Impact of surgical margin width on recurrence and survival in liver cancer from colorectal metastasis

Effect of Surgical Margin Width on Recurrence and Survival in Patients With Hepatic Oligometastasis of Colorectal Cancer

This study is testing whether having wider surgical margins during liver surgery for colorectal cancer spread can help patients live longer and have fewer recurrences of cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fudan University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06934018 on ClinicalTrials.gov

What this trial studies

This study evaluates how the width of surgical margins affects the prognosis of patients with hepatic oligometastasis from colorectal cancer. It is a single-center, prospective, randomized controlled trial that aims to assess the 1-year intrahepatic recurrence-free survival rate, overall survival time, and relapse-free survival time. Additionally, the study will compare the safety of wide margin surgery versus narrow margin surgery during the perioperative period. Patients will undergo radical resection of liver metastases, with careful preoperative assessments to ensure optimal surgical outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with hepatic oligometastasis from colorectal cancer and good liver function.

Not a fit: Patients with extrahepatic metastases or those who cannot undergo radical resection may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical strategies that enhance survival rates and reduce recurrence in patients with liver metastases from colorectal cancer.

How similar studies have performed: Previous studies have indicated that surgical margin width can significantly impact outcomes in cancer surgeries, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Male or female patients, age ≥18 years;
* ECOG Physical condition score :0-1 score;
* Liver biopsy pathologic diagnosis or clinical history combined with laboratory examination and imaging findings can be used to diagnose colorectal cancer in liver;
* The primary lesion of colorectal cancer has been resected or can be resected 4-6 weeks after hepatectomy;
* The number of liver metastases was less than or equal to 5；
* There was no extrahepatic metastases or the metastases were radically resected；
* Preoperative assessment (based on enhanced CT or MRI image AI segmentation combined with three-dimensional reconstruction of hepatic parenchymal blood vessels) enables radical (R0) resection of hepatic oligometastases, and wide surgical margin (the narrowest incisal margin of fresh specimens surgically removed is greater than or equal to 7mm) can be achieved technically, and the incisal margin width is not affected by the intrahepatic vasculature；
* Good liver reserve function (preoperative Child-Pugh grade A liver function, estimated remaining liver volume ≥30%)；
* Preoperative examinations do not show clear surgical contraindications；
* Volunteer to participate in this study and sign the informed consent；
* The compliance was good, and the family members were willing to cooperate with the follow-up；

Exclusion Criteria:

* There are still untreated extra-hepatic metastases；
* Staging hepatectomy is planned, such as PVE combined with hepatectomy, ALPPS, etc；
* The number of liver metastases before chemotherapy was more than 5；
* Complicated with portal vein tumor thrombus or hepatic vein invasion；
* Concurrent with other uncured malignancies or with other primary malignancies for less than 5 years；
* Expected survival time ≤6 months；
* Those who have a history of psychotropic substance abuse and are unable to abstain or have mental disorders；
* Have a history of immunodeficiency or other acquired or congenital immunodeficiency diseases; Or have an autoimmune disease；
* According to the study, there are serious concomitant diseases that endanger the patient's safety or interfere with the patient's completion of the study；
* Patients or family members could not understand the conditions and goals of the study；

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Lu Wang, PhD

Conditions: Oncology, Tumor Recurrence and Metastasis, Liver metastasis of colorectal cancer