Phase II Study of Irinotecan Liposome II Combined with Cetuximab and Bevacizumab for Treating Irinotecan-Resistant Advanced Colorectal Cancer

What this Trial Is About

Researchers are evaluating a combination treatment using irinotecan liposome II for patients with colorectal cancer that is resistant to irinotecan. This phase II clinical study aims to observe and assess both the safety and effectiveness of this treatment approach in patients whose cancer has advanced despite previous therapies. The trial is conducted by the Chinese PLA General Hospital and focuses on patients with advanced colorectal cancer who have measurable tumors and have undergone at least second-line systemic cancer treatment. The study treatment combines irinotecan liposome II, cetuximab, and bevacizumab, all given by intravenous infusion every two weeks starting on Day 1 of each cycle. Dosages are adjusted for certain genetic mutations. Treatment continues in 2-week cycles until cancer progression, unacceptable side effects, initiation of new anti-cancer therapy, patient withdrawal, or investigator decision. If disease progresses as defined by RECIST criteria, treatment may continue if the patient is still benefiting and tolerating it well. Participants will have regular safety visits before each treatment cycle to monitor adverse events. Researchers will measure progression-free survival up to three years as the primary outcome. Secondary outcomes include overall response rate, disease control rate, overall survival, duration of response, and safety measures. Laboratory tests and assessments of organ function will be conducted throughout. The study started in September 2024 and will follow patients until July 2027.

Clinical Study of Irinotecan Liposome (II)-Based Combination Treatment for Irinotecan-resistant Colorectal Cancer.