NCT00972465: Nimotuzumab plus irinotecan for colorectal cancer

NCT00972465 investigated nimotuzumab plus irinotecan as second-line treatment for metastatic colorectal cancer with wild-type KRAS. The Peking University protocol was registered as phase IIa with dose escalation and 48 anticipated participants. The actual published conference report must be distinguished from that planned sample. 1 2

Zhou, Shen and Gao's 2012 ASCO/JCO abstract e14122 explicitly names this identifier and reports 31 patients, enrolled July 2009–November 2011, with median age 55. Nimotuzumab was given weekly at 200, 400, 600 or 800 mg alongside irinotecan 180 mg/m² every two weeks. In the 600-mg group, 4/12 patients had a partial response (33.3%) and 3/12 had stable disease (25%). 3

This is an early, single-arm dose-escalation abstract, not a randomized comparison with irinotecan alone. The small, unequal dose groups cannot establish an optimal dose or survival benefit. The citation supplies actual response observations without treating the investigators' preliminary enthusiasm as definitive efficacy. 3

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT00972465. Original registration; establishes the exact study identity and registered methods.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT00972465. Original registration; establishes the exact study identity and registered methods.

2. ICH GCP — ICH GCP — NCT00972465. Readable reproduction of the sponsor-submitted registration, including the design and dated status fields; not an independent outcome study.Cited supporting source · Link and description preserved from supplied research. Checked in supplied research dated 2026-10-10. Source description comes from supplied research; underlying page was not independently re-read for this update.

3. Zhou J, Shen L, Gao J (2012). A dose escalation study of nimotuzumab plus irinotecan as second-line treatment in metastatic colorectal cancer with wild-type K-ras. Journal of Clinical Oncology 30(15_suppl):e14122; DOI 10.1200/jco.2012.30.15_suppl.e14122. Original ASCO conference abstract, explicitly linked to NCT00972465; preliminary evidence, not a full randomized efficacy report — Zhou J, Shen L, Gao J (2012). A dose escalation study of nimotuzumab plus irinotecan as second-line treatment in metastatic colorectal cancer with wild-type K-ras. Journal of…Cited supporting source · Link and description preserved from supplied research. Checked in supplied research dated 2026-10-10. Source description comes from supplied research; underlying page was not independently re-read for this update.