Back to resultsThe Value of Molecular Residual Disease Monitoring Based on ctDNA in Borderline Resectable or Locally Advanced Pancreatic Cancer (MAP-03)
Primary Purpose
Pancreatic Cancer, Locally Advanced
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 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.
Sites / Locations
- Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeRecruiting
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
Resection rate
Proportion of patients who receive surgical resection
Secondary Outcome Measures
Overall survival
The date of conversion therapy initiation to death due to any cause.
Progression-free survival
The date of conversion therapy initiation to tumor progression or death due to any cause in the absence of progression.
R0 resection rate
Proportion of patients who receive R0 surgical resection
Major pathological response
≤10% of the viable tumor cell in resected sample
Full Information
NCT ID
NCT05802394
First Posted
March 27, 2023
Last Updated
April 10, 2023
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05802394
Brief Title
The Value of Molecular Residual Disease Monitoring Based on ctDNA in Borderline Resectable or Locally Advanced Pancreatic Cancer
Acronym
MAP-03
Official Title
The Value of Molecular Residual Disease Monitoring Based on ctDNA in Borderline Resectable or Locally Advanced 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, 2026 (Anticipated)
Study Completion Date
February 1, 2030 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Locally Advanced
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
Resection rate
Description
Proportion of patients who receive surgical resection
Time Frame
Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)
Secondary Outcome Measure Information:
Title
Overall survival
Description
The date of conversion therapy initiation to death due to any cause.
Time Frame
Baseline until PD or death, whichever occurs first (up to approximately 24 months)
Title
Progression-free survival
Description
The date of conversion therapy initiation to tumor progression or death due to any cause in the absence of progression.
Time Frame
Baseline until PD or death, whichever occurs first (up to approximately 24 months)
Title
R0 resection rate
Description
Proportion of patients who receive R0 surgical resection
Time Frame
Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)
Title
Major pathological response
Description
≤10% of the viable tumor cell in resected sample
Time Frame
Baseline until operation, PD or death, whichever occurs first (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 PD or death, whichever occurs first (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 PD or death, whichever occurs first (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 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.
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
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
Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunmei Bai, M.D.
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 Borderline Resectable or Locally Advanced Pancreatic Cancer
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