The Value of Molecular Residual Disease Monitoring Based on ctDNA in Advanced or Metastatic Pancreatic Cancer

Not Applicable

Recruiting

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

• Registration Number: NCT05802420
• 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 advanced or metastatic 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 first-line chemotherapy 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: 2025-02-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

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

Inclusion Criteria

• patients with histologically confirmed unresectable advanced or metastatic pancreatic cancer;
• 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
Progression-free survival	Baseline until death from any cause (up to approximately 24 months)	The date of first-line chemotherpay initiation to tumor progression or death due to any cause in the absence of progression.

Secondary Outcome Measures

Name	Time	Method
Overall survival	Baseline until death from any cause (up to approximately 24 months)	The date of first-line chemotherpay initiation to death due to any cause.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China