Neuroendocrine Tumors, Neuroendocrine Carcinoma
Conditions
Keywords
Histone Deacetylase Inhibitors, Chidamide, Neuroendocrine Carcinoma
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.
Interventions
DRUGChidamide
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 (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.
Sponsors
The First Affiliated Hospital of Xiamen University
Harbin Medical University
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
China
Contacts
Primary ContactChunmei Bai, M.D.
Outcome results
None listed