NCT05076786

Chidamide Plus Etoposide and Cisplatin/Carboplatin as First-line Treatment for Extrapulmonary Neuroendocrine Carcinoma

Chidamide Plus Etoposide and Cisplatin/Carboplatin as First-line Treatment for Advanced Extrapulmonary Neuroendocrine Carcinoma: a Prospective, Multicenter, Single-arm, Phase 2 Clinical Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a single-arm, multi-center, two-stage, phase II clinical trial conducted in China. This study adopts Simon's two-stage design, and the inclusion criteria and exclusion criteria of the two stages were consistent. Twelve patients with extrapulmonary neuroendocrine carcinoma will be enrolled in the first stage. If more than four complete or partial responses were seen at planned interim analysis, the additional 16 patients will be recruited in the second stage and a total of 28 patients will be treated.

Conditions

• Neuroendocrine Tumors
• Neuroendocrine Carcinoma

Interventions

Type	Name	Description
DRUG	Chidamide	20mg, administered orally. Week 1/2: twice a week (d0, d4, d7, d11); Week 3: stop. Repeat every 3 weeks for 4-6 cycles.
DRUG	Etoposide + Cisplatin/Carboplatin	Etoposide (100mg/m2; intravenous infusion; d1-3) + Cisplatin (75mg/m2; intravenous infusion; d1). Repeat every 3 weeks for 4-6 cycles. OR Etoposide (100mg/m2; intravenous infusion; d1-3) + Cisplatin (25mg/m2; intravenous infusion; d1-3). Repeat every 3 weeks for 4-6 cycles. OR Etoposide (100mg/m2; intravenous infusion; d1-3) + Carboplatin (AUC=5; intravenous infusion; d1). Repeat every 3 weeks for 4-6 cycles.

Timeline

• Start date: 2021-10-27
• Primary completion: 2022-10-15
• Completion: 2024-10-15
• First posted: 2021-10-13
• Last updated: 2021-11-03

Locations

3 sites across 1 country: China