MAP-01: The Value of Molecular Residual Disease Monitoring Based on ctDNA in Advanced or Metastatic Pancreatic Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MRD-guided 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
Another chemotherapy regimen, targeted therapy, or immunotherapy
|
| No Intervention: Routine treatment Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will continued their current therapy. |
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Other Outcome Measures
- The prognostic value of MRD [Baseline until death from any cause (up to approximately 24 months)]
The prognostic value of baseline MRD and dynamic MRD changes
- The prognostic role of targeted therapy selected based on MRD [Baseline until death from any cause (up to approximately 24 months)]
The prognostic role of targeted therapy selected based on MRD
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking Union Medical College Hospital | Beijing | Beijing | China | 100730 |
Sponsors and Collaborators
- Peking Union Medical College Hospital
Investigators
- Principal Investigator: Chunmei Bai, MD, Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- K3378-01