Mesenchymal CTC Ratio Dynamics Predicts Response and Survival in Pancreatic Ductal Adenocarcinoma With Neoadjuvant/Conversion Therapy

Guo ShiWei300 enrolled

Overview

The aim of this study was to evaluate the clinical utility of mesenchymal CTC ratio dynamics as a real-time biomarker for PDAC patients with neoadjuvant therapy.

In this study, the investigators generated the largest PDAC patient cohort for CTC detection to date, which revealed mesenchymal CTC ratio dynamics as a robust biomarker during neoadjuvant therapy. The mesenchymal CTC ratio varied significantly across resectability status of PDAC with the highest level in the metastatic cohort. Moreover, the mesenchymal CTC ratio dynamics could be used for real-time assessment of neoadjuvant therapy response, accurate postoperative relapse surveillance and reliable prognostication.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)Circulating Tumor Cells (CTCs)Neoadjuvant Therapy

Interventions

surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelinesPROCEDURE

Retrospective studies do not require intervention measures.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who underwent CTC detection at the time of PDAC diagnosis were collected from the prospective database. All patients were pathologically confirmed with PDAC by endoscopic ultrasound guided fine-needle aspiration or surgical resection specimens. According to therapeutic modalities, these patients were divided into four subgroups: none treatment group, upfront surgery group, neoadjuvant/conversion therapy without surgery group and neoadjuvant/conversion therapy with surgery group. All patients provided written informed consent to use their clinical data and samples. Exclusion Criteria: * Patients who could not tolerate neoadjuvant therapy or who had invasive intraductal papillary mucinous neoplasms, mucinous cystadenocarcinomas, or other non-pancreatic periampullary adenocarcinomas were excluded.

Locations (1)

Department of Hepatobiliary and Pancreatic Surgery, First Affiliated Hospital of Naval Medical UniversityUniversity

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Overall survival

Time frame: Overall survival (OS) was defined as the interval from the date of diagnosis to the date of patient death or the last follow-up visit 1 month after surgery.

Secondary Outcomes

Recurrence-free survival

Time frame: Recurrence-free survival (RFS) was defined as the time interval from the date of diagnosis to the date of local or regional recurrence, distant metastases, death or the last follow-up visit 1 month after surgery.

Data from ClinicalTrials.gov

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