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

January 9, 2026 updated by: Guo ShiWei

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200433
        • Department of Hepatobiliary and Pancreatic Surgery, First Affiliated Hospital of Naval Medical UniversityUniversity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
none treatment group
upfront surgery group
Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines
Retrospective studies do not require intervention measures.
neoadjuvant/conversion therapy without surgery group
neoadjuvant/conversion therapy with surgery group
Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines
Retrospective studies do not require intervention measures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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 Outcome Measures

Outcome Measure
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guo ShiWei

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2018

Primary Completion (Actual)

September 15, 2021

Study Completion (Actual)

October 1, 2025

Study Registration Dates

First Submitted

December 27, 2025

First Submitted That Met QC Criteria

December 27, 2025

First Posted (Estimated)

January 9, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Changhai Mesenchymal CTC R1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

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