NCT07054879 CtDNA-guided Maintenance Therapy in Pancreatic Cancer
| NCT ID | NCT07054879 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
| Condition | Pancreatic Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2024-11-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07054879 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07054879 currently recruiting?
Yes, NCT07054879 is actively recruiting participants. Contact the research team at dujuanglyy@163.com for enrollment information.
Where is the NCT07054879 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07054879 clinical trial?
NCT07054879 is sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. The trial plans to enroll 70 participants.
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