Clinical trial · Observational
CtDNA-guided Maintenance Therapy in Pancreatic Cancer
A Prospective Single-center Observational Study: ctDNA-guided Maintenance Therapy for Postoperative Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Experiment Group
- description
- 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
Primary outcomes (1)
- measure
- 2-year DFS rate
- timeFrame
- At the timepoint of 2 years after surgery
- description
- the proportion of cancer patients who remain free of disease recurrence or death from any cause within 2 years after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available