Clinical trial · Interventional
Chidamide Plus Etoposide and Cisplatin/Carboplatin as First-line Treatment for Extrapulmonary Neuroendocrine Carcinoma
Chidamide Plus Etoposide and Cisplatin/Carboplatin as First-line Treatment for Advanced Extrapulmonary Neuroendocrine Carcinoma: a Prospective, Multicenter, Single-arm, Phase 2 Clinical Study
NCT05076786CI-TRIAL-00054852unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Carcinoma | Neuroendocrine Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide | Drug | — | UNRESOLVED |
| Etoposide + Cisplatin/Carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chidamide + Etoposide + Cisplatin/Carboplatin
- description
- Experimental arm will be treated by chidamide combined with etoposide and cisplatin/carboplatin regimen for 4-6 cycles.
- interventionNames
- Drug: Chidamide
- Drug: Etoposide + Cisplatin/Carboplatin
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Up to 2 years
- description
- 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 outcomes (4)
- measure
- Disease Control Rate (DCR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.