The Significance and Indications of Surgery for Synchronous Liver Metastatic Pancreatic Cancer

NCT06873178 | Active Not Recruiting

• 2 other identifiers: 2024-KY-385-2MR-11-25-016581
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer; Liver Metastases; Surgery; Adjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• OS

  Overall Survival

  through study completion, an average of 2 year

Secondary Outcomes (1)

• RFS

  through study completion, an average of 2 year

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

hospital

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead
• Peking University First Hospital: collaborator
• Chongqing General Hospital: collaborator
• Tongji Hospital: collaborator
• Zhejiang Provincial People's Hospital: collaborator

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Hepatobiliary and Pancreatic Surgery, Clinical Professor

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: March 12, 2025
• Study Start: August 23, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 16, 2025

Record last verified: 2024-08

Locations

CN (1)