A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- ORR per RECIST v1.1 and imRECIST as assessed by investigators
研究概览
简要总结
This is a Phase Ib/II, open-label, single arm trial to evaluate the efficacy and safety of AK104 in combination with axitinib as a first-line treatment for advanced/metastatic special pathological subtypes of renal cell carcinoma (ssRCC). Subjects will receive AK104 plus axitinib until disease progression, development of unacceptable toxic effects, death, a decision by the physician or patient to withdraw from the trial. The primary endpoint is ORR and PFS per RECIST v1.1 and imRECIST as assessed by investigators.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age≥18, ≤75;
- •histology characteristics accord with special pathological subtypes of RCC: papillary renal cell carcinoma, chromophobic cell carcinoma, TFE3 rearrangement renal cell carcinoma, FH-deficient renal cell carcinoma, collecting duct carcinoma, medullary carcinoma, sarcomatoid carcinoma (>10%), unclassified renal cell carcinoma ;
- •metastatic renal cell carcinoma (TNM IV stage according to the 2009 TNM Staging system).
- •Patients who have not previously received systemic therapy, ECOG (Eastern Cooperative Oncology Group)≤2;
- •expected survival >3 months;
- •all patients signed informed consent.
- •blood routine indexes: neutrophils ≥1.5*109, platelets ≥100*109, hemoglobin ≥90g/L;
- •liver function: bilirubin ≤ normal upper limit 1.5 times, ALT/AST≤ normal upper limit 2.5 times;Serum creatinine ≤ 1.5 times of normal upper limit
- •the following diseases did not appear within 12 months: myocardial infarction, severe or unstable angina pectoris, asymptomatic heart failure, cardiovascular and cerebrovascular accident or transient ischemic attack, etc.
排除标准
- •other malignancies previously or at the same time that are different from the primary site or histology of the tumor assessed in this study, except cervical carcinoma in situ, basal-cell carcinoma that has been fully treated, superficial bladder tumor (Ta, Tis, T1) or other malignancies that occurred before the enrollment and have been cured for more than 3 years;
- •renal decompensation requires hemodialysis or peritoneal dialysis;
- •arrhythmia need anti-arrhythmic treatment, symptomatic coronary artery disease or myocardial ischemia (myocardial infarction), nearly six months, or congestive heart failure than NYHA Ⅱ level; Hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg) that has been treated with 2 or more antihypertensive treatments and still cannot be controlled;
- •severe active clinical infection;
- •patients with coagulation disorder or bleeding constitution;
- •major surgery or severe trauma was performed within 4 weeks before enrollment;
- •a history of allogeneic organ transplantation or bone marrow transplantation;
- •drug abuse and medical, psychological or social conditions that may interfere with patients' participation in research or affect the evaluation of results;
- •known or suspected allergy to the study drug;
- •those who received treatment other than this study within 4 weeks prior to and during the study period.
研究组 & 干预措施
Combination treatment group
Subjects in this group will receive AK104 (RP2D, administered intravenously) plus Axitinib 5 mg bid, administered orally.
干预措施: AK104 (Drug)
Combination treatment group
Subjects in this group will receive AK104 (RP2D, administered intravenously) plus Axitinib 5 mg bid, administered orally.
干预措施: Axitinib (Drug)
结局指标
主要结局
ORR per RECIST v1.1 and imRECIST as assessed by investigators
时间窗: 3 years
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1 and imRECIST
次要结局
- PFS per RECIST v1.1 and imRECIST as assessed by investigators(3 years)
- Pain score(3 years)
- Life quality Questionnaire composite(3 years)
- DCR per RECIST v1.1 and imRECIST as assessed by investigators(3 years)
- OS(3 years)
研究者
Hao Zeng
professor
West China Hospital