Abstract
Background
This prospectively randomised, double-blinded, placebo-controlled, multicenter Phase 3 clinical trial was conducted to assess the efficacy and safety profile of nimotuzumab (nimo) plus concurrent chemo-radiotherapy (CCRT) in patients with unresectable locally advanced ESCC.
Methods
Patients were randomly assigned (1:1) to receive CCRT plus nimotuzumab or placebo. The primary endpoint was overall survival (OS). In addition, interim analysis for short-term response rate was pre-defined.
Results
A total of 201 patients were randomised into two groups. Eighty patients in the nimo group and eighty-two in the placebo group were evaluable. Three to six months after treatment, 26 (32.5%) patients achieved complete response (CR) in the nimo group, and 10 (12.2%) in the placebo group (P = 0.002). The ORR of the nimo group was significantly higher than the placebo group (93.8% vs. 72.0%, P < 0.001). The two groups’ grade 3–5 adverse drug reactions were 11.1% vs. 10.9% (P > 0.05).
Conclusions
Nimotuzumab, in combination with chemo-radiotherapy, increased the CRR and ORR with a good safety profile. The OS is needed to be followed and finally analysed.
Clinical trial registration
NCT02409186.
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Data availability
To gain data access, researchers need to email to the corresponding author to obtaining individual participant data that underline the results reported in this article after identification.
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Acknowledgements
This study has been presented as a poster discussion at the 2022 American Society of Clinical Oncology Annual Meeting (Abstract No: 4016). Many thanks to all the patients and their families. Thank all the caregivers, investigators, and site personnel.
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The authors confirm contribution to the paper as follows: study conception and design: JY, XM, AZ and JW; data collection: XM, AZ, JW, X Wu, GL, JZ, HM, XZ, AS, CD, SY, BWg, ZQ, CH, XS, MY, RF, NH and X Wang; analysis and interpretation of results: XM, AZ and JW; draft manuscript preparation: XM and JY. All authors reviewed the results and approved the final version of the manuscript.
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This study was conducted in accordance with the Declaration of Helsinki. All patients gave their written informed consent. The institutional ethics committees at each site approved the protocol.
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Meng, X., Zheng, A., Wang, J. et al. Nimotuzumab plus concurrent chemo-radiotherapy in unresectable locally advanced oesophageal squamous cell carcinoma (ESCC): interim analysis from a Phase 3 clinical trial. Br J Cancer 129, 1787–1792 (2023). https://doi.org/10.1038/s41416-023-02388-7
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DOI: https://doi.org/10.1038/s41416-023-02388-7