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

Neuroendocrine Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05076786
• Other study ID #: HS-3125
• Status: Recruiting
• Phase: Phase 2
• Start date: October 27, 2021
• Est. completion date: October 15, 2024

Study information

• Verified date: September 2021
• Source: Peking Union Medical College Hospital
• Contact: Chunmei Bai, M.D.
• Phone: 69158706
• Email: baichunmei1964[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: October 15, 2024
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Neuroendocrine
• Neuroendocrine Carcinoma
• Neuroendocrine Tumors

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian

Sponsors (3)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Harbin Medical University, The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	Percentage of participants with complete response and partial response, assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1	Up to 2 years
Secondary	Disease Control Rate (DCR)	Percentage of participants with complete response, partial response, and stable disease assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1	Up to 2 years
Secondary	Progression-free Survival (PFS)	Time from the date of enrollment until progression or death, whichever is first met	Time from the date of enrollment to the earliest of documented disease progression or death, assessed up to 2 years
Secondary	Overall Survival (OS)	Time from the date of enrollment until death	Time from the date of enrollment to the earliest of documented death, assessed up to 3 years
Secondary	Treatment-related Adverse Events (Safety)	Frequency and grade of adverse events (the grade of adverse events is assessed according to CTCAE v4.03).	Up to 2 years