Local Liver Treatment for Multi-organ Colorectal Cancer Metastases

Launched by ANHUI PROVINCIAL HOSPITAL · Jun 4, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how well local treatments for liver tumors can work when combined with other treatments for colorectal cancer that has spread to multiple organs. The goal is to see if this approach can improve patients' outlook and to identify factors that might affect their recovery.

To participate in the trial, patients need to be between 18 and 80 years old and have colorectal cancer that has spread to the liver and possibly other areas. They must be in good health overall and able to undergo specific local treatments, such as surgery to remove liver tumors or a procedure to destroy them, depending on the size and number of tumors. Patients who join the trial can expect close monitoring and support throughout their treatment. It's important to note that individuals with certain health issues, like severe heart problems or active infections, may not be eligible to participate.

Gender

ALL

Eligibility criteria

• 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) ≥ 1.5×10\^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 Criteria:
• • 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.