Application Of CtDNA In Evaluation Of Neoadjuvant Chemotherapy Efficacy And Exploration Of Chemoresistance Mechanisms In Pancreatic Cancer

Study Overview

Application of ctDNA in Evaluation of Neoadjuvant Chemotherapy Efficacy and Exploration of Chemoresistance Mechanisms in Pancreatic Cancer

The purpose of this study is to evaluate the value of ctDNA detection in the assessment of response rate to neoadjuvant chemotherapy in pancreatic cancer and to explore the correlation between ctDNA clearance and prognosis at different time points. Meanwhile, whole exome sequencing (WES) and RNA Sequencing (RNA-seq) of samples of responders and non-responders to neoadjuvant chemotherapy before and after treatment are performed to explore the mechanisms of drug resistance and provide guidance for clinical decision making.

Pancreatic cancer is highly malignant with poor prognosis, and the overall 5-year survival rate is only about 9%. The value of neoadjuvant therapy in pancreatic cancer has been demonstrated by many studies, and a scientific and accurate evaluation of the efficacy of neoadjuvant therapy is crucial to its implementation and achieving the best outcomes. Circulating tumor DNA (ctDNA) analysis provides a non-invasive way to repeatedly assess the genomic profile of tumor. With improvements in detection techniques providing higher levels of sensitivity, ctDNA analysis is rapidly being accepted as a reliable tool in oncology. The purpose of this study is to evaluate the value of ctDNA detection in the assessment of response rate to neoadjuvant chemotherapy in pancreatic cancer and to explore the correlation between ctDNA clearance and prognosis at different time points. Meanwhile, whole exome sequencing (WES) and RNA Sequencing (RNA-seq) of samples of responders and non-responders to neoadjuvant chemotherapy before and after treatment are performed to explore the mechanisms of drug resistance and provide guidance for clinical decision making.

Patients With Non-metastatic Pancreatic Cancer
Evaluation of Tumor Resectability Shall be Made in Consensus at Multidisciplinary Meetings, According to NCCN Guideline Version 1.2022 Pancreatic Adenocarcinoma

DIAGNOSTIC_TEST: ctDNA detection

ZSPAC-07

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-02-12	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-05-14
First Submitted that Met QC Criteria 2023-04-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-05-16
First Posted (ACTUAL) 2023-05-08	Results First Posted N/A	Last Verified 2023-05

Study Plan

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

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: ctDNA detection group ctDNA detection, WES and RNA-seq will be performed on blood samples of all patients in this group.	DIAGNOSTIC_TEST: ctDNA detection Blood samples are collected from patients at different time points during the monitoring process before treatment, after treatment, after surgery, and after adjuvant therapy/chemotherapy. ctDNA detection is performed on blood samples of all enrolled patie

Participant Group/Arm

Intervention/Treatment

: ctDNA detection group

ctDNA detection, WES and RNA-seq will be performed on blood samples of all patients in this group.

DIAGNOSTIC_TEST: ctDNA detection

Blood samples are collected from patients at different time points during the monitoring process before treatment, after treatment, after surgery, and after adjuvant therapy/chemotherapy. ctDNA detection is performed on blood samples of all enrolled patie

Primary Outcome Measures	Measure Description	Time Frame
Objective response rate (ORR) of neoadjuvant therapy in patients with non-metastatic pancreatic cancer	Pre-treatment ctDNA detection and mutation characterization in blood are used to evaluate objective response rate (ORR) of neoadjuvant therapy in patients with non-metastatic pancreatic cancer.	Up to 24 months

Secondary Outcome Measures	Measure Description	Time Frame
Rate of adverse reactions	ctDNA detection is performed to evaluate the rate of adverse reactions to neoadjuvant therapy in patients with non-metastatic pancreatic cancer.	One week during therapy and 3 months thereafter up to 24 months.
The correlation between detection of blood ctDNA and mutation characteristics before treatment and the rate of adverse reactions	ctDNA detection is performed to analyze the correlation between detection of blood ctDNA and mutation characteristics before treatment and the rate of adverse reactions.	One week during therapy and 3 months thereafter up to 24 months.
The correlation between postoperative ctDNA in blood and clearance of ctDNA after adjuvant therapy and overall survival (OS) in patients with operable pancreatic cancer	Correlation between postoperative ctDNA in blood and clearance of ctDNA after adjuvant therapy and overall survival (OS) in patients with operable pancreatic cancer.	One week during therapy and 3 months thereafter up to 48 months.
The recurrence of pancreatic cancer	Blood ctDNA after treatment is used to monitor the recurrence of pancreatic cancer.	One week during therapy and 3 months thereafter up to 24 months.
The timeliness and accuracy of ctDNA with CA19-9 and medical imaging in the detection of disease recurrence	Blood ctDNA after treatment is used to compare the timeliness and accuracy of ctDNA with CA19-9 and medical imaging in the detection of disease recurrence.	Up to 24 months.
The mechanisms of drug resistance to neoadjuvant chemotherapy	WES and RNA-seq of tissue samples of pancreatic cancer patients before and after treatment are performed to explore the mechanisms of drug resistance to neoadjuvant chemotherapy.	One week during therapy and 3 months thereafter up to 24 months.

Contacts and Locations

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

Study Contact

Name: Wen-Quan Wang, MD, PhD

Phone Number: +86 21 31587861

Email: wang.wenquan@zs-hospital.sh.cn

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Newly diagnosed patients with non-metastatic pancreatic cancer;
The pathological features were identified as pancreatic ductal carcinoma;
Patients with clinical risk factors including significantly elevated CA19-9 levels at diagnosis, large primary tumor volume, large regional lymph node diameter, significant weight loss, and extreme pain;
Patients accept neoadjuvant chemotherapy voluntarily with the regimen of modified FOLFIRINOX, and disease evaluation should be conducted every two courses, surgery should be performed without delay if resection criteria have been met, and at least two courses of chemotherapy should be completed;
Age ≥18 years old;
No other tumor treatment within 4 weeks prior to enrollment;
Complete clinical data, including basic information, pathological information, treatment information;
The subjects voluntarily join the study and sign the informed consent with good compliance, and cooperate with the acquisition of tissue samples and regular blood samples.

Any other systemic antitumor therapy priorly;
Concomitant malignancies under treatment;
Patients with a history of allergy to relevant chemotherapy agents;
Failure to comply with the requirements of the visit plan;
Patients who may be absent from the visit period for 2 weeks or more during the treatment period;
The researchers determine that the subjects have other factors that could have caused the study to be discontinued.

Collaborators and Investigators

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

Fudan University
Amoy Diagnostics

Investigators

PRINCIPAL_INVESTIGATOR: Wen-hui Wen-hui, MD, PhD, Shanghai Zhongshan Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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