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Completed

NCT Number: NCT07329920

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Shanghai, Shanghai Municipality, 200433, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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

Procedure

Retrospective studies do not require intervention measures.

Primary outcomes

  1. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

Guo ShiWei

Other

Registry information

Official study title

Mesenchymal CTC Ratio Dynamics Predicts Response and Survival in Pancreatic Ductal Adenocarcinoma With Neoadjuvant/Conversion Therapy: a Large Single-center Retrospective Cohort Study

Important dates

Study start
2018
Primary completion
2021
Study completion
2025
First posted
Jan 9, 2026
Registry last updated
Jan 12, 2026

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.

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