MRD in PAAD Adjuvant Therapy | NCT06867146

Studies
MRD in PAAD Adjuvant Therapy

NCT06867146

Sponsor

Peking Union Medical College Hospital

Status

Active, not recruiting

Last Update Posted

Mar 10, 2025Actual

Enrollment

60Estimated

Phase

Not Applicable

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

Interventions

Three-drug chemotherapy group
two-drug chemotherapy group

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2024Actual

Primary Completion Date

Dec 30, 2026Estimated

Completion Date

Dec 30, 2027Estimated

First Submitted Date

Nov 18, 2024

First Submission Date that Met QC Criteria

Mar 7, 2025

First Posted Date

Mar 10, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2025

Last Update Posted Date

Mar 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MRD postive	Sham Comparator		Drug: Three-drug chemotherapy group
MRD negative	Active Comparator		Drug: two-drug chemotherapy group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Three-drug chemotherapy group	Drug	Three-drug chemotherapy group, mFOLFIRINOX, including 5-fluorouracil, leucovorin, oxaliplatin and irinotecan.	MRD postive

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.	up to 18 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital		Beijing	Beijing Municipality	100730	China

Intervention Model Description

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

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms
D004066	Digestive System Diseases
D010182	Pancreatic Diseases
D004700	Endocrine System Diseases