Local Liver Treatment for Multi-organ Colorectal Cancer Metastases (NCT06449937) | Clinical Trial Compass
RecruitingNot Applicable
Local Liver Treatment for Multi-organ Colorectal Cancer Metastases
China130 participantsStarted 2024-07
Plain-language summary
The purpose of this study was to investigate the effect of only local radical treatment of liver metastases combined with systematic treatment in the treatment of patients with multiple organ metastases of colorectal cancer, whether it can benefit the prognosis and explore the risk factors related to the prognosis.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Male or female, 18-80 years of age.
* Patients volunteered to join the study and signed informed consent, with good compliance and follow-up.
* Primary colorectal tumors can be radically resected or resected and histopathologically diagnosed as colorectal cancer.
* Patients with synchronous or metachronous diagnosis of liver metastasis and extrahepatic metastasis by computed tomography (CT) or magnetic resonance imaging (MRI).Extrahepatic metastases are stable and controllable as determined by Multi-disciplinary Treatment (MDT).
* Patients receive only first- or second-line systemic therapy.
* Radical local treatment can be performed after MDT evaluation, and the indications at least meet the following one:
* Hepatectomy: liver metastases can be completely (R0) removed and required to retain sufficient functional liver tissue;
* Ablation therapy: The maximum diameter of liver metastases\<3 cm, and the maximum number of ablation ≤ 5.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Life expectancy of at least 3 months.
* Child-Pugh score ≤ 7.
* Laboratory routine examination (blood routine, liver and kidney function, coagulation function, etc.) no significant abnormalities:
* Absolute neutrophil count (ANC) ≥ 1.5Ă—10\^9/l;
* Platelet count (PLT) ≥ 100\*10\^9/l;
* Hemoglobin ≥ 9g/dl;
* TBIL\<1.5 times the upper limit of normal (ULN);
* ALT and AST\< 5\*ULN;
* Serum creatinine ≤ 1.5 \* ULN or Creatinine clearance\> …
What they're measuring
1
Overall survival
Timeframe: From date of study inclusion until the date of death or or the date of last follow-up, assessed up to 2 years