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Recruiting NCT05802407

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

No phase Interventional Pancreatic Cancer Resectable Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Later-line therapy.
Who it may be relevant to
Registry conditions: Pancreatic Cancer, Resectable Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Drug Later-line therapy
    Another chemotherapy regimen, targeted therapy, or immunotherapy

Primary outcome measures

  • Disease-free survival [Time frame: Baseline until death from any cause (up to approximately 36 months)]
Secondary outcome measures (1)
  • Overall survival [Time frame: Baseline until death from any cause (up to approximately 60 months)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of — Beijing

Identifiers

NCT: NCT05802407 · K3378-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