# Nimotuzumab Combined With Trifluridine/Tipiracil in the Treatment of Refractory Metastatic Colorectal Cancer

Source: https://onco.cc/trials/nct06343116/  
OnCo record `nct06343116` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of trifluridine/tipiracil in colorectal cancer, run by Biotech Pharmaceutical Co., Ltd., not yet recruiting.

## Summary

Nimotuzumab Combined With Trifluridine/Tipiracil in the Treatment of Refractory Metastatic Colorectal Cancer is a phase 3, randomised interventional study registered as NCT06343116 by Biotech Pharmaceutical Co., Ltd., with a registry enrolment figure of 420 participants, started 2024-04 and due to reach its primary completion in 2027-04. Interventions recorded: Nimotuzumab injection; Placebo; Trifluridine/tipiracil. Conditions listed: Refractory Metastatic Colorectal Cancer. Primary outcome: overall survival (OS); dose-limiting toxicity (DLT). Colorectal eligibility wording from the registry: "Histologically or cytologically confirmed diagnosis of colorectal cancer (CRC);". No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: planned
- Last checked: 2026-09-24
- Also known as: NOTABLE-308
- Tags: ctgov-ingest; colorectal-deep-dive
- Registry id: NCT06343116
- Phase: 3
- Setting: Randomized Double-blind, Placebo-controlled, Multicenter Clinical Study of Nimotuzumab Combined With Trifluridine/Tipiracil in Third-line and Beyond for the Treatment of Metastatic Colorectal Cancer
- Sponsor: Biotech Pharmaceutical Co., Ltd.
- Enrolled: 420

## Sources

- ClinicalTrials.gov NCT06343116: https://clinicaltrials.gov/study/NCT06343116

## 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/)
- drugs: [Trifluridine/tipiracil](https://onco.cc/drugs/trifluridine-tipiracil/)
- terms: [Colorectal cancer trials open today (registry snapshot)](https://onco.cc/terms/colorectal-trials-open-today/)

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