Experimental Tumor
Conditions
Brief summary
Study of Chidamide as a Single-agent Treatment for Patients With Recurrent and Metastatic Epstein-Barr virus (EBV)-associated Solid Tumors
Detailed description
Chidamide，a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to observe the efficacy and safety of Chidamide as a single-agent treatment in patients with recurrent and metastatic Epstein-Barr virus (EBV)-associated solid tumors.
Interventions
DRUGChidamide
Chidamide 30mg orally BIW. Treatment cycles are repeated every 4 weeks.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate（ORR） | up to 2 years | the total proportion of patients with complete response（CR）and partial response（PR） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate （DCR） | up to 2 years | the total proportion of patients with complete response（CR）, partial response（PR）and Stable Disease（SD） |
| Duration of Response （DOR） | up to 2 years | Time from first documented complete response (CR) or partial response (PR) until time of progression. |
| progression-free survival（PFS） | 2 years | Time from treatment until disease progression or death |
| overall survival（OS） | 2 years | Time from treatment until death from any cause |
Countries
China
Contacts
Primary ContactLi Zhang, MD
Backup ContactWenfeng Fang, MD
Outcome results
None listed