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Nimotuzumab plus concurrent chemo-radiotherapy in unresectable locally advanced oesophageal squamous cell carcinoma (ESCC): interim analysis from a Phase 3 clinical trial

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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Fig. 1: Flowchart.
Fig. 2: Short-term efficacy.
Fig. 3: Subgroup analysis.

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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.

Funding

The authors received no specific funding for this work.

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Authors and Affiliations

Authors

Contributions

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.

Corresponding author

Correspondence to Jinming Yu.

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The authors declare no competing interests.

Ethics approval and consent to participate

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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