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

NCT05802394 | Recruiting DMC

• 1 other identifier: K3378-03
• 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 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.

Conditions

Pancreatic Cancer; Locally Advanced

Outcome Measures

Primary Outcomes (1)

• Resection rate

  Proportion of patients who receive surgical resection

  Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)

Secondary Outcomes (4)

• Overall survival

  Baseline until PD or death, whichever occurs first (up to approximately 24 months)

• Progression-free survival

  Baseline until PD or death, whichever occurs first (up to approximately 24 months)

• R0 resection rate

  Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)

• Major pathological response

  Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)

Other Outcomes (2)

• The prognostic value of MRD

  Baseline until PD or death, whichever occurs first (up to approximately 24 months)

• The prognostic role of targeted therapy selected based on MRD

  Baseline until PD or death, whichever occurs first (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 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.

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)

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

Beijing, 100032, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Chunmei Bai, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunmei Bai, MD

CONTACT

010-69158764; 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, 2026
• Study Completion (Estimated): February 1, 2030
• Last Updated: April 12, 2023

Record last verified: 2023-03

Locations

CN (1)