NCT06177288

DEBIRI Combined With Chemotherapy and Bevacizumab in the Treatment of Unresectable Colorectal Cancer Liver Metastases

A Prospective, Single-arm Clinical Study on the Efficacy and Safety of DEBIRI Combined With Systemic Chemotherapy and Bevacizumab for Unresectable Colorectal Cancer With Liver Metastases

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To study the efficacy and safety of embolization therapy with uniform particle size drug-eluting beads loaded with irinotecan (DEBIRI) in patients with unresectable colorectal cancer liver metastases.

Detailed description

Colorectal cancer is the second most common malignant tumor and the fifth cause of cancer death in my country, and its incidence rate is increasing year by year. The liver is the main target organ for hematogenous metastasis of colorectal cancer and the main cause of death in patients with colorectal cancer. About 15% to 25% of patients with colorectal cancer have liver metastases when diagnosed, and another 15% to 25% of patients will develop liver metastases after radical resection of the primary colorectal cancer site. The vast majority (80%) %\~90%) of liver metastases cannot be curatively resected initially. The median survival of patients with untreated liver metastases is only 6.9 months, and the 5-year survival rate of patients with unresectable liver metastases is less than 5%. The median survival time of patients who have completely resected liver metastases or reached a state of no evidence of disease is 35 months, and the 5-year survival rate can reach 30% to 57%. For patients with unresectable colorectal cancer liver metastases, the first-line treatment option recommended by the guidelines is multi-agent chemotherapy with or without targeted therapy. Currently, there are limited clinical studies on the use of uniform particle size drug-loaded microspheres combined with chemotherapy drugs and targeted drugs to treat unresectable colorectal cancer liver metastases. Based on this, a single-arm, prospective study is planned to be carried out, using conversion resection rate as the main efficacy indicator, to explore the efficacy of embolization therapy with uniform particle size drug-loaded microspheres loaded with irinotecan combined with systemic chemotherapy and bevacizumab versus systemic chemotherapy combined The efficacy and safety of bevacizumab in the treatment of patients with unresectable colorectal cancer liver metastases provide a more reliable basis for clinical treatment in this field.

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
COMBINATION_PRODUCT	DEBIRI Combined With Chemotherapy and Bevacizumab	After dissolving 100 mg of irinotecan in water for injection or 4ml of 5% glucose water.use 2mL of 70μm uniform particle size microspheres for loading and adsorption for 5minutes. Then mixed with non-plasma contrast agent to embolize the tumor feeding artery.

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-01-01
• Completion: 2025-05-01
• First posted: 2023-12-20
• Last updated: 2023-12-20

Locations

1 site across 1 country: China