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

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05076786
Collaborator
The First Affiliated Hospital of Xiamen University (Other), Harbin Medical University (Other)
28
Enrollment
3
Locations
1
Arm
35.6
Anticipated Duration (Months)
9.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 27, 2021
Anticipated Primary Completion Date :
Oct 15, 2022
Anticipated Study Completion Date :
Oct 15, 2024

Arms and Interventions

ArmIntervention/Treatment
Experimental: Chidamide + Etoposide + Cisplatin/Carboplatin

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

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.
Other Names:
  • Epidaza
  • 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.
    Other Names:
  • EP/EC regimen
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    3. 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

    4. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical SciencesBeijingBeijingChina100032
    2The First Affiliated Hospital of Xiamen UniversityXiamenFujianChina361003
    3Harbin Medical University Cancer HospitalHarbinHeilongjiangChina150040

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Chunmei Bai, M.D., Peking Union Medical College Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT05076786
    Other Study ID Numbers:
    • HS-3125
    First Posted:
    Oct 13, 2021
    Last Update Posted:
    Nov 3, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Peking Union Medical College Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 3, 2021