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Trial Title: The Value of Molecular Residual Disease Monitoring Based on ctDNA in Advanced or Metastatic Pancreatic Cancer

NCT ID: NCT05802420

Condition: Pancreatic Cancer
Advanced Cancer
Metastatic Cancer

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 advanced or metastatic 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 first-line chemotherapy initiation and at the first imaging assessment after chemotherapy.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - patients with histologically confirmed unresectable advanced or metastatic pancreatic cancer; - 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: Peking Union Medical College Hospital

Address:
City: Beijing
Zip: 100730
Country: China

Status: Recruiting

Contact:
Last name: Chunmei Bai, MD

Phone: 010-69168764
Email: tangh160706@163.com

Start date: February 1, 2023

Completion date: February 1, 2025

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/NCT05802420

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