NCT06643793

Evaluation of Irinotecan Liposome (II) Combined With 5-FU, LV, and Bevacizumab for mCRC

Evaluation of Irinotecan Liposome (II) Combined With 5-fluorouracil, Leucovorin, and Bevacizumab for Second-line/Third-line Treatment of Metastatic Colorectal Cancer (mCRC): a Prospective and Exploratory Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Affiliated Hospital of Nantong University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To observe and evaluate the efficacy and safety of irinotecan liposome (II) combined with 5-fluorouracil(5-FU), calcium leucovorin(LV), and bevacizumab in the treatment of metastatic colorectal cancer.

Detailed description

Subjects enter the screening period after being fully informed and signing an informed consent form. The screening period for the study is 28 days. After completing the screening inspection and evaluation, the selected subjects receive irinotecan liposome (II) combined with 5-FU/LV and bevacizumab treatment, a total of 4 anti-tumor treatment cycles were observed. After the 4 cycles of treatment, the next step of treatment was jointly decided after the evaluation of the researcher and the consideration of the patient's personal treatment wishes.

Conditions

• Colorectal Neoplasms Malignant

Interventions

Type	Name	Description
DRUG	Irinotecan liposome (ll) + 5-FU/LV + bevacizumab	1. Bevacizumab: 5 mg/kg, d1, q2w; 2. Irinotecan Hydrochloride Liposomal Injection (II): 60 mg/m2, d1, q2w; 3. leucovorin: 400 mg/m2, d1, q2w; 4. 5-fluorouracil: 2800 mg/m2, d1, q2w.

Timeline

• Start date: 2024-11-04
• Primary completion: 2026-10-31
• Completion: 2026-12-31
• First posted: 2024-10-16
• Last updated: 2025-01-28

Locations

1 site across 1 country: China