The Role of Molecular Residual Disease in the Treatment Strategy and Prognosis Prediction of Pancreatic Cancer Patients Undergoing Adjuvant TherapyNCT06867146
MRD in PAAD Adjuvant Therapy
A study testing Three-drug chemotherapy group and two-drug chemotherapy group in people with The Role of Molecular Residual Disease in the Treatment Strategy and Prognosis Prediction of Pancreatic Cancer Patients Undergoing Adjuvant Therapy and Molecular Residual Disease, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Our preliminary research has explored the detection efficacy of minimal residual disease (MRD) in pancreatic cancer. In patients with pancreatic cancer undergoing dual-agent adjuvant chemotherapy, the median recurrence-free survival (RFS) is approximately 13.9 months. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- The Role of Molecular Residual Disease in the Treatment Strategy and Prognosis Prediction of Pancreatic Cancer Patients Undergoing Adjuvant Therapy, Molecular Residual Disease, Pancreatic Cancer
- What is being tested?
- Three-drug chemotherapy group and two-drug chemotherapy group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2024to 30 Dec 2027
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Here's the translated and polished version of your content:
- Patients clinically diagnosed with pancreatic cancer, staged I-III (AJCC V8.0), who are scheduled to undergo curative surgery.
- No restrictions on gender; age between 18 and 70 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score: ≤2.
- Expected survival time of ≥3 months.
- Willingness to comply with the study protocol for testing, treatment, and follow-up; consent to provide necessary clinical, pathological, and follow-up data for the study; and agreement to use the research data for future studies and product development.
- Voluntary participation in this clinical study, with an understanding of the study procedures and the ability to sign an informed consent form.
Who cannot join
- Patients who have had other malignancies within the five years prior to this study.
- Patients who have received any antitumor treatment within six months prior to enrollment.
- Patients with concomitant diseases that, in the investigator's judgment, pose a serious risk to patient safety or could affect the patient's ability to complete the study (such as poorly controlled hypertension, severe diabetes, thyroid disorders, psychiatric disorders, etc.), or any other conditions deemed unsuitable for participation.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: The Role of Molecular Residual Disease in the Treatment Strategy and Prognosis Prediction of Pancreatic Cancer Patients Undergoing Adjuvant Therapy
Our preliminary research has explored the detection efficacy of minimal residual disease (MRD) in pancreatic cancer. In patients with pancreatic cancer undergoing dual-agent adjuvant chemotherapy, the median recurrence-free survival (RFS) is approximately 13.9 months. Due to the high postoperative recurrence rate, short survival time, and intense systemic chemotherapy in pancreatic cancer patients, there is an urgent clinical need to more accurately identify which patients will benefit from adjuvant therapy. This study aims to evaluate the application value and guiding significance of peripheral blood MRD in the decision-making process for adjuvant treatment in patients with resected pancreatic cancer.
- Conditions
- The Role of Molecular Residual Disease in the Treatment Strategy and Prognosis Prediction of Pancreatic Cancer Patients Undergoing Adjuvant Therapy, Molecular Residual Disease, Pancreatic Cancer, Adjuvant Therapy
- Being tested
- Three-drug chemotherapy group, two-drug chemotherapy group
- Keywords
- pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-drug chemotherapy groupDrug
Three-drug chemotherapy group, mFOLFIRINOX, including 5-fluorouracil, leucovorin, oxaliplatin and irinotecan.
two-drug chemotherapy groupDrug
two-drug chemotherapy group, including gemcitabine-based combination regimens (predominately gemcitabine/nab-paclitaxel or gemcitabine/capecitabine)
| Study group | Role | What they receive |
|---|---|---|
| MRD postive | Sham comparator | Not described Receives: Drug: Three-drug chemotherapy group |
| MRD negative | Active comparator | Not described Receives: Drug: two-drug chemotherapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
DFS refers to the length of time after treatment during which a patient remains free of any signs or symptoms of the disease. It is primarily used in cancer research to measure the effectiveness of treatments in preventing recurrence. Median follow-up time up to 18 months
Measured: up to 18 months
Secondary outcomes (1)
OS
OS measures the length of time from either the diagnosis or the start of treatment to the death of the patient, regardless of cause. Median follow-up time up to 18 months.
