Borderline Resectable Pancreatic AdenocarcinomaMRDNCT07080021
A Cohort Study on ctDNA MRD in Neoadjuvant Therapy for Pancreatic Cancer
An observational study of Borderline Resectable Pancreatic Adenocarcinoma and Resectable Pancreatic Adenocarcinoma, run by Ruijin Hospital at 2 sites in China.
Trial summary
The goal of this prospective observational study is to learn about the clinical utility of dynamic ctDNA-based Minimal Residual Disease (MRD) monitoring in patients with borderline resectable pancreatic cancer undergoing neoadjuvant therapy. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Borderline Resectable Pancreatic Adenocarcinoma, Resectable Pancreatic Adenocarcinoma
- What is being tested?
- Standard Reagents, Pancreatic Cancer
- How many people
- 119 participants
- Where
- 2 sitesChina
- Study dates
- 20 May 2025to 20 Nov 2027
- How long will I take part?
- 18 Months
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: The study population consists of 119 patients aged 18-75 years with pathologically confirmed pancreatic cancer meeting NCCN-defined criteria for high-risk resectable, borderline resectable, or locally advanced stage. Eligibility requires multidisciplinary discussion (MDT) confirmation of suitability for neoadjuvant therapy, ECOG performance status ≤1, estimated survival ≥6 months, no severe organ dysfunction, and provision of informed consent. Subjects with distant metastasis, prior anti-tumor therapy, or concurrent malignancies are excluded.
Who may be able to join
- Subjects meeting ALL of the following criteria will be enrolled:
- Age and Gender :Aged 18-75 years, regardless of gender.
- Diagnosis and Disease Stage :
- Pathologically confirmed pancreatic cancer, meeting NCCN guideline criteria for:
- High-risk resectable (meeting ≥1 criterion):
- Luminal stenosis of the portal vein or superior mesenteric vein on imaging;
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- Radiographic stage T≥3 or N≥1;
- Serum CA19-9 ≥1000 U/mL (after resolution of jaundice);
- Confirmed regional lymph node metastasis;
- Significant weight loss (>10% baseline) or severe pain requiring opioids.
- Borderline resectable :
- Tumor involving the common hepatic artery without celiac axis contact;
- Tumor contact with SMA ≤180°.
- Locally advanced (unresectable):
- Tumor encasement (>180°) of the SMA, celiac axis, or common hepatic artery;
- Unreconstructable involvement of SMV/portal vein;
- No distant metastasis.
- Treatment Suitability :Deemed suitable for neoadjuvant therapy after multidisciplinary team (MDT) discussion .
- Performance Status :ECOG (Eastern Cooperative Oncology Group) performance status ≤1 .
- Life Expectancy :Estimated survival ≥6 months.
- Organ Function :No severe cardiac, hepatic, or renal dysfunction, including:
- ALT/AST ≤3×ULN (upper limit of normal); Serum creatinine ≤1.5×ULN .
- Informed Consent :Signed written informed consent voluntarily provided.
Who cannot join
- Subjects meeting ANY of the following criteria will be excluded:
- Distant Metastasis Radiographically confirmed distant metastatic lesions.
- Prior Anti-Tumor Therapy History of any prior anti-tumor treatment, including:
- Systemic chemotherapy Radiotherapy Interventional therapy Immunotherapy Targeted therapy Anti-tumor traditional Chinese medicine therapy.
- Concurrent Malignancy Diagnosis of other active malignancies.
- Pregnancy or Lactation Female subjects who are pregnant or breastfeeding.
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- Drug Allergy Hypersensitivity to any agents in the guideline-recommended first-line neoadjuvant regimen .
- Transplantation History Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation .
