Author

Xiao-Chen Zhu

2 papers indexed here

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Open access Oct 2026

From Phase Ib/II to Seamless Phase II/III: A Simulation-Based Discussion of Design Strategies for Dose Optimization and Confirmatory Phase.

The emergence of targeted therapies and immunotherapies has challenged the traditional "more is better" paradigm underlying maximum tolerated dose (MTD)-based trials, as dose escalation beyond receptor saturation often yields limited additional efficacy while substantially increasing toxicity. In response, the U.S. Foo...

An-Nan Deng, Xiao-Chen Zhu, Hai-Yang Sheng et al. · Clinical pharmacology and th... · 0 citations

Open access Sep 2026

BEACON: An Adaptive Bayesian Early-Phase Oncology Trial Design Integrating Dose Optimization and Proof-of-Concept Across Survival and Binary Endpoints.

Conventional dose selection in oncology, which focuses on the maximum tolerated dose (MTD), has certain limitations for targeted agents and immunotherapies, where the efficacy-toxicity relationship may not be monotonic. Regulatory initiatives such as FDA's Project Optimus highlight the need for improved dose optimizati...

Yi-Ke Tang, Feng Tian, Xiao-Chen Zhu et al. · Pharmaceutical statistics · 0 citations