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start15 Oct 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Role of Molecular Residual Disease in the Treatment Strategy and Prognosis Prediction of Pancreatic Cancer Patients Undergoing Adjuvant TherapyStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- For patients with pathological stage I pancreatic cancer, if they are baseline MRD-positive after surgery, or MRD-negative but have high-risk recurrence factors (including perineural invasion, lymphovascular invasion, preoperative CA19-9 \> 180 U/ml, postoperative CA19-9 \> 37 U/ml, or extrapancreatic tumor infiltration), they will receive standard dual-agent chemotherapy, such as gemcitabine combined with nab-paclitaxel or capecitabine, with the chemotherapy regimen selected by the clinical doctor. If the patient is baseline MRD-negative and has no high-risk recurrence factors, they will be randomly assigned in a 1:1 ratio to either receive standard chemotherapy or be observed. For patients with pathological stage II-III pancreatic cancer, if they are baseline MRD-negative after surgery, they will receive standard dual-agent chemotherapy, such as gemcitabine combined with nab-paclitaxel or capecitabine, with the chemotherapy regimen selected by the clinical doctor. If the patient is ba
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867146
- Sponsor's protocol ID
- K3378
- Status last verified
- Oct 2024
- First submitted
- 18 Nov 2024
- Last updated
- 10 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Molecular Residual Disease in the Treatment Strategy and Prognosis Prediction of Pancreatic Cancer Patients Undergoing Adjuvant Therapy
- ClinicalTrials.gov ID
- NCT06867146
- Acronym / sponsor ID
- K3378
- Conditions
- The Role of Molecular Residual Disease in the Treatment Strategy and Prognosis Prediction of Pancreatic Cancer Patients Undergoing Adjuvant Therapy, Molecular Residual Disease, Pancreatic Cancer, Adjuvant Therapy
- Keywords
- pancreatic cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 10 Mar 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.
Our preliminary research has explored the detection efficacy of minimal residual disease (MRD) in pancreatic cancer. In patients with pancreatic cancer undergoing dual-agent adjuvant chemotherapy, the median recurrence-free survival (RFS) is approximately 13.9 months. Due to the high postoperative recurrence rate, short survival time, and intense systemic chemotherapy in pancreatic cancer patients, there is an urgent clinical need to more accurately identify which patients will benefit from adjuvant therapy. This study aims to evaluate the application value and guiding significance of peripheral blood MRD in the decision-making process for adjuvant treatment in patients with resected pancreatic cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- For patients with pathological stage I pancreatic cancer, if they are baseline MRD-positive after surgery, or MRD-negative but have high-risk recurrence factors (including perineural invasion, lymphovascular invasion, preoperative CA19-9 > 180 U/ml, postoperative CA19-9 > 37 U/ml, or extrapancreatic tumor infiltration), they will receive standard dual-agent chemotherapy, such as gemcitabine combined with nab-paclitaxel or capecitabine, with the chemotherapy regimen selected by the clinical doctor. If the patient is baseline MRD-negative and has no high-risk recurrence factors, they will be randomly assigned in a 1:1 ratio to either receive standard chemotherapy or be observed. For patients with pathological stage II-III pancreatic cancer, if they are baseline MRD-negative after surgery, they will receive standard dual-agent chemotherapy, such as gemcitabine combined with nab-paclitaxel or capecitabine, with the chemotherapy regimen selected by the clinical doctor. If the patient is ba
| Arm | Type | Receives |
|---|---|---|
| MRD postive | Sham comparator | Drug: Three-drug chemotherapy group |
| MRD negative | Active comparator | Drug: two-drug chemotherapy group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Here's the translated and polished version of your content:
Key exclusion criteria (3 listed)
- Patients who have had other malignancies within the five years prior to this study.
- Patients who have received any antitumor treatment within six months prior to enrollment.
- Patients with concomitant diseases that, in the investigator's judgment, pose a serious risk to patient safety or could affect the patient's ability to complete the study (such as poorly controlled hypertension, severe diabetes, thyroid disorders, psychiatric disorders, etc.), or any other conditions deemed unsuitable for participation.
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 |
|---|---|---|
| Three-drug chemotherapy groupThree-drug chemotherapy group, mFOLFIRINOX, including 5-fluorouracil, leucovorin, oxaliplatin and irinotecan. | Drug | MRD postive |
| two-drug chemotherapy grouptwo-drug chemotherapy group, including gemcitabine-based combination regimens (predominately gemcitabine/nab-paclitaxel or gemcitabine/capecitabine) | Drug | MRD negative |
Primary outcome
DFS
Time frame: up to 18 months
DFS refers to the length of time after treatment during which a patient remains free of any signs or symptoms of the disease. It is primarily used in cancer research to measure the effectiveness of treatments in preventing recurrence. Median follow-up time up to 18 months
1 secondary outcome
OS
Time frame: up to 18 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 10 Mar 2025.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three-drug chemotherapy group and two-drug chemotherapy group in people with The Role of Molecular Residual Disease in the Treatment Strategy and Prognosis Prediction of Pancreatic Cancer Patients Undergoing Adjuvant Therapy and Molecular Residual Disease, 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 7 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 10 Mar 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (time frame: up to 18 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 10 Mar 2025.