- Immunodeficiency Disorders Congenital or acquired immunodeficiency, including:
- Human Immunodeficiency Virus (HIV) infection;
- Active Hepatitis B :
- HBsAg-positive andHBV-DNA ≥10,000 copies/mL (≥2,000 IU/mL) at screening;
- Active Hepatitis C :
- HCV-Ab-positive andHCV-RNA positive at screening; Co-infection with HBV and HC
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai
Baiyong Shen
- Recruiting
Ruijin hospital
Shanghai
Fanlu Li, +86 021-64370045-678805, lfl12522@rjh.com.cn
About this study
Official title: A Prospective Observational Cohort Study on Longitudinal Monitoring of ctDNA MRD in Neoadjuvant Therapy for Pancreatic Cancer
The goal of this prospective observational study is to learn about the clinical utility of dynamic ctDNA-based Minimal Residual Disease (MRD) monitoring in patients with borderline resectable pancreatic cancer undergoing neoadjuvant therapy. The main questions it aims to answer are:
- Does MRD negativity correlate with improved surgical outcomes (R0 resection rates) and long-term survival (Disease-Free Survival [DFS] / Overall Survival [OS])?
- Can serial MRD status assessments guide optimal neoadjuvant therapy duration? Participants (n=119) will be adults aged 18-75 years with histologically confirmed pancreatic cancer meeting NCCN criteria for borderline resectable/high-risk resectable/locally advanced disease, deemed eligible for neoadjuvant therapy by a multidisciplinary team (MDT) and with ECOG performance status ≤1. Patients with distant metastasis, prior anticancer therapy, or concurrent malignancies are excluded.
Read more
During 24-month study period (12-month recruitment + 12-month follow-up), enrolled subjects will:
- Receive standard-of-care neoadjuvant therapy/surgery per physician's decision.
- Undo serial blood draws for ctDNA-MRD testing at predefined timepoints.
- Be followed for DFS/OS outcomes for 18 months. This non-interventional study is conducted at Ruijin Hospital Pancreatic Surgery Department.
Read the detailed description
Research Summary Study Name ：Prospective and Observational Study on MRD Dynamic Monitoring of Neoadjuvant Therapy for Borderline Resectable Pancreatic Cancer
Study Introduction ：This study investigates borderline resectable pancreatic cancer patients undergoing neoadjuvant therapy followed by surgical resection. It dynamically monitors Minimal Residual Disease (MRD) using circulating tumor DNA (ctDNA) technology to examine the correlation between MRD status at various monitoring points and patients' R0 resection rates, Disease-Free Survival (DFS), and Overall Survival (OS). The hypothesis states that MRD-negative patients have significantly better prognosis than MRD-positive patients.
Primary Objective ：To evaluate the correlation between ctDNA-based MRD status at different monitoring points during neoadjuvant therapy and therapeutic efficacy/prognosis (DFS/OS). To explore whether MRD status can help determine the optimal duration of neoadjuvant therapy.
Study Subjects Sample size : 119 cases
Inclusion criteria :
Age 18-75 years Pathologically confirmed pancreatic cancer Meets NCCN criteria for high-risk resectable, borderline resectable, or locally advanced disease MDT discussion confirming suitability for neoadjuvant therapy ECOG score ≤1
Exclusion criteria :
Distant metastasis History of anti-tumor therapy Concurrent other malignancies
Study Unit/Location ：Department of Pancreatic Surgery, Ruijin Hospital
Study Intervention ：This is a non-interventional study. Neoadjuvant therapy regimens and surgical approaches are determined solely by attending physicians according to clinical treatment standards.
Study Duration ：24 months (12 months recruitment + 12 months follow-up)
Subject Participation Duration ：Each subject requires 18 months to complete the study.
Protocol: A total of 119 subjects will be enrolled. Each subject will undergo 4 to 8 cycles of neoadjuvant therapy . Tumor tissue sampling will be performed once either via pre-neoadjuvant biopsy or surgical resection (biopsy-derived tissue is preferred ) and paired with serial peripheral blood sampling (for MRD detection ), as detailed in the accompanying schematic diagram.
Peripheral Blood Collection Schedule:
- Pre-neoadjuvant treatment： End of Cycle 2 End of Cycle 3 End of Cycle 4 End of Cycle 6
- Pre-surgery； 3.1 month Post-surgery. Sample Volume: 10 ml whole blood collected at each time point during neoadjuvant therapy; 20 ml whole blood collected at baseline (pre-treatment) , pre-surgery , and 1-month post-surgery .
