Chidamide Plus Etoposide and Cisplatin/Carboplatin as First-line Treatment for Extrapulmonary Neu… (NCT05076786) | Clinical Trial Compass
UnknownPhase 2
Chidamide Plus Etoposide and Cisplatin/Carboplatin as First-line Treatment for Extrapulmonary Neuroendocrine Carcinoma
China28 participantsStarted 2021-10-27
Plain-language summary
The purpose of this study is to explore the efficacy and safety of chidamide combined with etoposide and cisplatin/carboplatin in the first-line treatment of advanced extrapulmonary neuroendocrine carcinoma.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years;
✓. Histologically confirmed locally advanced and metastatic extrapulmonary neuroendocrine carcinoma;
✓. No systematic treatments for neuroendocrine carcinoma are received before enrollment;
✓. ECOG ≤ 2;
✓. Have at least one measurable lesion according to RECIST version 1.1, and the lesion has not received any local treatments;
✓. Have ability to sign a written informed consent.
Exclusion criteria
✕. Have surgery or trauma within 4 weeks before enrollment, or are expected to receive surgical treatment;
✕. Previous use of HDAC inhibitors;
✕. Allergy to related drug components;
✕. Have a medical history of immune deficiency diseases, or organ transplantation;
✕. Have uncontrolled or significant cardiovascular disease;
✕. Abnormal liver function (total bilirubin \> 1.5×upper limit of normal); Transaminases (ALT/AST) \>2.5×upper limit of normal (\>5x upper limit of normal for patients with liver metastases), abnormal renal function (serum creatinine \> 1.5×upper limit of normal);