Local treatment for liver metastases in colorectal cancer patients

Analysis of the Efficacy of Local Liver Treatment for Multi-organ Colorectal Cancer Metastases: A Prospective, Multicenter, Non-randomized Concurrent Controlled Study

This study tests if combining local treatment for liver tumors with regular cancer therapy can help people with colorectal cancer live longer and feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Anhui Provincial Hospital (Government)
• Locations: 6 sites (Chuzhou, Anhui and 5 other locations)
• Trial ID: NCT06449937 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with resectable liver metastases from colorectal cancer and controllable extrahepatic metastases.

Not a fit: Patients with non-resectable liver metastases or uncontrolled extrahepatic metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with metastatic colorectal cancer.

How similar studies have performed: Other studies have shown promising results with local treatments for liver metastases, suggesting potential for success in this approach.

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.

Where this trial is running

Chuzhou, Anhui and 5 other locations

• 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

Conditions Metastatic Colorectal Carcinoma; Multi-organ Metastatic Colorectal Cancer; Metastatic Malignant Neoplasm in the Liver