The Value of Molecular Residual Disease Monitoring Based on ctDNA in Resected Pancreatic Cancer

Not Applicable

Recruiting

• Conditions: Resectable Carcinoma; Pancreatic Cancer
• Interventions: Drug: Later-line therapy

• Registration Number: NCT05802407
• 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 resected 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 adjuvant 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: 2026-02-01
• Study Completion: 2030-02-01

Recruitment & Eligibility

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

Inclusion Criteria

• patients with pancreatic cancer who had undergone curative-intent surgery (R0 or R1 resection);
• 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 adjuvant 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
Disease-free survival	Baseline until death from any cause (up to approximately 36 months)	The date of adjuvant chemotherpay initiation to tumor recurrence, local-regional or distant metastases, or death due to any cause.

Secondary Outcome Measures

Name	Time	Method
Overall survival	Baseline until death from any cause (up to approximately 60 months)	The date of adjuvant chemotherpay initiation to death due to any cause.

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