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

Not Applicable

Recruiting

• Conditions: Locally Advanced; Pancreatic Cancer
• Interventions: Drug: Later-line therapy

• Registration Number: NCT05802394
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-27
• Study First Submitted QC: 2023-03-27
• Study First Posted: 2023-04-06
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-12
• Primary Completion: 2026-02-01
• Study Completion: 2030-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Resection rate	Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)	Proportion of patients who receive surgical resection

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, China