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Starting soon Not applicable

Anatomical Resection VS. Nonanatomical Resection for Colorectal Liver Metastases With Gene Mutation or Right-sidedness

NCT05881746 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2023-07-01
Last updated
2023-05-31

Condition(s) studied

Colorectal CarcinomaLiver Metastases

Investigational drug(s) / intervention(s)

anatomical liver resectionnonanatomical liver resection

anatomical liver resection: Based upon the segmental anatomy of the liver according to Couinaud system, anatomical resection (AR) was defined as resection of 1 or more complete hepatic segments in our study, including bisegmentectomy, right hemihepatectomy, left hemihepatectomy, extended right hemihepatectomy, extended left hemihepatectomy, single segmentectomy, caudate lobectomy, or a combination of these.

nonanatomical liver resection: Nonanatomical resection(NAR), known as wedge resection, was defined as resection of the tumor with a margin of normal parenchyma without regard to hepatic anatomy.

Study summary

In this study, colorectal cancer patients with initially resectable liver-only metastases, as prospectively confirmed by a local multidisciplinary team (MDT) according to predefined criteria, will be tested for RAS and BRAF tumor mutation status. Patients with gene mutant or right-sidedness will be randomised between anatomical resection (AR) or nonanatomical resection (NAR). The primary end-point is the relapse-free survival.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 and ≤ 75 years; 2. Histological proof of colorectal adenocarcinoma; 3. Resectable colorectal liver metastasis without detectable extrahepatic distant metastatic disease (determined by a local MDT); 4. Suitable for anatomical or nonanatomical liver resection (determined by a local MDT); 5. Number of metastasis is 1 to 3; 6. KRAS/NRAS/BRAF mutation or right-sidedness; 7. Performance Status (ECOG) 0\~1; 8. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization); 9. Adequate liver and renal function: total bilirubin ≤2.0 mg/dl, serum transaminases ≤ 5x upper limit of normal(ULN), and serum creatinine ≤ 1.5x ULN and creatinine clearance ≥ 30 ml/min; 10. Written informed consent. Exclusion Criteria: 1. Previous systemic treatment for metastatic disease; 2. Previous surgery for metastatic disease; 3. Extrahepatic metastases; 4. Unresectable primary tumor; 5. Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months before randomisation; 6. Second primary malignancy within the past 5 years; 7. Acute or subacute intestinal obstruction; 8. Drug or alcohol abuse; 9. No legal capacity or limited legal capacity; 10. Pregnant or lactating women.

Primary outcome measure(s)

  • relapse-free survival — 3 years
    The relapse-free survival (PFS) was defined as the period from the start of initial liver resection to the date of tumor relapse or death

Trial sites (1)

FacilityCityRegionStatus
Zhongshan hospital Shanghai Shanghai Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05881746 on ClinicalTrials.gov ↗ ← All trials in China