The Significance and Indications of Surgery for Synchronous Liver Metastatic Pancreatic Cancer
NCT ID: NCT06873178
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
50 participants
OBSERVATIONAL
2024-08-23
2026-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
OTHER
Study Groups
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retrospective
Retrospectively collect cases of pancreatic cancer with synchronous liver metastasis treated and analyze the preliminary results.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
75 Years
ALL
No
Sponsors
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Peking University First Hospital
OTHER
Chongqing General Hospital
OTHER
Tongji Hospital
OTHER
Zhejiang Provincial People's Hospital
OTHER
China-Japan Friendship Hospital
OTHER
Responsible Party
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Zhiying Yang
Director, Head of Hepatobiliary and Pancreatic Surgery, Clinical Professor
Locations
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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MR-11-25-016581
Identifier Type: OTHER
Identifier Source: secondary_id
2024-KY-385-2
Identifier Type: -
Identifier Source: org_study_id
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