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

NCT05076786 | Unknown Phase 2

• 1 other identifier: HS-3125
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

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.

Conditions

Neuroendocrine Tumors; Neuroendocrine Carcinoma

Keywords

Histone Deacetylase Inhibitors; Chidamide; Neuroendocrine Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Disease Control Rate (DCR)

  Up to 2 years

• Progression-free Survival (PFS)

  Time from the date of enrollment to the earliest of documented disease progression or death, assessed up to 2 years

• Overall Survival (OS)

  Time from the date of enrollment to the earliest of documented death, assessed up to 3 years

• Treatment-related Adverse Events (Safety)

  Up to 2 years

Study Arms (1)

Chidamide + Etoposide + Cisplatin/Carboplatin

EXPERIMENTAL

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

Drug: Chidamide; Drug: Etoposide + Cisplatin/Carboplatin

Interventions

Chidamide 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.

Also known as: Epidaza

Chidamide + Etoposide + Cisplatin/Carboplatin

Etoposide + Cisplatin/Carboplatin 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.

Also known as: EP/EC regimen

Chidamide + Etoposide + Cisplatin/Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years;
• Histologically confirmed locally advanced and metastatic extrapulmonary neuroendocrine carcinoma;
• No systematic treatments for neuroendocrine carcinoma are received before enrollment;
• ECOG ≤ 2;
• Have at least one measurable lesion according to RECIST version 1.1, and the lesion has not received any local treatments;
• Absolute neutrophil count ≥ 1.5×109 / L, platelet count ≥ 100×109 / L, hemoglobin ≥ 90 g/L;
• Have ability to sign a written informed consent.

You may not qualify if:

• Have surgery or trauma within 4 weeks before enrollment, or are expected to receive surgical treatment;
• Previous use of HDAC inhibitors;
• Allergy to related drug components;
• Have a medical history of immune deficiency diseases, or organ transplantation;
• Have uncontrolled or significant cardiovascular disease;
• 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);
• Pregnancy ;
• Have serious diseases that may endanger the safety of patients, or affect patients to complete the research;
• Any serious mental or cognitive disorder;
• Patients are currently enrolled in another drug clinical trial within 4 weeks prior to enrollment;
• Any other condition which is inappropriate for the study in the opinion of the investigators.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• The First Affiliated Hospital of Xiamen University: collaborator
• Harbin Medical University: collaborator

Study Sites (3)

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

Beijing, Beijing Municipality, 100032, China

RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150040, China

RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors; Carcinoma, Neuroendocrine

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Etoposide; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes

Study Officials

• Chunmei Bai, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunmei Bai, M.D.

CONTACT

69158706; baichunmei1964@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2021
• First Posted: October 13, 2021
• Study Start: October 27, 2021
• Primary Completion: October 15, 2022
• Study Completion: October 15, 2024
• Last Updated: November 3, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)