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

NCT05802420 | Unknown DMC

• 1 other identifier: K3378-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer; Advanced Cancer; Metastatic Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  The date of first-line chemotherpay initiation to tumor progression or death due to any cause in the absence of progression.

  Baseline until death from any cause (up to approximately 24 months)

Secondary Outcomes (1)

• Overall survival

  Baseline until death from any cause (up to approximately 24 months)

Other Outcomes (2)

• The prognostic value of MRD

  Baseline until death from any cause (up to approximately 24 months)

• The prognostic role of targeted therapy selected based on MRD

  Baseline until death from any cause (up to approximately 24 months)

Study Arms (2)

MRD-guided

EXPERIMENTAL

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

Drug: Later-line therapy

Routine treatment

NO INTERVENTION

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

Interventions

Later-line therapy DRUG

Another chemotherapy regimen, targeted therapy, or immunotherapy

MRD-guided

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chunmei Bai, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunmei Bai, MD

CONTACT

010-69158764; tangh160706@163.com

Hui Tang, MD

CONTACT

010-69158761; tangh160706@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 6, 2023
• Study Start: February 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: April 12, 2023

Record last verified: 2023-03

Locations

CN (1)