The Value of Molecular Residual Disease Monitoring Based on ctDNA in Borderline Resectable or Locally Advanced Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Later-line therapy.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer, Locally Advanced. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Later-line therapy
Another chemotherapy regimen, targeted therapy, or immunotherapy
Primary outcome measures
- Resection rate [Time frame: Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)]
Secondary outcome measures (4)
- Overall survival [Time frame: Baseline until PD or death, whichever occurs first (up to approximately 24 months)]
- Progression-free survival [Time frame: Baseline until PD or death, whichever occurs first (up to approximately 24 months)]
- R0 resection rate [Time frame: Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)]
- Major pathological response [Time frame: Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of — Beijing
Identifiers
NCT: NCT05802394 · K3378-03