Local treatment for liver metastases in colorectal cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of local radical treatment of liver metastases combined with systemic therapy in patients with multi-organ metastatic colorectal cancer. The primary objective is to determine if this approach improves survival for patients with resectable liver metastases and controllable extrahepatic metastases. Secondary objectives include exploring risk factors related to prognosis, assessing quality of life, and evaluating treatment safety. Patients are divided into two groups: one receiving local radical treatment and systemic therapy, and the other receiving systemic therapy alone or with different local interventions.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Principal investigator: Xiao-Ming Wang, MD PhD — First Affiliated Hospital of Wannan Medical College
• Study coordinator: Ji-Zhou Wang, MD PhD
• Email: wangjoe@ustc.edu.cn
• Phone: +86 13836135864

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.