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Local Liver Treatment for Multi-organ Colorectal Cancer Metastases

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About this study

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.

Condition
Metastatic Colorectal Carcinoma, Multi-organ Metastatic Colorectal Cancer, Metastatic Malignant Neoplasm in the Liver
Tested
Radical local Surgery, Systemic therapy, Interventional therapy
Sponsor
Anhui Provincial Hospital

Who can join

Age
18 to 80 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 22

  • Minimum age: 18 years
  • Maximum age: 80 years
  • Study condition: Metastatic Colorectal Carcinoma, Multi-organ Metastatic Colorectal Cancer, Metastatic Malignant Neoplasm in the Liver
  • 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 16

  • 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.

Where

6 sites, 6 recruiting

The First People's Hospital of Chu Zhou

Chuzhou, Anhui, China

Recruiting

Fuyang Cancer Hospital

Fuyang, Anhui, China

Recruiting

Anhui province hospital

Hefei, Anhui, China

Recruiting

Ma'anshan People's Hospital

Ma’anshan, Anhui, China

Recruiting

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Recruiting

The Second People's Hospital of Wuhu

Wuhu, Anhui, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.