Actively Recruiting
Effect of Surgical Margin Width on Recurrence and Survival in Patients With Hepatic Oligometastasis of Colorectal Cancer
Led by Fudan University · Updated on 2025-05-06
140
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main objective of this study was to evaluate the effect of surgical margin width on the prognosis of patients with hepatic oligometastasis of colorectal cancer by statistical 1-year intrahepatic recurrence-free survival rate (ihRFSrate). The secondary objective of the study was to evaluate the effect of surgical margin width on long-term survival and total recurrence of colorectal cancer in patients with hepatohepatic metastasis by statistical overall survival time (OS) and relapse-free survival time (RFS), and to evaluate the safety of wide margin surgery compared with narrow margin surgery in patients with Cromitis during perioperative period. This was a single-center, prospective, randomized controlled clinical study to evaluate the effects of surgical margin width on 1-year intrahepatic relapse-free survival, relapse-free survival time, overall survival time, and perioperative safety in patients with hepatic oligometastasis of colorectal cancer. Subjects will undergo radical resection of liver tumors and will be randomly assigned to a wide margin group (≥7mm) or narrow margin group (\<7mm) using stratified randomization, stratified by primary lesion site (right colon vs left colon/rectum). The margin width was the narrowest margin distance measured in fresh specimens. After radical liver tumor resection, subjects were pretreated regularly Follow-up evaluation.
CONDITIONS
Official Title
Effect of Surgical Margin Width on Recurrence and Survival in Patients With Hepatic Oligometastasis of Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients, age 518 years
- ECOG Physical condition score 0-1
- Diagnosis of colorectal cancer with liver metastases confirmed by biopsy or clinical history with lab and imaging
- Primary colorectal cancer tumor has been or will be removed 4-6 weeks after liver surgery
- Five or fewer liver metastases
- No untreated extrahepatic metastases or any have been completely removed
- Preoperative imaging and assessment allow complete tumor removal with planned wide surgical margin 8 mm
- Good liver function (Child-Pugh grade A) and estimated liver volume 8 30%
- No clear surgical contraindications on preoperative exams
- Willing to participate and sign informed consent
- Good compliance and family support for follow-up
You will not qualify if you...
- Untreated extra-hepatic metastases
- Planned staged liver surgery like PVE combined with hepatectomy or ALPPS
- More than 5 liver metastases before chemotherapy
- Portal vein tumor thrombus or hepatic vein invasion
- Other uncured cancers or other primary cancers within past 5 years
- Expected survival less than 6 months
- History of psychotropic substance abuse or mental disorders preventing abstinence
- History of immunodeficiency or autoimmune disease
- Serious other diseases risking patient safety or study completion
- Patient or family unable to understand study conditions and goals
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200062
Actively Recruiting
Research Team
L
Lu Wang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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