CtDNA-guided Maintenance Therapy in Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Single-center Observational Study: ctDNA-guided Maintenance Therapy for Postoperative Pancreatic Cancer
Overview
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.
Primary outcome measures
- 2-year DFS rate [Time frame: At the timepoint of 2 years after surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Nanjing Drum Tower Hospital — Nanjing
Identifiers
NCT: NCT07054879 · PC-Maintenance therapy