Sample Handling: All collected samples will be transferred to the central laboratory for subsequent analysis. Analysis will include: high-throughput sequencing (NGS) for evaluation of Minimal Residual Disease (MRD) status .
- Being tested
- Standard Reagents, Pancreatic Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Reagents, Pancreatic CancerDrug
This is a non-interventional study. Neoadjuvant therapy regimens and surgical approaches are determined solely by attending physicians according to clinical treatment standards.
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between ctDNA-MRD status at serial monitoring points during neoadjuvant therapy and therapeutic efficacy (R0 resection).
To evaluate the correlation between ctDNA-MRD status at serial monitoring points during neoadjuvant therapy and therapeutic efficacy (R0 resection).
Measured: 1 years
Secondary outcomes (1)
The correlation between ctDNA-MRD status at serial monitoring points during neoadjuvant therapy and survival outcomes (DFS/OS).
To evaluate the correlation between ctDNA-MRD status at serial monitoring points during neoadjuvant therapy and survival outcomes (DFS/OS).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start20 May 2025
- Primary completion20 May 2026 (estimated)
- Study completion20 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Resectable Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- 119 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080021
- Sponsor's protocol ID
- KY01003 v2.0 /20200603
- Acronym
- MRD
- Status last verified
- May 2025
- First submitted
- 15 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Cohort Study on Longitudinal Monitoring of ctDNA MRD in Neoadjuvant Therapy for Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07080021
- Acronym / sponsor ID
- MRD / KY01003 v2.0 /20200603
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 119 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 20 Nov 2027 (estimated)
- First posted
- 23 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.
The goal of this prospective observational study is to learn about the clinical utility of dynamic ctDNA-based Minimal Residual Disease (MRD) monitoring in patients with borderline resectable pancreatic cancer undergoing neoadjuvant therapy. The main questions it aims to answer are:
- Does MRD negativity correlate with improved surgical outcomes (R0 resection rates) and long-term survival (Disease-Free Survival [DFS] / Overall Survival [OS])?
- Can serial MRD status assessments guide optimal neoadjuvant therapy duration? Participants (n=119) will be adults aged 18-75 years with histologically confirmed pancreatic cancer meeting NCCN criteria for borderline resectable/high-risk resectable/locally advanced disease, deemed eligible for neoadjuvant therapy by a multidisciplinary team (MDT) and with ECOG performance status ≤1. Patients with distant metastasis, prior anticancer therapy, or concurrent malignancies are excluded.
During 24-month study period (12-month recruitment + 12-month follow-up), enrolled subjects will:
- Receive standard-of-care neoadjuvant therapy/surgery per physician's decision.
- Undo serial blood draws for ctDNA-MRD testing at predefined timepoints.
- Be followed for DFS/OS outcomes for 18 months. This non-interventional study is conducted at Ruijin Hospital Pancreatic Surgery Department.
Detailed description
Research Summary Study Name ：Prospective and Observational Study on MRD Dynamic Monitoring of Neoadjuvant Therapy for Borderline Resectable Pancreatic Cancer
Study Introduction ：This study investigates borderline resectable pancreatic cancer patients undergoing neoadjuvant therapy followed by surgical resection. It dynamically monitors Minimal Residual Disease (MRD) using circulating tumor DNA (ctDNA) technology to examine the correlation between MRD status at various monitoring points and patients' R0 resection rates, Disease-Free Survival (DFS), and Overall Survival (OS). The hypothesis states that MRD-negative patients have significantly better prognosis than MRD-positive patients.
Primary Objective ：To evaluate the correlation between ctDNA-based MRD status at different monitoring points during neoadjuvant therapy and therapeutic efficacy/prognosis (DFS/OS). To explore whether MRD status can help determine the optimal duration of neoadjuvant therapy.
