CClinicalTrials.gg
RecruitingNCT05802394MAP-03Updated Apr 12, 2023

The Value of Molecular Residual Disease Monitoring Based on ctDNA in Borderline Resectable or Locally Advanced Pancreatic Cancer

An interventional study of Later-line therapy in Pancreatic Cancer and Locally Advanced, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-12.

Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Feb 2023; still recruiting 3 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Pancreatic Cancer
  • Locally Advanced
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's planned enrollment of 100 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • DrugLater-line therapy

    Another chemotherapy regimen, targeted therapy, or immunotherapy

06

What researchers measure

Primary outcomes

  1. Resection rate

    Proportion of patients who receive surgical resection

    Time frame: Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)

Secondary outcomes

  1. Overall survival

    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)

  2. Progression-free survival

    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)

  3. R0 resection rate

    Proportion of patients who receive R0 surgical resection

    Time frame: Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)

  4. Major pathological response

    ≤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 outcomes

  1. The prognostic value of MRD

    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)

  2. The prognostic role of targeted therapy selected based on MRD

    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)

07

Study locations

1 of 1 sites recruiting
  • Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
    Beijing, 100032, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05802394
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Sponsor
First posted
Apr 6, 2023
Start date
Feb 1, 2023
Primary completion
Feb 1, 2026 (estimated)
Completion
Feb 1, 2030 (estimated)
Last update
Apr 12, 2023

Study contacts

Chunmei Bai, MD
Contact
tangh160706@163.com
010-69158764 ext. +86
Chunmei Bai, MD
principal investigator · Peking Union Medical College Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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