# A Clinical Study of Liposomal Irinotecan for Second-Line Therapy in Metastatic Colorectal Cancer

Source: https://onco.cc/trials/nct07585279/  
OnCo record `nct07585279` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2/3 trial of irinotecan (and liposomal irinotecan), fluorouracil (5-FU), leucovorin (folinic acid), bevacizumab (glioblastoma use) and other drugs in colorectal cancer, run by Hebei Medical University Fourth Hospital, not yet recruiting.

## Summary

A Clinical Study of Liposomal Irinotecan for Second-Line Therapy in Metastatic Colorectal Cancer is a phase 2/3, randomised interventional study registered as NCT07585279 by Hebei Medical University Fourth Hospital, with a registry enrolment figure of 408 participants, started 2026-05-20 and due to reach its primary completion in 2031-02-28. Interventions recorded: Liposomal irinotecan + 5-FU/LV + bevacizumab + Enlonstobart; Irinotecan liposome + 5-FU/LV + Bevacizumab; Irinotecan + 5-FU/LV + Bevacizumab. Conditions listed: Metastatic Colorectal Cancer (CRC); Liposomal Irinotecan; Second-Line. Primary outcome: ORR. Colorectal eligibility wording from the registry: "Histologically or cytologically confirmed metastatic colon or rectal adenocarcinoma;". Sites: China. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: planned
- Last checked: 2026-09-24
- Tags: ctgov-ingest; colorectal-deep-dive
- Registry id: NCT07585279
- Phase: 2/3
- Setting: Liposomal Irinotecan-based Regimen Versus Irinotecan-based Regimen in Second-Line Treatment for Metastatic Colorectal Cancer (IRIS-02): A Randomized, Controlled Phase II/III Study
- Sponsor: Hebei Medical University Fourth Hospital
- Enrolled: 408

## Sources

- ClinicalTrials.gov NCT07585279: https://clinicaltrials.gov/study/NCT07585279

## Connected records

- cancers: [Colon cancer (adenocarcinoma of the colon)](https://onco.cc/cancers/colon-cancer/), [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/)
- drugs: [Bevacizumab (glioblastoma use)](https://onco.cc/drugs/bevacizumab-glioma/), [Fluorouracil (5-FU)](https://onco.cc/drugs/fluorouracil/), [FOLFIRI (5-FU, leucovorin, irinotecan)](https://onco.cc/drugs/folfiri/), [Irinotecan (and liposomal irinotecan)](https://onco.cc/drugs/irinotecan/), [Leucovorin (folinic acid)](https://onco.cc/drugs/leucovorin/)
- terms: [Colorectal cancer trials open today (registry snapshot)](https://onco.cc/terms/colorectal-trials-open-today/)

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