The Value Of Molecular Residual Disease Monitoring Based On CtDNA In Borderline Resectable Or Locally Advanced Pancreatic Cancer

Study Overview

The Value of Molecular Residual Disease Monitoring Based on ctDNA in Borderline Resectable or Locally Advanced Pancreatic Cancer

The goal of this clinical trial is to explore the value of molecular residual disease (MRD) monitoring based on ctDNA in borderline resectable or locally advanced pancreatic cancer. The main questions it aims to answer are: * prognostic value of baseline MRD; * the role of MRD dynamic changes after treatment in guiding treatment. Peripheral blood derived from participants will be obtained for MRD test before conversion therapy initiation and at the first imaging assessment after chemotherapy.

N/A

Pancreatic Cancer
Locally Advanced

DRUG: Later-line therapy

K3378-03

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 2023-03-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-04-10
First Submitted that Met QC Criteria 2023-03-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-04-12
First Posted (ACTUAL) 2023-04-06	Results First Posted N/A	Last Verified 2023-03

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:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: MRD-guided Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will receive a later-line therapy.	DRUG: Later-line therapy Another chemotherapy regimen, targeted therapy, or immunotherapy
NO_INTERVENTION: Routine treatment Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will continued their current therapy.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: MRD-guided

Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will receive a later-line therapy.

DRUG: Later-line therapy

Another chemotherapy regimen, targeted therapy, or immunotherapy

NO_INTERVENTION: Routine treatment

Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will continued their current therapy.

Primary Outcome Measures	Measure Description	Time Frame
Resection rate	Proportion of patients who receive surgical resection	Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)

Secondary Outcome Measures	Measure Description	Time Frame
Overall survival	The date of conversion therapy initiation to death due to any cause.	Baseline until PD or death, whichever occurs first (up to approximately 24 months)
Progression-free survival	The date of conversion therapy initiation to tumor progression or death due to any cause in the absence of progression.	Baseline until PD or death, whichever occurs first (up to approximately 24 months)
R0 resection rate	Proportion of patients who receive R0 surgical resection	Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)
Major pathological response	≤10% of the viable tumor cell in resected sample	Baseline until operation, PD or death, whichever occurs first (up to approximately 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: Chunmei Bai, MD

Phone Number: 010-69158764

Email: tangh160706@163.com

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:

patients with histologically confirmed borderline resectable or locally advanced pancreatic cancer;
conversion therapy was planned;
both sexes, age ≥18 years old;
ECOG performance status score ≤2;
the expected survival time was ≥3 months.

a known diagnosis of pancreatic cancer other than ductal adenocarcinoma;
treated with any systemic antitumor treatment before first-line chemotherapy onset;
died or lost to follow-up within one month after the initiation of first-line chemotherpay;
combined with other primary malignances.

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Chunmei Bai, MD, Peking Union Medical College 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

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record