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

• Status: Recruiting
• Trial end date: 2024-10-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborators: Harbin Medical University; The First Affiliated Hospital of Xiamen University
• Treatments: Carboplatin; Etoposide

Criteria

Inclusion Criteria:

1. Age ≥ 18 years;

2. Histologically confirmed locally advanced and metastatic extrapulmonary neuroendocrine carcinoma;

3. No systematic treatments for neuroendocrine carcinoma are received before enrollment;

4. ECOG ≤ 2;

5. Have at least one measurable lesion according to RECIST version 1.1, and the lesion has not received any local treatments;

6. Absolute neutrophil count ≥ 1.5×109 / L, platelet count ≥ 100×109 / L, hemoglobin ≥ 90 g/L;

7. Have ability to sign a written informed consent.

Exclusion Criteria:

1. Have surgery or trauma within 4 weeks before enrollment, or are expected to receive surgical treatment;

2. Previous use of HDAC inhibitors;

3. Allergy to related drug components;

4. Have a medical history of immune deficiency diseases, or organ transplantation;

5. Have uncontrolled or significant cardiovascular disease;

6. 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);

7. Pregnancy ;

8. Have serious diseases that may endanger the safety of patients, or affect patients to complete the research;

9. Any serious mental or cognitive disorder;

10. Patients are currently enrolled in another drug clinical trial within 4 weeks prior to enrollment;

11. Any other condition which is inappropriate for the study in the opinion of the investigators.