{'fraction_non_alphanumeric': 0.014986376021798364, 'fraction_numerical': 0.0, 'mean_word_length': 4.92741935483871, 'pattern_counts': {'":': 0, '<': 0, '<?xml version=': 0, '>': 0, 'https://': 0, 'lorem ipsum': 0, 'www.': 0, 'xml': 0}, 'pii_count': 0, 'substrings_counts': 0, 'word_list_counts': {'cursed_substrings.json': 0, 'profanity_word_list.json': 0, 'sexual_word_list.json': 0, 'zh_pornsignals.json': 0}}
Optimal Two-Stage Design for the Phase II Cancer Clinical Trials With Responses and Early Progression as Co-primary Endpoints

In phase II cancer clinical trials of newly developed cytostatic or molecularly targeted agents, it is proposed to use both response and early progression rate as co-primary endpoints of the trials. An agent is considered promising if either its response rate is high or its early progression rate is low. In this article, we present some strategies for the search of optimal two-stage designs, which minimizes the expected total sample size under null hypothesis and has its Type I and II errors bounded above by prespecified values. Examples are given for several scenarios appearing in clinical practice.