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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pancreatic Cancer, Locally Advanced

Intervention / Treatment
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* Drug: Later-line therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRD-guided<br>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<br>* Another chemotherapy regimen, targeted therapy, or immunotherapy<br>|
| No Intervention: Routine treatment<br>Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will continued their current therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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) |