NCT06449937

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Radical local Surgery	Radical local resection of liver metastases ( hepatectomy, ablation )
DRUG	Systemic therapy	Chemotherapy, targeted drug therapy, immunotherapy treatment.
OTHER	Interventional therapy	Transcatheter arterial chemoembolization (TACE) Hepatic arterial infusion chemotherapy (HAIC)

Timeline

• Start date: 2024-07-01
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2024-06-10
• Last updated: 2024-06-10

Locations

6 sites across 1 country: China