Irinotecan Hydrochloride Lioposome (Hunan Jingfeng)

Phase II - Treatment Regimen Exploration Stage:
1. Evaluate the safety and efficacy of the following three treatment regimens:
Liposomal irinotecan + 5-FU/LV + bevacizumab + Enlonstobart (Group A) Liposomal irinotecan + 5-FU/LV + bevacizumab (Group B) Irinotecan + 5-FU/LV + bevacizumab (Group C)
2. Provide a basis for selecting the treatment regimen for the confirmatory phase.
3. Explore the relationship between tumor tissue, stool, and blood biomarkers and efficacy and adverse reactions in liposomal irinotecan combination regimens versus irinotecan combination regimens.
Phase III - Efficacy Confirmation Stage:
Compare the efficacy and safety of liposomal irinotecan combination regimens versus irinotecan combination regimens in second-line treatment of metastatic colorectal cancer.

In second line with advanced or recurrent biliary tract cancer refractory to first line gemcitabine plus cisplatin,efficacy of mFOLFOX/FOLFIRI vs mFOLFOX will be evaluated at randomized phase 2 trial.