An interventional study of DEBIRI Combined With Chemotherapy and Bevacizumab in Colorectal Neoplasms, sponsored by Fudan University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-12-20.
Sponsored by Fudan University · Not applicable, Interventional, and Treatment
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 39 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
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Exclusion Criteria:
After dissolving 100 mg of irinotecan in water for injection or 4 ml of 5% glucose water, use 2 mL of 70 μm uniform particle size microspheres for loading and adsorption for 5 minutes. Then mixed with non-plasma contrast agent to embolize the tumor feeding artery.
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.
converted resection rate
Discussed and determined by the MDT of the research center.
Time frame: 1, 3, 6 months after surgery
Actual R0 resection rate
Postoperative pathological examination.No cancer cells can be found at the resection margin of the postoperative specimen under a microscope. There are no cancer cells remaining either to the naked eye or under a microscope, and the lesion has been completely removed.
Time frame: 1, 3, 6 months after surgery
Progression Free Survival
Time from initiation of treatment to tumor progression or death from any cause, whichever occurs first
Time frame: 1, 3, 6 months after surgery
Recurrence-free survival
Time from date of curative surgery to recurrence or death
Time frame: 1, 3, 6 months after surgery
Adverse events
Adverse medical events that occur to subjects during clinical trials
Time frame: 1, 3, 6 months after surgery
This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Fudan University