CtDNA-guided Maintenance Therapy in Pancreatic Cancer

NCT ID: NCT07054879

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2027-01-01

Brief Summary

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This study aims to conduct a large-scale prospective clinical trial to evaluate the efficacy and safety of capecitabine monotherapy as maintenance treatment following standard adjuvant chemotherapy (gemcitabine plus capecitabine) in patients with resectable pancreatic cancer, and to analyze whether ctDNA-MRD testing can guide the selection of postoperative maintenance therapy.

Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Experiment Group

Patients received 6 cycles of standard adjuvant chemotherapy (gemcitabine plus capecitabine), followed by capecitabine monotherapy as maintenance treatment based on the patient's clinical condition

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years, male or female
* Histologically or cytologically confirmed primary diagnosis of pancreatic ductal adenocarcinoma (PDAC)
* No evidence of distant metastasis (M0)
* Underwent R0 radical resection within 3 months prior to enrollment
* ECOG performance status of 0-1
* Life expectancy ≥3 months
* Patient or legal guardian is able to understand the study requirements and willing to provide written informed consent

Exclusion Criteria

* Prior history of radiotherapy, chemotherapy or surgical treatment for pancreatic cancer
* Concurrent severe organ dysfunction or hematologic disorders
* Tumor involvement of celiac axis or superior mesenteric artery, locally advanced disease, or presence of distant metastases
* Poor general condition deemed unable to tolerate chemotherapy
* History of other malignancies within past 5 years (except adequately treated carcinoma in situ of cervix or basal cell carcinoma of skin)
* Any severe or uncontrolled systemic disease that may affect risk/benefit assessment, including but not limited to: uncontrolled hypertension, active hepatitis B or C infection, HIV infection
* Patient or guardian unable to comprehend study objectives and requirements
* Any other condition that in the investigator's judgment would make the patient unsuitable for study participation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role lead

Responsible Party

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Du Juan

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Juan Du, professor

Role: CONTACT

+8613951826526

Facility Contacts

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Juan Du, Professor

Role: primary

+8613951826526

Other Identifiers

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PC-Maintenance therapy

Identifier Type: -

Identifier Source: org_study_id

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