Pancreatic CancerMAP-03NCT05802394
The Value of Molecular Residual Disease Monitoring Based on ctDNA in Borderline Resectable or Locally Advanced Pancreatic Cancer
A study testing Later-line therapy in people with Pancreatic Cancer and Locally Advanced, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to explore the value of molecular residual disease (MRD) monitoring based on ctDNA in borderline resectable or locally advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Locally Advanced
- What is being tested?
- Later-line therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 1 Feb 2030
- Phase
- Interventional
- 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
Who may be able to join
- patients with histologically confirmed borderline resectable or locally advanced pancreatic cancer;
- conversion therapy was planned;
- both sexes, age ≥18 years old;
- ECOG performance status score ≤2;
- the expected survival time was ≥3 months.
Who cannot join
- a known diagnosis of pancreatic cancer other than ductal adenocarcinoma;
- treated with any systemic antitumor treatment before first-line chemotherapy onset;
- died or lost to follow-up within one month after the initiation of first-line chemotherpay;
- combined with other primary malignances.
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
Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, 100032
Chunmei Bai, M.D., 010-69168764, tangh160706@163.com
About this study
The goal of this clinical trial is to explore the value of molecular residual disease (MRD) monitoring based on ctDNA in borderline resectable or locally advanced pancreatic cancer. The main questions it aims to answer are:
- prognostic value of baseline MRD;
- the role of MRD dynamic changes after treatment in guiding treatment. Peripheral blood derived from participants will be obtained for MRD test before conversion therapy initiation and at the first imaging assessment after chemotherapy.
- Conditions
- Pancreatic Cancer, Locally Advanced
- Being tested
- Later-line 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.
Later-line therapyDrug
Another chemotherapy regimen, targeted therapy, or immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| MRD-guided | Experimental | Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will receive a later-line therapy. Receives: Drug: Later-line therapy |
| Routine treatment | No intervention | Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will continued their current therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resection rate
Proportion of patients who receive surgical resection
Measured: Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)
Secondary outcomes (4)
Overall survival
The date of conversion therapy initiation to death due to any cause.
Measured: Baseline until PD or death, whichever occurs first (up to approximately 24 months)
Progression-free survival
The date of conversion therapy initiation to tumor progression or death due to any cause in the absence of progression.
Measured: Baseline until PD or death, whichever occurs first (up to approximately 24 months)
R0 resection rate
Proportion of patients who receive R0 surgical resection
Measured: Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)
Major pathological response
≤10% of the viable tumor cell in resected sample
Measured: Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 Feb 2023
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2030 (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 Peking Union Medical College 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chunmei Bai, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802394
- Sponsor's protocol ID
- K3378-03
- Acronym
- MAP-03
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2023
- Last updated
- 12 Apr 2023
- 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Molecular Residual Disease Monitoring Based on ctDNA in Borderline Resectable or Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05802394
- Acronym / sponsor ID
- MAP-03 / K3378-03
- Conditions
- Pancreatic Cancer, Locally Advanced
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 6 Apr 2023 (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 clinical trial is to explore the value of molecular residual disease (MRD) monitoring based on ctDNA in borderline resectable or locally advanced pancreatic cancer. The main questions it aims to answer are:
- prognostic value of baseline MRD;
- the role of MRD dynamic changes after treatment in guiding treatment. Peripheral blood derived from participants will be obtained for MRD test before conversion therapy initiation and at the first imaging assessment after chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRD-guided | Experimental | Drug: Later-line therapyPatients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will receive a later-line therapy. |
| Routine treatment | No intervention | –Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will continued their current therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with histologically confirmed borderline resectable or locally advanced pancreatic cancer;
- conversion therapy was planned;
- both sexes, age ≥18 years old;
- ECOG performance status score ≤2;
- the expected survival time was ≥3 months.
Key exclusion criteria (4 listed)
- a known diagnosis of pancreatic cancer other than ductal adenocarcinoma;
- treated with any systemic antitumor treatment before first-line chemotherapy onset;
- died or lost to follow-up within one month after the initiation of first-line chemotherpay;
- combined with other primary malignances.
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 |
|---|---|---|
| Later-line therapyAnother chemotherapy regimen, targeted therapy, or immunotherapy | Drug | MRD-guided |
Primary outcome
Resection rate
Time frame: Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)
Proportion of patients who receive surgical resection
4 secondary outcomes
Overall survival
Time frame: Baseline until PD or death, whichever occurs first (up to approximately 24 months)
Progression-free survival
Time frame: Baseline until PD or death, whichever occurs first (up to approximately 24 months)
R0 resection rate
Time frame: Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)
Major pathological response
Time frame: Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)
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 12 Apr 2023.
- 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.
Chunmei Bai, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Later-line therapy in people with Pancreatic Cancer and Locally Advanced, run by Peking Union Medical College Hospital 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 5 inclusion and 4 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 12 Apr 2023. 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 Chunmei Bai, MD (010-69158764 ext. +86, tangh160706@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resection rate (time frame: Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)). 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 12 Apr 2023.