RecruitingNot ApplicableNCT06449937
Local Liver Treatment for Multi-organ Colorectal Cancer Metastases
Analysis of the Efficacy of Local Liver Treatment for Multi-organ Colorectal Cancer Metastases: A Prospective, Multicenter, Non-randomized Concurrent Controlled Study
Sponsor
Anhui Provincial Hospital
Enrollment
130 participants
Start Date
Jul 1, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria19
- 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) ≥ 1.5×10\^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\> 50 ml/min;
- Albumin \> 30 g/l.
Exclusion Criteria16
- Patients with only liver metastasis confirmed by CT or MRI.
- History of hepatic encephalopathy or liver transplantation.
- Evidence of brain metastases.
- Pregnant or breast-feeding women.
- History of other malignant tumors (except thyroid cancer and carcinoma in situ) can be included in the study if the individual has remained disease-free for at least 5 years.
- Patients with acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction and acute coronary syndrome within 1 month, and the cardiovascular clinical symptoms or diseases were not well controlled.
- NYHA class 3-4 or left ventricular ejection fraction (LVEF) \< 50 % by echocardiography.
- Uncontrollable hypertension, blood pressure \> 160 / 95 mmHg after treatment, history of hypertensive crisis or hypertensive encephalopathy.
- Uncontrollable infection \> grade 2 (NCI-CTC version 5.0).
- Patients with respiratory insufficiency : PaO2 \< 60 mmHg at rest , with or without PaCO2 \> 50 mmHg.
- Patients with a large amount of ascites (ultrasound examination showed an echoless area around the liver and spleen, pelvic cavity, and intestinal loops, and the mesentery and intestinal canal were seen floating in the echoless area ) or malignant ascites (cancer cells were found in ascites or ascites CEA was higher than peripheral blood).
- Coagulation dysfunction ( INR \> 1.5 or APTT \> 1.5\*ULN ), with bleeding tendency.
- Long-term unhealed wounds or fractures, major surgery or severe traumatic injury, fracture or ulcer occurred within 4 weeks.
- Patients with a history of mental drug abuse and who could not quit or had mental disorders.
- According to the investigator's judgment, patients with concomitant diseases that seriously endanger patient safety or affect patient completion of the study.
- According to the investigator's judgment, patients who are not suitable for inclusion.
Interventions
PROCEDURERadical local Surgery
Radical local resection of liver metastases ( hepatectomy, ablation )
DRUGSystemic therapy
Chemotherapy, targeted drug therapy, immunotherapy treatment.
OTHERInterventional therapy
Transcatheter arterial chemoembolization (TACE) Hepatic arterial infusion chemotherapy (HAIC)
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT06449937
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