Pancreatic CancerNCT07054879
CtDNA-guided Maintenance Therapy in Pancreatic Cancer
An observational study of Pancreatic Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pancreatic caner patients with R0 surgery
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Juan Du, Professor, +8613951826526, dujuanglyy@163.com
About this study
Official title: A Prospective Single-center Observational Study: ctDNA-guided Maintenance Therapy for Postoperative Pancreatic Cancer
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
- Pancreatic Cancer
- Keywords
- pancreatic cancer, maintenance therapy, ctDNA, capecitabine maintenance therapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year DFS rate
the proportion of cancer patients who remain free of disease recurrence or death from any cause within 2 years after surgery
Measured: At the timepoint of 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Nov 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Du Juan, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054879
- Sponsor's protocol ID
- PC-Maintenance therapy
- Status last verified
- Jun 2025
- First submitted
- 27 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-center Observational Study: ctDNA-guided Maintenance Therapy for Postoperative Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07054879
- Acronym / sponsor ID
- PC-Maintenance therapy
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer, maintenance therapy, ctDNA, capecitabine maintenance therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pancreatic caner patients with R0 surgery
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
2-year DFS rate
Time frame: At the timepoint of 2 years after surgery
the proportion of cancer patients who remain free of disease recurrence or death from any cause within 2 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Du, professor (+8613951826526, dujuanglyy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year DFS rate (time frame: At the timepoint of 2 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.