Study Subjects Sample size : 119 cases
Inclusion criteria :
Age 18-75 years Pathologically confirmed pancreatic cancer Meets NCCN criteria for high-risk resectable, borderline resectable, or locally advanced disease MDT discussion confirming suitability for neoadjuvant therapy ECOG score ≤1
Exclusion criteria :
Distant metastasis History of anti-tumor therapy Concurrent other malignancies
Study Unit/Location ：Department of Pancreatic Surgery, Ruijin Hospital
Study Intervention ：This is a non-interventional study. Neoadjuvant therapy regimens and surgical approaches are determined solely by attending physicians according to clinical treatment standards.
Study Duration ：24 months (12 months recruitment + 12 months follow-up)
Subject Participation Duration ：Each subject requires 18 months to complete the study.
Protocol: A total of 119 subjects will be enrolled. Each subject will undergo 4 to 8 cycles of neoadjuvant therapy . Tumor tissue sampling will be performed once either via pre-neoadjuvant biopsy or surgical resection (biopsy-derived tissue is preferred ) and paired with serial peripheral blood sampling (for MRD detection ), as detailed in the accompanying schematic diagram.
Peripheral Blood Collection Schedule:
- Pre-neoadjuvant treatment： End of Cycle 2 End of Cycle 3 End of Cycle 4 End of Cycle 6
- Pre-surgery； 3.1 month Post-surgery. Sample Volume: 10 ml whole blood collected at each time point during neoadjuvant therapy; 20 ml whole blood collected at baseline (pre-treatment) , pre-surgery , and 1-month post-surgery .
Sample Handling: All collected samples will be transferred to the central laboratory for subsequent analysis. Analysis will include: high-throughput sequencing (NGS) for evaluation of Minimal Residual Disease (MRD) status .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of 119 patients aged 18-75 years with pathologically confirmed pancreatic cancer meeting NCCN-defined criteria for high-risk resectable, borderline resectable, or locally advanced stage. Eligibility requires multidisciplinary discussion (MDT) confirmation of suitability for neoadjuvant therapy, ECOG performance status ≤1, estimated survival ≥6 months, no severe organ dysfunction, and provision of informed consent. Subjects with distant metastasis, prior anti-tumor therapy, or concurrent malignancies are excluded.
Key inclusion criteria (23 listed)
- Subjects meeting ALL of the following criteria will be enrolled:
- ALT/AST ≤3×ULN (upper limit of normal); Serum creatinine ≤1.5×ULN .
Key exclusion criteria (14 listed)
- Subjects meeting ANY of the following criteria will be excluded:
- Systemic chemotherapy Radiotherapy Interventional therapy Immunotherapy Targeted therapy Anti-tumor traditional Chinese medicine therapy.
- Human Immunodeficiency Virus (HIV) infection;
- HBsAg-positive andHBV-DNA ≥10,000 copies/mL (≥2,000 IU/mL) at screening;
- HCV-Ab-positive andHCV-RNA positive at screening; Co-infection with HBV and HC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Reagents, Pancreatic CancerThis is a non-interventional study. Neoadjuvant therapy regimens and surgical approaches are determined solely by attending physicians according to clinical treatment standards. | Drug | – |
Primary outcome
The correlation between ctDNA-MRD status at serial monitoring points during neoadjuvant therapy and therapeutic efficacy (R0 resection).
Time frame: 1 years
To evaluate the correlation between ctDNA-MRD status at serial monitoring points during neoadjuvant therapy and therapeutic efficacy (R0 resection).
1 secondary outcome
The correlation between ctDNA-MRD status at serial monitoring points during neoadjuvant therapy and survival outcomes (DFS/OS).
Time frame: 2 years
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 29 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Borderline Resectable Pancreatic Adenocarcinoma and Resectable Pancreatic Adenocarcinoma, run by Ruijin Hospital at 2 sites 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 23 inclusion and 14 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 29 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 2 sites 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 Baiyong Shen, MD (+86 021-64370045-678805, lfl12522@rjh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between ctDNA-MRD status at serial monitoring points during neoadjuvant therapy and therapeutic efficacy (R0 resection). (time frame: 1 years). 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 29 Jul 2025.