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

NCT ID: NCT05076786

Last Updated: 2021-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-27

Study Completion Date

2024-10-15

Brief Summary

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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

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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

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Neuroendocrine Tumors Neuroendocrine Carcinoma

Keywords

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Histone Deacetylase Inhibitors Chidamide Neuroendocrine Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chidamide + Etoposide + Cisplatin/Carboplatin

Experimental arm will be treated by chidamide combined with etoposide and cisplatin/carboplatin regimen for 4-6 cycles.

Group Type EXPERIMENTAL

Chidamide

Intervention Type DRUG

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

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Epidaza EP/EC regimen

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role collaborator

Harbin Medical University

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chunmei Bai, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Site Status RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunmei Bai, M.D.

Role: CONTACT

Phone: 69158706

Email: [email protected]

Facility Contacts

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Chunmei Bai, M.D.

Role: primary

Feng Ye, M.D.

Role: primary

Lei Liu, M.D.

Role: primary

Other Identifiers

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HS-3125

Identifier Type: -

Identifier Source: org_study_id