Efficacy and Safety of PD-L1 Inhibitor in Patients With Advanced Solid Tumors Beyond Lung Cancer: a PhaseⅠB Clinical Study
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 主要终点
- DCR
研究概览
简要总结
Anti-PD-L1 immune checkpoint inhibitor, is approved for the treatment of patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy, or as first-line treatment of patients with ES-SCLC in combination with etoposide and either carboplatin or cisplatin in China. The clinical data regarding the PD-L1 inhibitor in other solid tumors are limited.Investigators would observe and analyze the effectiveness and safety of PD-L1 inhibitor for patients with advanced - solid tumors beyond lung cancer after muti-line therapy to explore the synergistic effect of PD-L1 inhibitor rechallenge after PD-1immunotherapy.
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
- •Signed Informed Consent Form
- •Ability to comply with protocol
- •Aged ≥ 18 years
- •Histologically documented advanced solid tumor beyond lung cancer
- •Disease progression during or following at least one line treatment containing PD-1 immunotherapy.
- •Measurable disease, as defined by RECIST v1.1
- •ECOG performance status of 0 or 1
- •Life expectancy ≥ 12 weeks
- •Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment:
- •ANC ≥ 1.5 × 109/L (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility) WBC counts > 2.5 × 109/L and < 15 × 109/L Lymphocyte count ≥ 0.5 × 109/L Serum albumin ≥ 2.5 g/dL Platelet count ≥ 100 × 109/L (without transfusion within 2 weeks of laboratory test used to determine eligibility) Hemoglobin ≥ 9.0 g/dL Patients may be transfused or receive erythropoietic treatment to meet this criterion.
- •Liver function tests meeting one of the following criteria:
- •AST or ALT ≤ 2.5 × upper limit of normal (ULN), with alkaline phosphatase
- •≤ 2.5 × ULN or AST and ALT ≤ 1.5 × ULN in conjunction with alkaline phosphatase > 2.5 × ULN Serum bilirubin ≤ 1.5 × ULN Patients with known Gilbert's disease who have serum bilirubin level ≤ 3 × ULN may be enrolled. INR and aPTT ≤ 1.5 × ULN This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose for at least 1 week prior to randomization. Creatinine clearance ≥ 30 mL/min Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration, or Modification of Diet in Renal Disease formulas may be used for creatinine clearance calculation. Note that 24-hour urine collection is not required but is allowed.
排除标准
- •Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
- •Leptomeningeal disease
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- •Uncontrolled hypertension
- •Autoimmune disease
- •Had undergone a serious anaphylactic reaction in previous immunotherapy
研究组 & 干预措施
PD-L1 rechallenge
干预措施: PD-L1 inhibitor (Drug)
结局指标
主要结局
DCR
时间窗: At the end of Cycle 3 (each cycle is 21 days)".
Disease Control Rate
PFS
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
progression-free survival
次要结局
- AE(hrough study completion, an average of 1 year)
- OS(From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months)
研究者
zhangxiaochun
director
The Affiliated Hospital of Qingdao University