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

Phase 2

Recruiting

• Conditions: Neuroendocrine Tumors; Neuroendocrine Carcinoma
• Interventions: Drug: Chidamide; Drug: Etoposide + Cisplatin/Carboplatin

• Registration Number: NCT05076786
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-18
• Study First Submitted QC: 2021-09-29
• Study First Posted: 2021-10-13
• Study Start: 2021-10-27
• Last Update Submitted: 2021-11-02
• Last Update Posted: 2021-11-03
• Primary Completion: 2022-10-15
• Study Completion: 2024-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chidamide + Etoposide + Cisplatin/Carboplatin	Etoposide + Cisplatin/Carboplatin	Experimental arm will be treated by chidamide combined with etoposide and cisplatin/carboplatin regimen for 4-6 cycles.
Chidamide + Etoposide + Cisplatin/Carboplatin	Chidamide	Experimental arm will be treated by chidamide combined with etoposide and cisplatin/carboplatin regimen for 4-6 cycles.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Up to 2 years	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

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate (DCR)	Up to 2 years	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
Progression-free Survival (PFS)	Time from the date of enrollment to the earliest of documented disease progression or death, assessed up to 2 years	Time from the date of enrollment until progression or death, whichever is first met
Overall Survival (OS)	Time from the date of enrollment to the earliest of documented death, assessed up to 3 years	Time from the date of enrollment until death
Treatment-related Adverse Events (Safety)	Up to 2 years	Frequency and grade of adverse events (the grade of adverse events is assessed according to CTCAE v4.03).

Trial Locations

Locations (3)

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, Heilongjiang, China

Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, China