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Trial Title:
Application of ctDNA in Evaluation of Neoadjuvant Chemotherapy Efficacy and Exploration of Chemoresistance Mechanisms in Pancreatic Cancer
NCT ID:
NCT05848154
Condition:
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
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
Pancreatic Neoplasms
Circulating tumor DNA
Neoadjuvant Therapy
Treatment Outcome
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
ctDNA detection
Description:
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
patients. WES and RNA-seq of samples from patients before and after treatment are
performed to reveal the mechanisms of drug resistance.
Arm group label:
ctDNA detection group
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Study pop:
Patients with non-metastatic pancreatic cancer. Evaluation of tumor resectability should
be made in consensus at multidisciplinary meetings/discussions, according to NCCN
guideline of pancreatic adenocarcinoma, Version 1.2022.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongshan Hospital
Address:
City:
Shanghai
Zip:
200000
Country:
China
Contact:
Last name:
Wen-Quan Wang, MD, PhD
Phone:
+86 21 31587861
Email:
wang.wenquan@zs-hospital.sh.cn
Investigator:
Last name:
Wen-hui Lou, MD, PhD
Email:
Principal Investigator
Start date:
June 1, 2023
Completion date:
January 31, 2026
Lead sponsor:
Agency:
Shanghai Zhongshan Hospital
Agency class:
Other
Collaborator:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Amoy Diagnostics Co., LTD
Agency class:
Other
Source:
Shanghai Zhongshan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05848154
