A Bayesian Optimal Phase II Design for Randomized Immunotherapy Trials with Delayed Treatment Effects
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具有延迟治疗效应的随机免疫治疗试验贝叶斯最优二期设计
- 研究问题
- 免疫治疗效应延迟出现并导致非比例风险时，如何设计随机二期试验，使治疗分离时点的不确定性得到处理并维持检验表现？
- 方法与思路
- 作者在 BOP2 框架中为治疗效应分离时点设置截断 Gamma 先验，提出 DTE-BOP2 设计，结合先验信息与错误率控制。
- 材料陈述的贡献
- 摘要称模拟中该设计在多种延迟情景下控制一类错误，并相较所列基准获得较高功效和较小样本量，另提供 R 包。
- 阅读关注点
- 应核对延迟效应与生存分布模型、先验参数及错误率校准方式，以及模拟比较中的样本量、效应设定和延迟范围。
- 阅读边界
- 这是 arXiv 预印本，同行评审或期刊接收未经核实；摘要未提供完整设计规则与模拟数值，软件可用性及性能优势也未经独立核验。
原文摘要
Immunotherapy has transformed cancer treatment, yet its delayed therapeutic effects often lead to non-proportional hazards, rendering many conventional phase II designs underpowered and prone to type I error inflation. To address this issue, we propose a novel Bayesian Optimal Phase II design (DTE-BOP2) that explicitly models the uncertainty in the separation timing of treatment effect. The treatment separation timepoint (denoted by S) is endowed with a truncated-Gamma prior, whose parameters can be elicited from experts or inferred from historical data, with default settings available when prior knowledge is scarce. Built upon the BOP2 framework (Zhou et al. 2017, 2020), our design retains operational simplicity while incorporating type I error control and maintaining the power. Extensive simulations demonstrate that DTE-BOP2 uniformly controls type I error at the nominal level across a wide range of treatment effect separation timepoint S. We further observe that the power decreases monotonically as S increases. Importantly, we find that the power is primarily driven by the relative magnitude of treatment benefit before and after the separation time, i.e., the ratio of medians, rather than their absolute values. Compared to the original BOP2, the piecewise weighted log-rank, and the conventional log-rank tests, DTE-BOP2 achieves higher power with smaller sample sizes while preserving type I error robustness across plausible delay scenarios. An open-source R package, DTEBOP2 (CRAN), with detailed vignettes, enables investigators to implement the design and analyse phase-II trials exhibiting delayed treatment effects.