Active, not recruitingNCT06867146Updated Mar 10, 2025

MRD in PAAD Adjuvant Therapy

An interventional study of Three-drug chemotherapy group and two-drug chemotherapy group in The Role of Molecular Residual Disease in the Treatment Strategy and Prognosis Prediction of Pancreatic Cancer Patients Undergoing Adjuvant Therapy, Molecular Residual Disease and Pancreatic Cancer, sponsored by Peking Union Medical College Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-03-10.

Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 60
Allocation: Non-randomized
Ages: 18 Years to 70 Years
Sex: All

Study 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 studied

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

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Keywords

pancreatic cancer

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's planned enrollment of 60 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

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Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Here's the translated and polished version of your content:
1. Patients clinically diagnosed with pancreatic cancer, staged I-III (AJCC V8.0), who are scheduled to undergo curative surgery.
2. No restrictions on gender; age between 18 and 70 years.
3. Eastern Cooperative Oncology Group (ECOG) performance status score: ≤2.
4. Expected survival time of ≥3 months.
5. 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.
6. Voluntary participation in this clinical study, with an understanding of the study procedures and the ability to sign an informed consent form.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 60 participants (estimated)

Study arms

Sham comparator
MRD postive
Drug: Three-drug chemotherapy group
Active comparator
MRD negative
Drug: two-drug chemotherapy group

Interventions

DrugThree-drug chemotherapy group
Three-drug chemotherapy group, mFOLFIRINOX, including 5-fluorouracil, leucovorin, oxaliplatin and irinotecan.
Drugtwo-drug chemotherapy group
two-drug chemotherapy group, including gemcitabine-based combination regimens (predominately gemcitabine/nab-paclitaxel or gemcitabine/capecitabine)

What researchers measure

Primary outcomes

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
Time frame: up to 18 months

Secondary outcomes

OS
OS measures the length of time from either the diagnosis or the start of treatment to the death of the patient, regardless of cause. Median follow-up time up to 18 months.
Time frame: up to 18 months

Study locations

1 site

Peking Union Medical College Hospital
Beijing, Beijing 100730, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06867146
Lead sponsor: Peking Union Medical College Hospital
Responsible party: Sponsor
First posted: Mar 10, 2025
Start date: Oct 15, 2024
Primary completion: Dec 30, 2026 (estimated)
Completion: Dec 30, 2027 (estimated)
Last update: Mar 10, 2025

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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