likelihood of radical tumor resection and improved survival. Therefore, there is a strong need to reassess the value of surgery in Hep-MPC.

Locoregional liver-directed treatments (LLDTs) are safe and efficient methodologies and have thus become the standard of care for patients with metastatic colorectal cancer (MCC) with liver-only or liver-dominant metastases. LLDT therapies include local liver resection, radiofrequency ablation (RFA), hepatic artery infusion pump chemotherapy (HAIP), stereotactic body radiation therapy (SBRT), and selective internal radiation therapy with yttrium-90 embolization (Y90). These therapies have been reported to influence the overall survival (OS), progression-free survival (PFS), and conversion to resection in patients with metastatic colorectal cancer. However, the data on the survival outcomes of conversion surgery and the clinical application of LLDT in Hep-MPC are sparse. Therefore, it remains unclear what types of treatment, based on the survival benefit, might actually be the optimal approach for Hep-MPC after effective systemic treatment.

The present study aims to clarify the selection criteria of conversion surgery for Hep-MPC and explore the prognostic significance for its multimodal management, including surgical resection and/or LLDT.

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Key information

Conditions

Metastatic Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The first affiliated hospital, Zhejiang university school of medicine

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients aged ≥18 years (at diagnosis).
Cytologically or histologically confirmed pancreatic adenocarcinoma.
Synchronous liver metastatic disease (at diagnosis).
No evidence of extrahepatic metastases (at diagnosis.)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
Eligible for multimodal treatment.

Exclusion criteria

Multi-organ metastatic pancreatic cancer.
Contraindications to surgical resection or systemic treatment.
Inability to participate in follow-up assessments.
History of other malignancies.
Refusal of treatment.

Treatment and study plan

Multimodal treatment

Other

Surgical resection, locoregional liver-directed treatments and continuous systemic treatment in patients with liver metastatic pancreatic cancer

Primary outcomes

Overall survival

Time frame: From the date of treatment initiation to the date of death or the last date of follow-up (up to 60 months)

Calculated from the date of treatment initiation to the date of death or the last date of follow-up

Secondary outcomes

Progression free survival

Time frame: From the date of treatment initiation to the date of disease progression or death, whichever occurred first (up to 60 months).

The duration between the date of treatment initiation and disease progression or death, whichever occurred first.

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

Analysis of the Current Situation of Diagnosis and Treatment of Pancreatic Cancer: Multimodal Managements for Metastatic Pancreatic Cancer

Important dates

Study start: 2019
Primary completion: 2023
Study completion: 2025
First posted: May 13, 2025
Registry last updated: May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed