Pancreatic CancerPCLM:CSSGNCT06873178
The Significance and Indications of Surgery for Synchronous Liver Metastatic Pancreatic Cancer
An observational study of Pancreatic Cancer and Liver Metastases, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
To explore the clinical characteristics of pancreatic cancer patients with liver metastases who can benefit from surgery, and to develop evaluation criteria for surgical indications, so as to provide basis for comprehensive treatment strategies for advanced pancreatic cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer, Liver Metastases, Surgery
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2024to 30 Jun 2026
- How long will I take part?
- 2 Years
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hospital
Who may be able to join
- Age 18-75 years old
- Pancreatic cancer was diagnosed as pancreatic ductal adenocarcinoma by biopsy of primary/metastases
- Physical Condition Score (ECOG)0-1
- Simultaneous/prior discovery of liver metastases and primary lesions was defined as simultaneous liver metastases
- Enhanced CT/MRI can detect liver metastases (if the diseases not detected by enhanced CT/MRI during screening are not included in the number calculation)
- The patient's liver, kidney and bone marrow function is good
Who cannot join
- The primary lesions of pancreatic cancer are acinar cell carcinoma of pancreas, neuroendocrine carcinoma of pancreas and other pathological types
- there are other metastases outside the liver
- Had other malignant tumors within 5 years
- History of central nervous system disease, mental illness, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases
- Active or chronic hepatitis B/C virus infection
- Allergy to iodine, unable to perform enhanced imaging
- Previous anti-tumor therapy for pancreatic cancer (surgery/ radiotherapy/ chemotherapy/ ablation/ targeted therapy/ immunotherapy)
Trial locations and contacts
1 site in 1 country.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: Liver Metastasis of Pancreatic Cancer：Chinese Surgical Study Group
To explore the clinical characteristics of pancreatic cancer patients with liver metastases who can benefit from surgery, and to develop evaluation criteria for surgical indications, so as to provide basis for comprehensive treatment strategies for advanced pancreatic cancer patients.
Read the detailed description
Initial Systemic Treatment: Subjects who meet the inclusion criteria will first undergo systemic treatment. The primary treatment regimens will follow the NCCN guideline-recommended first-line chemotherapy options, including the AG regimen, FOLFIRINOX regimen, and the NALIRIFOX regimen.
Periodic Assessments: Every 4 treatment cycles, laboratory tests (including blood routine, coagulation function, liver and kidney function, and tumor markers) and imaging studies (enhanced CT or MRI, with PET-CT if necessary) will be conducted. After 4-6 cycles, imaging and tumor marker assessments will be performed to evaluate the patient's disease status. A multidisciplinary discussion will determine if patients with a good response to systemic treatment are eligible for radical surgery.
Treatment Adjustment and Surgical Intervention: For patients assessed as having disease progression during the first evaluation, the treatment plan will be adjusted, and assessments will be conducted every 2 cycles. Patients showing a good response may still be considered for radical surgery. For pancreatic lesions, surgical procedures such as pancreaticoduodenectomy or distal pancreatectomy with splenectomy will be performed based on the lesion's location, with total pancreatectomy considered if necessary. For liver lesions, the surgical approach will depend on the number, size, and location of the lesions. During surgery, tumor and adjacent tissue samples (approximately 100mg, the size of a soybean) will be collected for research purposes, provided it does not affect diagnosis. Postoperative discarded specimens (approximately 500mg) will also be collected and preserved.
Postoperative Monitoring: Laboratory tests, including but not limited to blood routine, coagulation, liver, kidney, and pancreatic function, will be collected on postoperative days 1, 3, 5, 7, and 30.
Adjuvant Treatment and Complication Monitoring: Postoperative adjuvant treatment will continue according to the original regimen. Any postoperative complications and adverse reactions during chemotherapy will be recorded.
Trial Progress Tracking: The progress of each subject will be documented. If a subject withdraws or drops out, the reason and the date of the last medication will be recorded.
Follow-Up: After the completion of treatment, patients will be followed up monthly until death.
- Conditions
- Pancreatic Cancer, Liver Metastases, Surgery, Adjuvant 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 |
|---|---|---|
| retrospective | Retrospectively collect cases of pancreatic cancer with synchronous liver metastasis treated and analyze the preliminary results. | |
| foresight | On the basis of retrospective studies, a prospective clinical study is conducted. Through the prospective study of the outcomes of systemic treatment for patients with pancreatic cancer liver metastasis and the clinical results of surgical treatment after the effectiveness of systemic treatment, a basis is provided for the diagnosis and treatment strategies of pancreatic cancer liver metastasis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Overall Survival
Measured: through study completion, an average of 2 year
Secondary outcomes (1)
RFS
Recurrence free survival
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start23 Aug 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (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 China-Japan Friendship 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
- Other
- Enrolment
- 50 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, Chongqing General Hospital, Tongji Hospital, Zhejiang Provincial People's Hospital
- Responsible party
- Principal investigator, Zhiying Yang, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873178
- Sponsor's protocol ID
- 2024-KY-385-2
- Other IDs
- MR-11-25-016581
- Acronym
- PCLM:CSSG
- Status last verified
- Aug 2024
- First submitted
- 2 Mar 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Metastasis of Pancreatic Cancer：Chinese Surgical Study Group
- ClinicalTrials.gov ID
- NCT06873178
- Acronym / sponsor ID
- PCLM:CSSG / 2024-KY-385-2
- Conditions
- Pancreatic Cancer, Liver Metastases, Surgery, Adjuvant Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Collaborators
- Peking University First Hospital, Chongqing General Hospital, Tongji Hospital, Zhejiang Provincial People's Hospital
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 12 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.
To explore the clinical characteristics of pancreatic cancer patients with liver metastases who can benefit from surgery, and to develop evaluation criteria for surgical indications, so as to provide basis for comprehensive treatment strategies for advanced pancreatic cancer patients.
Detailed description
Initial Systemic Treatment: Subjects who meet the inclusion criteria will first undergo systemic treatment. The primary treatment regimens will follow the NCCN guideline-recommended first-line chemotherapy options, including the AG regimen, FOLFIRINOX regimen, and the NALIRIFOX regimen.
Periodic Assessments: Every 4 treatment cycles, laboratory tests (including blood routine, coagulation function, liver and kidney function, and tumor markers) and imaging studies (enhanced CT or MRI, with PET-CT if necessary) will be conducted. After 4-6 cycles, imaging and tumor marker assessments will be performed to evaluate the patient's disease status. A multidisciplinary discussion will determine if patients with a good response to systemic treatment are eligible for radical surgery.
Treatment Adjustment and Surgical Intervention: For patients assessed as having disease progression during the first evaluation, the treatment plan will be adjusted, and assessments will be conducted every 2 cycles. Patients showing a good response may still be considered for radical surgery. For pancreatic lesions, surgical procedures such as pancreaticoduodenectomy or distal pancreatectomy with splenectomy will be performed based on the lesion's location, with total pancreatectomy considered if necessary. For liver lesions, the surgical approach will depend on the number, size, and location of the lesions. During surgery, tumor and adjacent tissue samples (approximately 100mg, the size of a soybean) will be collected for research purposes, provided it does not affect diagnosis. Postoperative discarded specimens (approximately 500mg) will also be collected and preserved.
Postoperative Monitoring: Laboratory tests, including but not limited to blood routine, coagulation, liver, kidney, and pancreatic function, will be collected on postoperative days 1, 3, 5, 7, and 30.
Adjuvant Treatment and Complication Monitoring: Postoperative adjuvant treatment will continue according to the original regimen. Any postoperative complications and adverse reactions during chemotherapy will be recorded.
Trial Progress Tracking: The progress of each subject will be documented. If a subject withdraws or drops out, the reason and the date of the last medication will be recorded.
Follow-Up: After the completion of treatment, patients will be followed up monthly until death.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| retrospective | – | –Retrospectively collect cases of pancreatic cancer with synchronous liver metastasis treated and analyze the preliminary results. |
| foresight | – | –On the basis of retrospective studies, a prospective clinical study is conducted. Through the prospective study of the outcomes of systemic treatment for patients with pancreatic cancer liver metastasis and the clinical results of surgical treatment after the effectiveness of systemic treatment, a basis is provided for the diagnosis and treatment strategies of pancreatic cancer liver metastasis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospital
Key inclusion criteria (6 listed)
- Age 18-75 years old
- Pancreatic cancer was diagnosed as pancreatic ductal adenocarcinoma by biopsy of primary/metastases
- Physical Condition Score (ECOG)0-1
- Simultaneous/prior discovery of liver metastases and primary lesions was defined as simultaneous liver metastases
- Enhanced CT/MRI can detect liver metastases (if the diseases not detected by enhanced CT/MRI during screening are not included in the number calculation)
Key exclusion criteria (7 listed)
- The primary lesions of pancreatic cancer are acinar cell carcinoma of pancreas, neuroendocrine carcinoma of pancreas and other pathological types
- there are other metastases outside the liver
- Had other malignant tumors within 5 years
- History of central nervous system disease, mental illness, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases
- Active or chronic hepatitis B/C virus infection
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
OS
Time frame: through study completion, an average of 2 year
Overall Survival
1 secondary outcome
RFS
Time frame: through study completion, an average of 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 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 Pancreatic Cancer and Liver Metastases, run by China-Japan Friendship 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 16 Apr 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?
Results are not available in the source record.
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?
OS (time frame: through study completion, an average of 2 year). 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 16 Apr 2025.