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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Later-line therapy

    Drug

    Another chemotherapy regimen, targeted therapy, or immunotherapy

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: MRD-guidedExperimental treatment 1 intervention
Group B: Routine treatmentNo intervention 0 interventions

Trial outcomes

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)

Sponsors and contacts

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