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

Pancreatic Cancer Clinical Trial

— MAP-03  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05802394
• Other study ID #: K3378-03
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: February 1, 2030

Study information

• Verified date: March 2023
• Source: Peking Union Medical College Hospital
• Contact: Chunmei Bai, MD
• Phone: 010-69158764
• Email: tangh160706[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 1, 2030
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Locally Advanced
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The prognostic value of MRD	The prognostic value of baseline MRD and dynamic MRD changes	Baseline until PD or death, whichever occurs first (up to approximately 24 months)
Other	The prognostic role of targeted therapy selected based on MRD	The prognostic role of targeted therapy selected based on MRD	Baseline until PD or death, whichever occurs first (up to approximately 24 months)
Primary	Resection rate	Proportion of patients who receive surgical resection	Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)
Secondary	Overall survival	The date of conversion therapy initiation to death due to any cause.	Baseline until PD or death, whichever occurs first (up to approximately 24 months)
Secondary	Progression-free survival	The date of conversion therapy initiation to tumor progression or death due to any cause in the absence of progression.	Baseline until PD or death, whichever occurs first (up to approximately 24 months)
Secondary	R0 resection rate	Proportion of patients who receive R0 surgical resection	Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)
Secondary	Major pathological response	=10% of the viable tumor cell in resected sample	Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)