Not yet recruitingNCT05848154Updated May 16, 2023

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

An observational study in Patients With Non-metastatic Pancreatic Cancer and Evaluation of Tumor Resectability Shall be Made in Consensus at Multidisciplinary Meetings, According to NCCN Guideline Version 1.2022 Pancreatic Adenocarcinoma, sponsored by Shanghai Zhongshan Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-05-16.

Sponsored by Shanghai Zhongshan Hospital · Observational

From the registry’s dates

Primary completion was expected by Jan 2026, 8 months ago, but the record still lists the study as not yet recruiting.

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 92
Ages: 18 Years to 75 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

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

Browse trials for

Pancreatic Neoplasms 3,235

Keywords

Pancreatic Neoplasms
Circulating tumor DNA
Neoadjuvant Therapy
Treatment Outcome

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's planned enrollment of 92 is below the median of 200 across 620 observational studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

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.

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

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 92 participants (estimated)
Patient registry: No

Groups and cohorts

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

Interventions

Diagnostic testctDNA 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 patients. WES and RNA-seq of samples from patients before and after treatment are performed to reveal the mechanisms of drug resistance.

What researchers measure

Primary outcomes

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.
Time frame: Up to 24 months

Secondary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: One week during therapy and 3 months thereafter up to 24 months.

Study locations

1 site

Zhongshan Hospital
Shanghai, Shanghai 200000, China
- Wen-Quan Wang, MD, PhD · Contact · wang.wenquan@zs-hospital.sh.cn · +86 21 31587861
- Wen-hui Lou, MD, PhD · Principal investigator

References and documents

Individual participant data

Plan to share: No — The IPD will not be shared with other researchers in order to protect patients' privacy.

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05848154
Lead sponsor: Shanghai Zhongshan Hospital
Collaborators: Fudan University, Amoy Diagnostics
Responsible party: Sponsor
First posted: May 8, 2023
Start date: Jun 1, 2023 (estimated)
Primary completion: Jan 31, 2026 (estimated)
Completion: Jan 31, 2026 (estimated)
Last update: May 16, 2023

Study contacts

Wen-Quan Wang, MD, PhD

Contact

wang.wenquan@zs-hospital.sh.cn

+86 21 31587861

Wen-hui Wen-hui, MD, PhD

principal investigator · Shanghai Zhongshan Hospital

Wen-Quan Wang, MD, PhD

principal investigator · Shanghai Zhongshan Hospital

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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