Using ctDNA to guide capecitabine maintenance after pancreatic cancer surgery
A Prospective Single-center Observational Study: ctDNA-guided Maintenance Therapy for Postoperative Pancreatic Cancer
This project tests whether blood ctDNA (MRD) can guide giving capecitabine as maintenance after standard adjuvant chemotherapy for people with resectable pancreatic cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT07054879 on ClinicalTrials.gov |
What this trial studies
This prospective, large-scale observational study will follow adults who had R0 resection for pancreatic ductal adenocarcinoma and received standard adjuvant therapy including gemcitabine plus capecitabine. Participants will undergo serial ctDNA-MRD blood testing after surgery and during follow-up to guide selection of postoperative capecitabine monotherapy maintenance and to monitor for molecular recurrence. The study will collect safety and efficacy outcomes, including recurrence-free and overall survival, and correlate them with ctDNA status. All procedures, including clinic visits and blood draws, are conducted at the sponsoring hospital without investigational drugs.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed resectable PDAC who had an R0 resection within 3 months, good performance status (ECOG 0–1), and who received standard adjuvant gemcitabine plus capecitabine are ideal candidates.
Not a fit: Patients with metastatic or locally advanced disease, poor performance status, significant organ dysfunction, recent other malignancies, or who cannot tolerate capecitabine are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could personalize postoperative care and help prevent or delay cancer recurrence by targeting maintenance therapy to patients with ctDNA-detected MRD.
How similar studies have performed: ctDNA-guided MRD strategies have shown promise in other tumor types, but ctDNA-guided maintenance therapy in resectable pancreatic cancer remains relatively novel and not yet widely proven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nanjing, Jiangsu
- Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Juan Du, professor
- Email: dujuanglyy@163.com
- Phone: +8613951826526
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.