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

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05802407

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

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 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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Resectable Carcinoma	Drug: Later-line therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Value of Molecular Residual Disease Monitoring Based on ctDNA in Resected Pancreatic Cancer

Actual Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2026

Anticipated Study Completion Date :

Feb 1, 2030

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.

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

Disease-free survival [Baseline until death from any cause (up to approximately 36 months)]
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 [Baseline until death from any cause (up to approximately 60 months)]
The date of adjuvant 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 60 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 60 months)]
The prognostic role of targeted therapy selected based on MRD

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing		China	100032

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.

Responsible Party:

Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT05802407

Other Study ID Numbers:

K3378-02

First Posted:

Apr 6, 2023

Last Update Posted:

Apr 12, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pancreatic Neoplasms

Study Results

No Results Posted as of Apr 12, 2023