Back to resultsThe Value of Molecular Residual Disease Monitoring Based on ctDNA in Advanced or Metastatic Pancreatic Cancer (MAP-01)
Primary Purpose
Pancreatic Cancer, Advanced Cancer, Metastatic Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Later-line therapy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility 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.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
MRD-guided
Routine treatment
Arm Description
Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will receive a later-line therapy.
Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will continued their current therapy.
Outcomes
Primary Outcome Measures
Progression-free survival
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
The date of first-line chemotherpay initiation to death due to any cause.
Full Information
NCT ID
NCT05802420
First Posted
March 27, 2023
Last Updated
April 10, 2023
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05802420
Brief Title
The Value of Molecular Residual Disease Monitoring Based on ctDNA in Advanced or Metastatic Pancreatic Cancer
Acronym
MAP-01
Official Title
The Value of Molecular Residual Disease Monitoring Based on ctDNA in Advanced or Metastatic Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Advanced Cancer, Metastatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MRD-guided
Arm Type
Experimental
Arm Description
Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will receive a later-line therapy.
Arm Title
Routine treatment
Arm Type
No Intervention
Arm Description
Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will continued their current therapy.
Intervention Type
Drug
Intervention Name(s)
Later-line therapy
Intervention Description
Another chemotherapy regimen, targeted therapy, or immunotherapy
Primary Outcome Measure Information:
Title
Progression-free survival
Description
The date of first-line chemotherpay initiation to tumor progression or death due to any cause in the absence of progression.
Time Frame
Baseline until death from any cause (up to approximately 24 months)
Secondary Outcome Measure Information:
Title
Overall survival
Description
The date of first-line chemotherpay initiation to death due to any cause.
Time Frame
Baseline until death from any cause (up to approximately 24 months)
Other Pre-specified Outcome Measures:
Title
The prognostic value of MRD
Description
The prognostic value of baseline MRD and dynamic MRD changes
Time Frame
Baseline until death from any cause (up to approximately 24 months)
Title
The prognostic role of targeted therapy selected based on MRD
Description
The prognostic role of targeted therapy selected based on MRD
Time Frame
Baseline until death from any cause (up to approximately 24 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunmei Bai, MD
Phone
010-69158764
Ext
+86
Email
tangh160706@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Tang, MD
Phone
010-69158761
Ext
+86
Email
tangh160706@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunmei Bai, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunmei Bai, MD
Phone
010-69168764
Email
tangh160706@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Value of Molecular Residual Disease Monitoring Based on ctDNA in Advanced or Metastatic Pancreatic Cancer
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