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

Guo ShiWei

Status: Completed

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

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

Study type: Observational

Funder types: Other

Identifiers

NCT07329920

Changhai Mesenchymal CTC R1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 4 patient groups

none treatment group

upfront surgery group

Treatment:

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

neoadjuvant/conversion therapy without surgery group

neoadjuvant/conversion therapy with surgery group

Treatment:

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