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The Value of Molecular Residual Disease Monitoring Based on ctDNA in Resected Pancreatic Cancer (MAP-02)

Primary Purpose

Pancreatic Cancer, Resectable Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Later-line therapy
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients with pancreatic cancer who had undergone curative-intent surgery (R0 or R1 resection); 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 adjuvant 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

Disease-free survival
The date of adjuvant chemotherpay initiation to tumor recurrence, local-regional or distant metastases, or death due to any cause.

Secondary Outcome Measures

Overall survival
The date of adjuvant chemotherpay initiation to death due to any cause.

Full Information

First Posted
March 27, 2023
Last Updated
April 10, 2023
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05802407
Brief Title
The Value of Molecular Residual Disease Monitoring Based on ctDNA in Resected Pancreatic Cancer
Acronym
MAP-02
Official Title
The Value of Molecular Residual Disease Monitoring Based on ctDNA in Resected 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 resected 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 adjuvant 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, Resectable Carcinoma

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
Disease-free survival
Description
The date of adjuvant chemotherpay initiation to tumor recurrence, local-regional or distant metastases, or death due to any cause.
Time Frame
Baseline until death from any cause (up to approximately 36 months)
Secondary Outcome Measure Information:
Title
Overall survival
Description
The date of adjuvant chemotherpay initiation to death due to any cause.
Time Frame
Baseline until death from any cause (up to approximately 60 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 60 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 60 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with pancreatic cancer who had undergone curative-intent surgery (R0 or R1 resection); 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 adjuvant 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 Resected Pancreatic Cancer

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