Efficacy and Safety of Anlotinib Plus Toripalimab as First-line Regimen in Frail Patients (ECOG 2) With Advanced Gastric Cancer (APICAL-GC): an Open-label, Single Arm, Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- objective response rate
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of the combination of Anlotinib wiht Toripalimab in advanced gastric cancer with ECOG 2 as first-line regimen.
详细描述
Anlotinib is a new, orally administered tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptors (PDGFR), and c-kit. Toripalimab is a humanized immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (programmed death-1; PD-1), with potential immune checkpoint inhibitory and antineoplastic activities. In the present study, we design a single-arm, single center Phase II trial to evaluate the efficacy and safety of the combination of Anlotinib wiht Toripalimab in advanced gastric cancer with ECOG 2 as first-line treatment.
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
- •Histologically confirmed, UICC stage IV gastric cancer;
- •no prior systematic anti-cancer treatment and relapse or metastases was occurred more than 12 months after adjuvant chemotherapy;
- •at least one measurable lesion;
- •received radiotherapy 3 weeks before recruitment, but the lesion undergoing radiotherapy could not be used to calculate clinical benefit using RECISET criteria;
- •ECOG performance status 2;
- •the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN), ALT and AST <2.5 × ULN and if liver metastases, BIL < 3 × ULN, ALT and AST <5 × ULN; Serum Cr ≤ 1.5 × ULN;
- •Patient's written declaration of consent obtained;
- •Estimated life expectancy > 3 months;
排除标准
- •harboring HER2 positive including IHC 3+ or IHC 2+ with Fish positive;
- •dMMR/MSI-H;
- •Myocardial infarction, unstable angina pectoris, Grade III or IV heart failure (NYHA classification);
- •have received anlotinib or other immune checkpoint inhibitor ;
- •with known or clinically suspected brain metastases, autoimmune disease, organ transplantation ;
- •severe wounds or surgery 4 weeks before recruitment;
- •received glucocorticoid (more than 10mg prednisone ) and immunosuppressive agents;
- •History of a second malignancy during the past 5 years before inclusion in the study or during participation in the study, with the exception of a dermal basal cell or squamous cell carcinoma or cervical carcinoma in situ, if these were treated curatively.
- •pregnancy or breast feeding;
- •absent or restricted legal capacity;
- •a significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study
研究组 & 干预措施
Anlotinib Plus Toripalimab
the combination of Anlotinib Plus Toripalimab as first-line treatment
干预措施: Anlotinib Plus Toripalimab (Drug)
结局指标
主要结局
objective response rate
时间窗: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks
Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission
次要结局
- Progress Free Survival(Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 8 weeks)
- Overall Survival(From date of treatment beginning until the date of death from any cause, through study completion, an average of 8 weeks)
- Deepness of response(Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks)
- Disease control rate(Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks)
- adverse events(Through study completion, an average of 4 weeks)
研究者
Yuan-Sheng Zang
Director
Shanghai Changzheng Hospital