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临床试验/NCT06967233
NCT06967233已完成不适用

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

Zhejiang University1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2019年6月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
360
试验地点
1
主要终点
Overall survival

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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-
  • Eligible for multimodal treatment.

排除标准

  • 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.

结局指标

主要结局

Overall survival

时间窗: 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

次要结局

  • Progression free survival(From the date of treatment initiation to the date of disease progression or death, whichever occurred first (up to 60 months).)

研究者

发起方
Zhejiang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

TingBo Liang

Professor

Zhejiang University

研究点 (1)

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