Correction: First-line treatment of camrelizumab combined with chemotherapy in advanced gastroenteropancreatic neuroendocrine carcinoma: study protocol for a prospective, multicenter, phase II study
Xiaofen Li, Qing Ma, Chen Chang, Hao Li, Dan Cao
Abstract
Genes, proteins, chemicals, diseases, species, mutations and cell lines named across the full text — each resolved to its canonical identifier and authoritative record.
- —Sichuan Provincial Science and Technology Support Program10.13039/100012542
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Taxonomy
TopicsNeuroendocrine Tumor Research Advances · Lung Cancer Research Studies · Thyroid Cancer Diagnosis and Treatment
The sample size calculation was updated based on a revised statistical design.
A correction has been made to the section Methods and analysis, Sample size and statistical analyses, Paragraph 1:
“This study aimed to achieve a 6-month PFS rate of 50%. Sample size was determined using Simon’s optimal two-stage design for the primary endpoint of 6-month PFS rate (revised in version 4.0 of the protocol with approval from the ethics committee), with a type I error of 0.05 and 80% power. In the first stage, 6 evaluable patients were enrolled; if at least 2 patients achieved a PFS of ≥ 6 months, the study would proceed to the second stage with an additional 14 patients, for a total of 20 evaluable patients. The regimen would be considered promising if at least 8 patients in total achieved a 6-month PFS or longer. Assuming an approximately 10% non-evaluable/ dropout rate, we planned to enroll about 22 patients to obtain 20 evaluable patients.”
The tumor type was updated. A correction has been made to the section Methods and analysis, Study design and Treatment, Paragraph 2:
“The main inclusion criteria are pathologically confirmed locally advanced or metastatic extra-pulmonary neuroendocrine carcinoma (EP-NEC), with the primary sites located in non-pulmonary organs such as the gastrointestinal tract, pancreas, or biliary tract;”
Also revised in Table 1 inclusion 1:
“1. Histologically and/or cytologically confirmed, unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinoma (EP-NEC), with primary sites located in non-pulmonary organs such as the gastrointestinal tract, pancreas, or biliary tract;The pathological diagnosis of gastrointestinal neuroendocrine carcinoma will be established according to the 2019 WHO Classification of Tumours of the Digestive System;”
The original version of this article has been updated.