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Trial Title:
The Value of Molecular Residual Disease Monitoring Based on ctDNA in Borderline Resectable or Locally Advanced Pancreatic Cancer
NCT ID:
NCT05802394
Condition:
Pancreatic Cancer
Locally Advanced
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Later-line therapy
Description:
Another chemotherapy regimen, targeted therapy, or immunotherapy
Arm group label:
MRD-guided
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.
Criteria for eligibility:
Criteria:
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:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Address:
City:
Beijing
Zip:
100032
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunmei Bai, M.D.
Phone:
010-69168764
Email:
tangh160706@163.com
Start date:
February 1, 2023
Completion date:
February 1, 2030
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05802394
