Clinical trial NCT06449937: Local Liver Treatment for Multi-organ Colorectal Cancer Metastases
Official title: Analysis of the Efficacy of Local Liver Treatment for Multi-organ Colorectal Cancer Metastases: A Prospective, Multicenter, Non-randomized Concurrent Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Colorectal Carcinoma
Multi-organ Metastatic Colorectal Cancer
Metastatic Malignant Neoplasm in the Liver
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
Collaborators: name: First Affiliated Hospital of Wannan Medical College
First posted: 2024-06-10
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Primary objective:

1.To determine the survival benefit of local radical resection of liver metastases in patients with resectable liver and controllable extrahepatic metastases from colorectal cancer.

Secondary objectives:

1. To explore the prognosis-related risk factors in patients with colorectal cancer liver metastases combined with extrahepatic metastases
2. To assess patients' quality-of-life in each treatment group with questionnaires.
3. To evaluate the safety of the treatment in each treatment group.

Grouping Method: Patients are assigned to 1 of 2 groups according to their willingness.

GROUP I: Patients undergo radical local treatment of liver metastases (hepatectomy, ablation) combined with systemic therapy.

GROUP II: Patients receive Systemic therapy only or combined local interventions (TACE, HAIC)

Patients are followed up every 3 months up to 2 years.

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.

Primary outcomes:
measure: Overall survival
timeFrame: From date of study inclusion until the date of death or or the date of last follow-up, assessed up to 2 years
Secondary outcomes:
measure: Liver-specific progression free survival rates
timeFrame: Date of study inclusion to until local recurrence or progression in the liver or death from any cause, assessed up to 2 years
measure: Incidence of adverse events
timeFrame: Assessed up to 2 years
measure: Quality of life scores-EORTC QLQ-C30 (version 3) questionnaire
timeFrame: Assessed up to 2 years
Other outcomes:
Locations:
city: Chuzhou
country: China
facility: The First People's Hospital of Chu Zhou
state: Anhui
city: Fuyang
country: China
facility: Fuyang Cancer Hospital
state: Anhui
city: Hefei
country: China
facility: Anhui province hospital
state: Anhui
city: Ma'anshan
country: China
facility: Ma'anshan People's Hospital
state: Anhui
city: Wuhu
country: China
facility: The First Affiliated Hospital of Wannan Medical College
state: Anhui
city: Wuhu
country: China
facility: The Second People's Hospital of Wuhu
state: Anhui
Study officials:
affiliation: Anhui province hospital
name: Ji-Zhou Wang, MD PhD
role: STUDY_DIRECTOR
affiliation: First Affiliated Hospital of Wannan Medical College
name: Xiao-Ming Wang, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second People&amp;amp;#39;s Hospital of Wuhu
name: Yu-Zhi Hu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ma&amp;amp;#39;anshan People&amp;amp;#39;s Hospital
name: Yi-Ming Cao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First People&amp;amp;#39;s Hospital of Chu Zhou
name: Qing-Song Yang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fuyang Cancer Hospital
name: Si-Hua Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: