MRD in PAAD Adjuvant Therapy

NCT06867146 | Active Not Recruiting

• 1 other identifier: K3378
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Our preliminary research has explored the detection efficacy of minimal residual disease (MRD) in pancreatic cancer. In patients with pancreatic cancer undergoing dual-agent adjuvant chemotherapy, the median recurrence-free survival (RFS) is approximately 13.9 months. Due to the high postoperative recurrence rate, short survival time, and intense systemic chemotherapy in pancreatic cancer patients, there is an urgent clinical need to more accurately identify which patients will benefit from adjuvant therapy. This study aims to evaluate the application value and guiding significance of peripheral blood MRD in the decision-making process for adjuvant treatment in patients with resected pancreatic cancer.

Conditions

The Role of Molecular Residual Disease in the Treatment Strategy and Prognosis Prediction of Pancreatic Cancer Patients Undergoing Adjuvant Therapy; Molecular Residual Disease; Pancreatic Cancer; Adjuvant Therapy

Keywords

pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• DFS

  DFS refers to the length of time after treatment during which a patient remains free of any signs or symptoms of the disease. It is primarily used in cancer research to measure the effectiveness of treatments in preventing recurrence. Median follow-up time up to 18 months

  up to 18 months

Secondary Outcomes (1)

• OS

  up to 18 months

Study Arms (2)

MRD postive

SHAM COMPARATOR

Drug: Three-drug chemotherapy group

MRD negative

ACTIVE COMPARATOR

Drug: two-drug chemotherapy group

Interventions

Three-drug chemotherapy group DRUG

Three-drug chemotherapy group, mFOLFIRINOX, including 5-fluorouracil, leucovorin, oxaliplatin and irinotecan.

MRD postive

two-drug chemotherapy group DRUG

two-drug chemotherapy group, including gemcitabine-based combination regimens (predominately gemcitabine/nab-paclitaxel or gemcitabine/capecitabine)

MRD negative

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Here's the translated and polished version of your content:
• Patients clinically diagnosed with pancreatic cancer, staged I-III (AJCC V8.0), who are scheduled to undergo curative surgery.
• No restrictions on gender; age between 18 and 70 years.
• Eastern Cooperative Oncology Group (ECOG) performance status score: ≤2.
• Expected survival time of ≥3 months.
• Willingness to comply with the study protocol for testing, treatment, and follow-up; consent to provide necessary clinical, pathological, and follow-up data for the study; and agreement to use the research data for future studies and product development.
• Voluntary participation in this clinical study, with an understanding of the study procedures and the ability to sign an informed consent form.

You may not qualify if:

• Patients who have had other malignancies within the five years prior to this study.
• Patients who have received any antitumor treatment within six months prior to enrollment.
• Patients with concomitant diseases that, in the investigator's judgment, pose a serious risk to patient safety or could affect the patient's ability to complete the study (such as poorly controlled hypertension, severe diabetes, thyroid disorders, psychiatric disorders, etc.), or any other conditions deemed unsuitable for participation.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

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 Design

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

Model Details: For patients with pathological stage I pancreatic cancer, if they are baseline MRD-positive after surgery, or MRD-negative but have high-risk recurrence factors (including perineural invasion, lymphovascular invasion, preoperative CA19-9 \> 180 U/ml, postoperative CA19-9 \> 37 U/ml, or extrapancreatic tumor infiltration), they will receive standard dual-agent chemotherapy, such as gemcitabine combined with nab-paclitaxel or capecitabine, with the chemotherapy regimen selected by the clinical doctor. If the patient is baseline MRD-negative and has no high-risk recurrence factors, they will be randomly assigned in a 1:1 ratio to either receive standard chemotherapy or be observed. For patients with pathological stage II-III pancreatic cancer, if they are baseline MRD-negative after surgery, they will receive standard dual-agent chemotherapy, such as gemcitabine combined with nab-paclitaxel or capecitabine, with the chemotherapy regimen selected by the clinical doctor. If the patient is ba

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: March 10, 2025
• Study Start: October 15, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 10, 2025

Record last verified: 2024-10

Locations

CN (1)