What question did this study set out to answer?

This study aims to evaluate the efficacy and safety of liposomal irinotecan combined with fluorouracil and bevacizumab in patients with advanced colorectal cancer.

June 26, 2026Open Access

Liposomal irinotecan (HR070803) plus fluorouracil and bevacizumab as second-line treatment in advanced colorectal cancer: Cohort A results from a phase 2 trial.

Key Points

This study aims to evaluate the efficacy and safety of liposomal irinotecan combined with fluorouracil and bevacizumab in patients with advanced colorectal cancer.
Ongoing multicenter, two-cohort phase 2 trial (NCT06540326).
Patients received liposomal irinotecan, fluorouracil/leucovorin, and bevacizumab for 6-9 cycles, followed by maintenance therapy.
Cohort A results reported for 53 enrolled patients with relapsed/metastatic colorectal cancer.
Unconfirmed objective response rate (ORR) of 26.1% (12/46; 95% CI, 14.3-41.1).
Confirmed ORR of 21.7% (10/46; 95% CI, 10.9-36.4).
Median progression-free survival (PFS) was 7.4 months (95% CI, 4.9-not reached).

Abstract

100 Background: Irinotecan-based regimens are standard second-line therapy for advanced colorectal cancer (CRC). Liposomal irinotecan (Lipo-IRI, HR070803) may offer improved safety and efficacy. This study investigated Lipo-IRI combined with fluorouracil and targeted therapy in this setting. Methods: This is an ongoing multicenter, two-cohort phase 2 trial (NCT06540326). Cohort A results are reported. Patients with relapsed/metastatic CRC after first-line therapy received Lipo-IRI (60 mg/m², q2w), 5-FU/leucovorin (modified de Gramont regimen, q2w), and bevacizumab (5 mg/kg, q2w) for 6-9 cycles, followed by maintenance therapy until progression or intolerance. The primary endpoint was objective response rate (ORR). Results: Between Nov 2024 and Oct 2025, 53 patients were enrolled in Cohort A. In the efficacy-evaluable set (n=46), the unconfirmed ORR was 26.1% (12/46; 95% CI, 14.3-41.1) and the confirmed ORR was 21.7% (10/46; 95% CI, 10.9-36.4). With a median follow-up of 5.5 months, the median progression-free survival (PFS) was 7.4 months (95% CI, 4.9-not reached). Grade ≥3 treatment-related adverse events occurred in 18.9% of patients, most commonly decreased neutrophil count (7.5%). Diarrhea (any grade) occurred in 9.4% of patients (grade ≥3: 1.9%). Conclusions: Lipo-IRI combined with fluorouracil and bevacizumab shows promising efficacy and a manageable safety profile as a second-line treatment for advanced CRC, suggesting it may be a good therapeutic option. Clinical trial information: NCT06540326 .

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