Chidamide for Patients With Recurrent and Metastatic Epstein-Barr Virus (EBV)-Associated Solid Tumors

Study Overview
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Brief Summary
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Study of Chidamide as a Single-agent Treatment for Patients With Recurrent and Metastatic Epstein-Barr virus (EBV)-associated Solid Tumors

Detailed Description
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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.

Official Title
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Study of Chidamide as a Single-agent Treatment for Patients With Recurrent and Metastatic Epstein-Barr Virus (EBV)-Associated Solid Tumors

Conditions
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Experimental Tumor

Intervention / Treatment
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* Drug: Chidamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; At least one measurable lesion according to criteria RECIST v1.1; Age 18-70 years, male or female; ECOG performance status 0-2; Life expectancy no less than 3 months; Adequate hepatic, renal and bone marrow function; History of brain metastasis is eligible, but maintenance of hormone is not required; Contraception during and 4 weeks after the study for patients at child bearing age; Patients have signed the Informed Consent Form. Exclusion Criteria: Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures; 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; pericardial effusion ≥10mm sum of echo-free spaces by echocardiography; Patients have undergone organ transplantation; Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment; Patients with active hemorrhage; Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction; Patients with active HBV or HCV infection; continuous fever within 14 days prior to enrollment; Had major organ surgery within 6 weeks prior to enrollment; 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); Patients with mental disorders or those do not have the ability to consent; Patients with drug abuse, long term alcoholism that may impact the results of the trial; Patients who received treatment of HDAC inhibitors; Non-appropriate patients for the trial according to the judgment of the investigators.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chidamide<br> | Drug: Chidamide<br>* Chidamide 30mg orally BIW. Treatment cycles are repeated every 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate（ORR） | the total proportion of patients with complete response（CR）and partial response（PR） | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate （DCR） | the total proportion of patients with complete response（CR）, partial response（PR）and Stable Disease（SD） | up to 2 years | 
| Duration of Response （DOR） | Time from first documented complete response (CR) or partial response (PR) until time of progression. | up to 2 years | 
| progression-free survival（PFS） | Time from treatment until disease progression or death | 2 years | 
| overall survival（OS） | Time from treatment until death from any cause | 2 years |