Local Liver Treatment for Multi-organ Colorectal Cancer Metastases

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

Study Overview

• Status: Recruiting
• Conditions: Metastatic Malignant Neoplasm in the Liver; Metastatic Colorectal Carcinoma; Multi-organ Metastatic Colorectal Cancer
• Intervention / Treatment: Procedure: Radical local Surgery; Drug: Systemic therapy; Other: Interventional therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ji-Zhou Wang, MD PhD; Phone Number: +86 13836135864; Email: wangjoe@ustc.edu.cn

Study Locations

• China
  • Anhui
    • Chuzhou, Anhui, China, 233100
      • Recruiting
      • The First People's Hospital of Chu Zhou
      • Contact: Qing-Song Yang, MD; Phone Number: +86 13637045768; Email: yanchen091106@163.com
    • Fuyang, Anhui, China, 236000
      • Recruiting
      • Fuyang Cancer Hospital
      • Contact: Si-Hua Wu, MD; Phone Number: +86 13965560586; Email: wangjoe@ustc.edu.cn
    • Hefei, Anhui, China, 230000
      • Recruiting
      • Anhui Province Hospital
      • Contact: Ji-Zhou Wang, MD PhD; Phone Number: 13836135864; Email: wangjoe@ustc.edu.cn
    • Ma'anshan, Anhui, China, 243000
      • Recruiting
      • Ma'anshan People's Hospital
      • Contact: Yi-Ming Cao, MD; Phone Number: +86 13955577008; Email: 79493183@qq.com
    • Wuhu, Anhui, China, 241000
      • Recruiting
      • The First Affiliated Hospital of Wannan Medical College
      • Contact: Xiao-Ming Wang, MD,PhD; Phone Number: +86 15922312712; Email: wxm6901@aliyun.com
    • Wuhu, Anhui, China, 241000
      • Recruiting
      • The Second People's Hospital of WuHu
      • Contact: Yu-Zhi Hu, MD; Phone Number: +86 18055316877; Email: wangjoe@ustc.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (Radical local treatment combined with systematic treatment); Patients undergo radical local treatment of liver metastases (hepatectomy, ablation) combined with systematic treatment.	Procedure: Radical local Surgery; Radical local resection of liver metastases ( hepatectomy, ablation ); Drug: Systemic therapy; Chemotherapy, targeted drug therapy, immunotherapy treatment.; Other Names: Targeted therapy; Chemotherapy, Cancer, General; immunotherapy
Active Comparator: Group II (systematic treatment only or combined with local interventional therapy); Patients undergo systemic therapy only or combined with local interventional therapy (TACE, HAIC).	Drug: Systemic therapy; Chemotherapy, targeted drug therapy, immunotherapy treatment.; Other Names: Targeted therapy; Chemotherapy, Cancer, General; immunotherapy; Other: Interventional therapy; Transcatheter arterial chemoembolization (TACE) Hepatic arterial infusion chemotherapy (HAIC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Differences in overall survival between the two arms were assessed using the log-rank test; Cox proportional hazards regression models were used to determine the factors and hazard ratios associated with overall survival.	From date of study inclusion until the date of death or or the date of last follow-up, assessed up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver-specific progression free survival rates	The Kaplan-Meier method will be used to estimate time to intrahepatic recurrence or progression or death from any cause in patients.	Date of study inclusion to until local recurrence or progression in the liver or death from any cause, assessed up to 2 years
Incidence of adverse events	Record the frequency and percentage of adverse events, their grade, and their relationship to radical local treatment.	Assessed up to 2 years
Quality of life scores-EORTC QLQ-C30 (version 3) questionnaire	Summarized using descriptive statistics, including mean, standard deviation, median and range.	Assessed up to 2 years

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital
• Collaborators: First Affiliated Hospital of Wannan Medical College
• Investigators: Study Director: Ji-Zhou Wang, MD PhD, Anhui Province Hospital; Principal Investigator: Xiao-Ming Wang, MD PhD, The First Affiliated Hospital of Wannan Medical College; Principal Investigator: Yu-Zhi Hu, MD, The Second People&#39;s Hospital of Wuhu; Principal Investigator: Yi-Ming Cao, MD, Ma&#39;anshan People&#39;s Hospital; Principal Investigator: Qing-Song Yang, MD, The First People&#39;s Hospital of Chu Zhou; Principal Investigator: Si-Hua Wu, MD, Fuyang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplasms; Colorectal Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Immunomodulating Agents
• Other Study ID Numbers: 2024KY109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No