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

NCT05848154 | Unknown DMC

• 1 other identifier: ZSPAC-07
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Pancreatic Neoplasms; Circulating tumor DNA; Neoadjuvant Therapy; Treatment Outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Rate of adverse reactions

  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

  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

  One week during therapy and 3 months thereafter up to 48 months.

• 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

  Up to 24 months.

Study Arms (1)

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

ctDNA detection DIAGNOSTIC_TEST

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.

ctDNA detection group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Fudan University: collaborator
• Amoy Diagnostics: collaborator

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Wen-hui Wen-hui, MD, PhD

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

• Wen-Quan Wang, MD, PhD

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen-Quan Wang, MD, PhD

CONTACT

+86 21 31587861; wang.wenquan@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2023
• First Posted: May 8, 2023
• Study Start: June 1, 2023
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)