Metastatic Pancreatic CancerNCT06967233
Multimodal Managements for Metastatic Pancreatic Cancer.
An observational study of Metastatic Pancreatic Cancer, run by Zhejiang University at 1 site in China.
Trial summary
Pancreatic ductal adenocarcinoma (PDAC) remains a challenging malignancy, with over 300,000 patients diagnosed annually worldwide. Patients with metastatic pancreatic cancer (MPC) are generally not considered appropriate for operative management because it would not improve their prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- Multimodal treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: All patients were cytologically or histologically diagnosed with pancreatic cancer, as well as with the primary tumor and liver metastasis. The primary and metastatic lesions were determined using CT and MRI.
Who may be able to join
- Adult patients aged ≥18 years (at diagnosis).
- Cytologically or histologically confirmed pancreatic adenocarcinoma.
- Synchronous liver metastatic disease (at diagnosis).
- No evidence of extrahepatic metastases (at diagnosis.)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
- Eligible for multimodal treatment.
Who cannot join
- Multi-organ metastatic pancreatic cancer.
- Contraindications to surgical resection or systemic treatment.
- Inability to participate in follow-up assessments.
- History of other malignancies.
- Refusal of treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital, Zhejiang university school of medicine
Hangzhou, Zhejiang, 310000
About this study
Official title: Analysis of the Current Situation of Diagnosis and Treatment of Pancreatic Cancer: Multimodal Managements for Metastatic Pancreatic Cancer
Pancreatic ductal adenocarcinoma (PDAC) remains a challenging malignancy, with over 300,000 patients diagnosed annually worldwide. Patients with metastatic pancreatic cancer (MPC) are generally not considered appropriate for operative management because it would not improve their prognosis.
Developments in modern surgery and systemic treatment over the past decade have substantially improved the oncological outcomes for patients with PDAC. The prognosis can be further improved by using novel combined regimens. Systemic treatment is advantageous as it allows biological selection of patients and control of systemic lesions in patients with PDAC with only hepatic metastases (Hep-MPC), which may increase the likelihood of radical tumor resection and improved survival. Therefore, there is a strong need to reassess the value of surgery in Hep-MPC.
Read more
Locoregional liver-directed treatments (LLDTs) are safe and efficient methodologies and have thus become the standard of care for patients with metastatic colorectal cancer (MCC) with liver-only or liver-dominant metastases. LLDT therapies include local liver resection, radiofrequency ablation (RFA), hepatic artery infusion pump chemotherapy (HAIP), stereotactic body radiation therapy (SBRT), and selective internal radiation therapy with yttrium-90 embolization (Y90). These therapies have been reported to influence the overall survival (OS), progression-free survival (PFS), and conversion to resection in patients with metastatic colorectal cancer. However, the data on the survival outcomes of conversion surgery and the clinical application of LLDT in Hep-MPC are sparse. Therefore, it remains unclear what types of treatment, based on the survival benefit, might actually be the optimal approach for Hep-MPC after effective systemic treatment.
The present study aims to clarify the selection criteria of conversion surgery for Hep-MPC and explore the prognostic significance for its multimodal management, including surgical resection and/or LLDT.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- Multimodal treatment
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal treatmentOther
Surgical resection, locoregional liver-directed treatments and continuous systemic treatment in patients with liver metastatic pancreatic cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Calculated from the date of treatment initiation to the date of death or the last date of follow-up
Measured: From the date of treatment initiation to the date of death or the last date of follow-up (up to 60 months)
Secondary outcomes (1)
Progression free survival
The duration between the date of treatment initiation and disease progression or death, whichever occurred first.
Measured: From the date of treatment initiation to the date of disease progression or death, whichever occurred first (up to 60 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Jun 2019
- Primary completion31 Dec 2023
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967233
- Sponsor's protocol ID
- Multimodal-MPC
- Status last verified
- May 2025
- First submitted
- 2 May 2025
- Last updated
- 13 May 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 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Current Situation of Diagnosis and Treatment of Pancreatic Cancer: Multimodal Managements for Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06967233
- Acronym / sponsor ID
- Multimodal-MPC
- Conditions
- Metastatic Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 13 May 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.
Pancreatic ductal adenocarcinoma (PDAC) remains a challenging malignancy, with over 300,000 patients diagnosed annually worldwide. Patients with metastatic pancreatic cancer (MPC) are generally not considered appropriate for operative management because it would not improve their prognosis.
Developments in modern surgery and systemic treatment over the past decade have substantially improved the oncological outcomes for patients with PDAC. The prognosis can be further improved by using novel combined regimens. Systemic treatment is advantageous as it allows biological selection of patients and control of systemic lesions in patients with PDAC with only hepatic metastases (Hep-MPC), which may increase the likelihood of radical tumor resection and improved survival. Therefore, there is a strong need to reassess the value of surgery in Hep-MPC.
Locoregional liver-directed treatments (LLDTs) are safe and efficient methodologies and have thus become the standard of care for patients with metastatic colorectal cancer (MCC) with liver-only or liver-dominant metastases. LLDT therapies include local liver resection, radiofrequency ablation (RFA), hepatic artery infusion pump chemotherapy (HAIP), stereotactic body radiation therapy (SBRT), and selective internal radiation therapy with yttrium-90 embolization (Y90). These therapies have been reported to influence the overall survival (OS), progression-free survival (PFS), and conversion to resection in patients with metastatic colorectal cancer. However, the data on the survival outcomes of conversion surgery and the clinical application of LLDT in Hep-MPC are sparse. Therefore, it remains unclear what types of treatment, based on the survival benefit, might actually be the optimal approach for Hep-MPC after effective systemic treatment.
The present study aims to clarify the selection criteria of conversion surgery for Hep-MPC and explore the prognostic significance for its multimodal management, including surgical resection and/or LLDT.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients were cytologically or histologically diagnosed with pancreatic cancer, as well as with the primary tumor and liver metastasis. The primary and metastatic lesions were determined using CT and MRI.
Key inclusion criteria (6 listed)
- Adult patients aged ≥18 years (at diagnosis).
- Cytologically or histologically confirmed pancreatic adenocarcinoma.
- Synchronous liver metastatic disease (at diagnosis).
- No evidence of extrahepatic metastases (at diagnosis.)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
Key exclusion criteria (5 listed)
- Multi-organ metastatic pancreatic cancer.
- Contraindications to surgical resection or systemic treatment.
- Inability to participate in follow-up assessments.
- History of other malignancies.
- Refusal of treatment.
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 |
|---|---|---|
| Multimodal treatmentSurgical resection, locoregional liver-directed treatments and continuous systemic treatment in patients with liver metastatic pancreatic cancer | Other | – |
Primary outcome
Overall survival
Time frame: From the date of treatment initiation to the date of death or the last date of follow-up (up to 60 months)
Calculated from the date of treatment initiation to the date of death or the last date of follow-up
1 secondary outcome
Progression free survival
Time frame: From the date of treatment initiation to the date of disease progression or death, whichever occurred first (up to 60 months).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
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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. 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?
An observational study of Metastatic Pancreatic Cancer, run by Zhejiang University 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 13 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall survival (time frame: From the date of treatment initiation to the date of death or the last date of follow-up (up to 60 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 13 May 2025.