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NCT Number: NCT07226154

Prediction of Neoadjuvant Chemotherapy Response in Pancreatic Cancer

This study aims to develop and validate a predictive microRNA (miRNA) panel to assess the response to neoadjuvant chemotherapy (NACT) in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma (PDAC).

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Key information

Conditions

Pancreatic Ductal Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

City of Hope Medical Center

Duarte, California, 91016, United States

Location status: Recruiting

Location contact

Ajay Goel, PhD

CONTACT

[email protected]

626-218-3452

About this study

Pancreatic ductal adenocarcinoma (PDAC) remains one of the most lethal malignancies, with a five-year overall survival rate below 12%. Surgical resection combined with systemic chemotherapy offers the best chance for cure; however, only a subset of patients truly benefits from neoadjuvant chemotherapy (NACT). Currently, there are no validated biomarkers to predict response to NACT, making treatment selection largely empirical.

The PRECEPT study (PREdiction of Chemotherapy Effect in Pancreatic Cancer Treatment) aims to identify and validate microRNA (miRNA)-based biomarkers from pre-treatment plasma that can predict therapeutic response to neoadjuvant chemotherapy in patients with resectable or borderline resectable PDAC. Specifically, the study focuses on two standard regimens: FOLFIRINOX and gemcitabine plus nab-paclitaxel (GEM-NABP).

This is a retrospective, non-interventional, observational study using archived plasma samples collected before the initiation of NACT. Exosomal miRNA sequencing (small RNA-seq) has been performed to identify candidate predictive miRNAs. These candidates will be validated using quantitative reverse transcription PCR (qRT-PCR) in an independent patient cohort. The association between miRNA expression levels and pathologic response (CAP grade or tumor regression score) will be analyzed. Additionally, correlations with overall survival (OS) and recurrence-free survival (RFS) will be explored.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically confirmed pancreatic ductal adenocarcinoma (PDAC).
  • Underwent neoadjuvant chemotherapy (FOLFIRINOX or Gemcitabine/nab-paclitaxel).
  • Availability of pre-treatment plasma samples.
  • Underwent curative-intent resection (R0 or R1).

Exclusion criteria

  • Inadequate plasma samples or poor RNA quality for exosomal miRNA analysis.
  • Non-adenocarcinoma histology.
  • Presence of synchronous or multiple primary malignancies.
  • Receipt of chemotherapy regimens other than standard FOLFIRINOX or gemcitabine plus nab-paclitaxel (GEM-NABP).
  • Presence of active inflammatory or autoimmune diseases.

Treatment and study plan

Small RNA sequencing

Diagnostic Test

High-throughput small RNA sequencing performed on pre-treatment plasma samples from PDAC patients in the Discovery cohort to identify candidate microRNAs associated with neoadjuvant chemotherapy response. Sequencing data were analyzed to detect differentially expressed miRNAs between responder (CR + PR + SD) and non-responder (PD) groups.

PRECEPT assay (qRT-PCR validation)

Diagnostic Test

Quantitative reverse transcription PCR (qRT-PCR)-based validation assay performed on pre-treatment plasma samples in the Training and Validation cohorts. Candidate microRNAs identified in the Discovery cohort by small RNA sequencing were tested using the PRECEPT assay to develop and validate a predictive miRNA panel for neoadjuvant chemotherapy response.

Primary outcomes

  1. Pathological Response Rate

    Time frame: up to 1 year

    Proportion of patients achieving partial or complete pathologic response after neoadjuvant chemotherapy, as assessed using resected pancreatic cancer specimens.

Secondary outcomes

  1. Recurrence-Free Survival (RFS)

    Time frame: Up to 3 years after surgery

    Time from date of surgical resection to first documented recurrence or death from any cause, whichever occurs first.

  2. Overall Survival (OS)

    Time frame: Up to 5 years after surgery

    Time from date of surgical resection to date of death from any cause. Patients alive at last follow-up will be censored.

  3. Radiologic Response Rate

    Time frame: up to 1 year

    Proportion of patients achieving partial or complete radiologic response during neoadjuvant chemotherapy, as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 using contrast-enhanced CT or MRI scans.

Study contacts

Contact information is provided by the study sponsor or research team.

Ajay Goel, PhD

CONTACT

[email protected]

626-218-3452

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Registry information

Official study title

An Exosomal miRNA Based Predictive Model for Personalized Neoadjuvant Chemotherapy Selection in Pancreatic Ductal Adenocarcinoma

Acronym: PRECEPT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 10, 2025
Registry last updated
Nov 21, 2025

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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