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

NCT ID: NCT05802407

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2030-02-01

Brief Summary

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.

Conditions

Pancreatic Cancer; Resectable Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MRD-guided

Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will receive a later-line therapy.

Group Type: EXPERIMENTAL

Later-line therapy

Intervention Type: DRUG

Another chemotherapy regimen, targeted therapy, or immunotherapy

Routine treatment

Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will continued their current therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Later-line therapy

Another chemotherapy regimen, targeted therapy, or immunotherapy

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chunmei Bai, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Chunmei Bai, MD

Role: CONTACT

tangh160706@163.com

010-69158764 ext. +86

Facility Contacts

Chunmei Bai, M.D.

Role: primary

tangh160706@163.com

010-69168764

Other Identifiers

K3378-02

Identifier Type: -

Identifier Source: org_study_id