Clinical trial · Interventional
Chidamide for Patients With Recurrent and Metastatic Epstein-Barr Virus (EBV)-Associated Solid Tumors
Study of Chidamide as a Single-agent Treatment for Patients With Recurrent and Metastatic Epstein-Barr Virus (EBV)-Associated Solid Tumors
NCT03494634CI-TRIAL-00032480unknownPhase 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)
Study of Chidamide as a Single-agent Treatment for Patients With Recurrent and Metastatic Epstein-Barr virus (EBV)-associated Solid Tumors
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Experimental Tumor | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chidamide
- interventionNames
- Drug: Chidamide
Primary outcomes (1)
- measure
- objective response rate(ORR)
- timeFrame
- up to 2 years
- description
- the total proportion of patients with complete response(CR)and partial response(PR)
Secondary outcomes (4)
- measure
- Disease Control Rate (DCR)
- timeFrame
- up to 2 years
- description
- the total proportion of patients with complete response(CR), partial response(PR)and Stable Disease(SD)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosed as recurrent and metastatic Epstein-Barr virus (EBV)-associated solid tumors, including nasopharyngeal carcinoma and other solid tumors (Lymphoma excluded). Patients must have failed at least one systemic treatment and been refractory to platinum-containing regimens; 2. At least one measurable lesion according to criteria RECIST v1.1; 3. Age 18-70 years, male or female; 4. ECOG performance status 0-2; 5. Life expectancy no less than 3 months; 6. Adequate hepatic, renal and bone marrow function; 7. History of brain metastasis is eligible, but maintenance of hormone is not required; 8. Contraception during and 4 weeks after the study for patients at child bearing age; 9. Patients have signed the Informed Consent Form. Exclusion Criteria: 1. Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures; 2. QTc elongation with clinical significance ( male˃ 450ms, female˃ 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment; 3. pericardial effusion ≥10mm sum of echo-free spaces by echocardiography; 4. Patients have undergone organ transplantation; 5. Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment; 6. Patients with active hemorrhage; 7. Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction; 8. Patients with active HBV or HCV infection; 9. continuous fever within 14 days prior to enrollment; 10. Had major organ surgery within 6 weeks prior to enrollment; 11. Impaired liver function ( Total bilirubin ˃ 1.5 times of normal maximum, ALT/AST˃ 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST ˃ 5 times of normal maximum), impaired renal function (serum creatinin˃ 1.5 times of normal maximum); 12. Patients with mental disorders or those do not have the ability to consent; 13. Patients with drug abuse, long term alcoholism that may impact the results of the trial; 14. Patients who received treatment of HDAC inhibitors; 15. Non-appropriate patients for the trial according to the judgment of the investigators.
References
Publications (0)
Data not yet available
No reference posted for this study.