NCT04777162Unknown2 期
Efficacy and Safety of Tislelizumab Plus Anlotinib in PD-1/PD-L1 Resistant Metastatic Gastric or Colorectal Cancer: a Single Arm Phase II Clinical Trial
Peking University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- objective response rate
研究概览
简要总结
Immunotherapy acquired resistance was observed in clinical practice. The investigators intended to add anlotinib to PD-1 inhibitors, hoping reverse the resistance.
详细描述
Anti-angiogenesis seems have positive effects on tumor immune microenvironment. the combination of PD-1/PD-L1 inhibitors and TKIs exhibited favorable efficacy on gastrointestinal malignancies. Here the investigators want to examine the efficacy and survival benefit from the combination therapy to PD-1 acquired resistance patients, which turns out to be critical issues in recent years.
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
- •ECOG scored 0 or 1, ≥18 years old, expected OS≥3 months;
- •Histology confirmed unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma or colorectal cancer;
- •≥1 evaluable lesion based on RECIST 1.1;
- •Patients received PD-1/PD-L1 in the last treatment line, and should meet following conditions:
- •i) there was no severe immune-related adverse events, ii) the duration between tumor progression and screening should be 3-12 weeks, iii) the best evaluation results should be PR or CR when receiving PD-1/PD-L1 treatment but progression was confirmed in the latest evaluation, iv) patients were diagnosed with special pathology subtypes, that are sensitive to immunotherapy, such as dMMR, MSI-H tumors, or gastric cancer with PD-L1 CPS≥10, PFS≥6 months in the last treatment line;
- •laboratory test should meet following standard: i) HB≥90g/l, neutrophils≥1.5*10^9/L, plt≥100*10^9, ii) ALT and AST<2.5xULN (5ULN for liver metastatic patients), TBIL≤2×ULN, Cr≤1.5×ULN, and Ccr>50μmol/L iii) APTT, INR and PT≤1.5×ULN iv) LVEF≥50%
- •for female participants, Hcg should be negative and both male and female participants should have contraception measures
- •participants should be informed consent, and voluntary.
排除标准
- •received anlotinib or other TKIs previously;
- •allergic to other monoclonal antibody before the treatment;
- •diagnosed with other malignancy in last five years (cured skin basal carcinoma, prostate cancer or cervical caner in situ were excluded)
- •concurrent with other active autoimmune disease;
- •any condition that require immune suppressor, such as cortisol (>10mg/d prednisone equally), CTX;
- •conditions affect oral absorption (eg: dysphagia, intestinal obstruction; chronic diarrhea);
- •uncontrolled pleural effusion, hydropericardium and seroperitoneum;
- •brain metastasis;
- •received other anti-tumor treatment in past 3 weeks, eg: surgery, radiotherapy, target therapy, immunotherapy, and traditional Chinese therapy (target therapy less than 5 half-life period, 5-Fu less than 14 days were excluded);
- •concurrent with uncontrolled other diseases, i) hypertension (>150/90mmHg) ii) unstable angina pectoris, ≥ level 2 heart failure, arrhythmia within last 6 months; iii) clinical meaningful liver disease, eg: active HBV/HCV hepatitis; iv) HIV positive; v) uncontrolled diabetes; vi) urine protein ≥++ or 24h urine protein >1g;
- •injected vaccine in past 4 weeks, or administrated with antibiotics;
- •investigator assumed improper conditions, such as mental disease, family or society factors.
研究组 & 干预措施
tislelizumab+anlotinib
Experimental
patients will be administrate with dual drugs, tislelizumab plus anlotinib.
干预措施: Anlotinib (Drug)
tislelizumab+anlotinib
Experimental
patients will be administrate with dual drugs, tislelizumab plus anlotinib.
干预措施: Tislelizumab (Drug)
结局指标
主要结局
objective response rate
时间窗: 2 years
the rate of patients reached PR or CR based on RECIST 1.1
次要结局
- progression-free survival(Up to 2 years)
- overall survival(Up to 2 years)
研究者
Shen Lin
Professor
Peking University
研究点 (1)
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