NCT05478473招募中不适用
Clinical Study of Chidamide Combined With Toripalimab in the Treatment of Advanced Melanoma
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2022年10月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
The study was a single-arm study designed to evaluate the efficacy and safety of Chidamide combined with Toripalimab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged ≥ 18 years, male or female
- •histologically and/or cytologically confirmed melanoma, clinically diagnosed as inoperable stage III-IV
- •previous treatment for advanced tumors (including chemotherapy, targeted, anti-vascular drugs, etc.) failure or no standard treatment, and no PD- (L) 1/CTLA-4 drug treatment; if neoadjuvant/adjuvant therapy has received PD- (L) 1/CTLA-4 drug treatment, the total duration of drug treatment should be ≥6 months
- •if there is brain metastasis, local treatment must have been received before participating in this study and clinical stability ≥ 3 months
- •ECOG score 0-1
- •at least one measurable lesion (according to RECISTv1.1 evaluation criteria)
- •absolute neutrophil count ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin ≥ 90 g/L
- •other organ function needs to meet: ① cardiac function needs to meet: left ventricular ejection fraction ≥ 50%, no organic arrhythmia; ② liver function needs to meet: ALT and AST ≤ 2.5 times the upper limit of normal (such as with liver metastasis, ALT and AST ≤ 5 times the upper limit of normal), total bilirubin ≤ 1.5 times the upper limit of normal;③ renal function needs to meet: creatinine ≤ 1.5 times the upper limit of normal; ④ coagulation function: international normalized ratio (International Normalized Ratio,INR) ≤ 1.5 times upper limit of normal; prothrombin time (PT), activated partial thromboplastin time (APTT) ≤ 1.5 times upper limit of normal (unless the subject was receiving anticoagulant therapy and PT and APTT were within the expected range of anticoagulant therapy at screening); ⑤ Thyroid function: thyrotropin (TSH) or free thyroxine (FT4) or free triiodothyronine (FT3) were within ± 10% of normal values.
- •Expected survival time ≥ 3 months
- •Voluntarily participate in this clinical trial and sign a written informed consent.
- •Previous anti-tumor therapy (chemotherapy, radiotherapy, targeting, traditional Chinese medicine, other immunotherapy) requires eluting for 28 days.
- •The adverse effects of previous antitumor therapy were resolved to grade 0-1 before the screening period (as determined by NCI CTCAE 5.0; Except for toxicity, such as hair loss, which the investigator determined did not pose a safety risk to the subject)
排除标准
- •no measurable lesions, such as pleural or pericardial exudates, ascites, etc.
- •choroidal melanoma
- •previous treatment with HDAC inhibitors (including cedaramide, romidepsin, vorinostat, bellistat, panobinostat, etc.)
- •history of interstitial lung disease or pneumonia requiring oral or intravenous steroids
- •previous vaccination or planned vaccination with live vaccines (seasonal influenza vaccine without live vaccines is allowed), major surgery within 30 days before the first study treatment
- •active infection [active bacterial, viral, fungal, mycobacterial, parasitic infections or other infections (excluding fungal infections of the nail bed) within 4 weeks before the screening period, or any major infection event requiring intravenous antibiotic therapy, or targeted antiviral therapy, or hospitalization; Active hepatitis is defined as HBsAg positive with HBV DNA≥500 IU/ml or HCV antibody positive with HCV copy number > the upper limit of normal], or persistent fever within 14 days before screening
- •history of immunodeficiency, including positive HIV testing, or other acquired, congenital immunodeficiency diseases, or history of organ transplantation
- •uncontrolled cardiovascular disease; history of clinically significant QT prolongation, or screening period > 470 ms for females and > 450 ms for males
- •positive baseline pregnancy test in female subjects who are pregnant or lactating or fertile females; or subjects of childbearing age who are unwilling to take effective contraceptive measures for at least 180 days during study participation and after the last dose of study drug
- •According to the investigator 's judgment, there are concomitant diseases that seriously jeopardize the subject' s safety or affect the subject 's completion of the study (e.g., severe hypertension ≥ 180/110 mmHg, uncontrolled diabetes, thyroid disease, Hypertriglyceridemia ≥ grade 2, etc.)
- •History of definite neurological or psychiatric disorders, including epilepsy or dementia
- •Any condition that, in the opinion of the investigator, would make participation in this study inappropriate.
研究组 & 干预措施
Chidamide combined with Toripalimab
Experimental
干预措施: Chidamide combined with Toripalimab (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Up to approximately 24 months
Objective response rate (ORR)as measure of efficacy by RECIST 1.1
次要结局
- Progression Free survival （PFS）(Up to approximately 24 months)
- Overall Survival（OS）(Up to approximately 24 months)
- Duration of Response(DoR)(Up to approximately 24 months)
- Disease control rate（DCR）(Up to approximately 24 months)
- Incidence Rate of each Toxicity (safety and tolerability)(Up to approximately 24 months)
研究者
Jun Guo
Director
Peking University Cancer Hospital & Institute
研究点 (1)
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