Liposomal Irinotecan in Combination with Sintilimab in Second-Line Treatment of Progressive Gastric Cancer, a Single-Arm, Single-Center, Open-Label, Phase II Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 27
- 主要终点
- overall response rate,ORR
研究概览
简要总结
Evaluating the efficacy and safety of irinotecan liposome injection in combination with Sintilimab in the second-line treatment of progressive gastric cancer
详细描述
This is a single-center, open, single-arm clinical study to evaluate the efficacy and safety of irinotecan liposome injection in combination with Sintilimab in the second-line treatment of progressed gastric cancer, and to provide more clinical treatment options for gastric cancer patients.
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 years old, gender is not limited;
- •Pathologically confirmed adenocarcinoma (originating from the stomach and gastroesophageal junction);
- •Clinical documentation of failure of prior standard therapy (treatment with at least 1 cycle of standard chemotherapy regimen, disease progression or intolerance during treatment, or disease progression after completion of treatment).
- •An Eastern Cooperative Oncology Group (ECOG) physical status score of 0 to 2;
- •Have equivalent organ function, i.e., meet the following criteria:
- •a.Routine blood tests:
- •Neutrophils ≥ 1.5 × 109 /L;
- •Leukocytes ≥ 3.5 × 109 /L;
- •Platelets ≥ 75 × 109 /L;
- •hemoglobin ≥70 g/L; b. Biochemical examination:
- •Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (subjects with biliary obstruction, after biliary drainage ≤ 5 × ULN);
- •≤ 5 x ULN for alanine aminotransferase (AST) and alanine aminotransferase (ALT) in subjects with liver metastases
- •Albumin level ≥ 28 g/L;
- •creatinine clearance ≥ 60 ml/min; c.Cardiac function tests:
- •normal ECG or abnormal ECG (not clinically significant in the judgment of the investigator)
- •Left ventricular ejection fraction (LVEF) ≥ low limit of normal;
- •Previous surgery, radiotherapy, chemotherapy or other anti-tumor treatment need to end the treatment for 4 weeks or more, and the general physical condition or related adverse reactions have recovered (toxic reaction ≤ grade 1) or reached a stable state;
- •Participate voluntarily and sign the informed consent form;
- •Good compliance, agree to cooperate with the survival follow-up.
排除标准
- •Patients previously treated with irinotecan;
- •Subjects with ascites requiring clinical intervention (including subjects with moderate to large amounts of ascites, if the subject's ascites needs to be stabilized for more than 4 weeks after drainage);
- •Clinically significant gastrointestinal-like illness (including bleeding, infectious inflammation, perforation, obstruction, or diarrhea greater than grade 1);
- •second primary malignant tumor within 5 years (except for cured carcinoma in situ, basal or squamous cell skin cancer; subjects with other previous neoplasms that have not recurred within 5 years may be enrolled);
- •Suffering from uncontrolled cardiac or cerebral diseases or clinical symptoms, including but not limited to: ① NYHA class III or higher heart failure; ② unstable angina; ③ myocardial infarction or stroke within 6 months; ④ supraventricular or ventricular arrhythmia requiring treatment or intervention; ⑤ uncontrollable hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >90 mmHg after optimal treatment) ;
- •Subjects with known active hepatitis B (HBsAg positive and HBV DNA ≥ 103 copies or ≥ 1000 U/ml);
- •Active infection or unexplained fever >38.5°C during the Screening Period or on the day of dosing (in the investigator's judgment, fever due to neoplasia may be enrolled), which, in the investigator's judgment, would interfere with the subject's participation in this trial or interfere with the evaluation of efficacy;
- •Known hypersensitivity to any component of irinotecan hydrochloride liposomes or other liposomes;
- •Pregnant or lactating women;
- •Positive screening blood (urine) pregnancy test in women of childbearing potential (male and female subjects should use reliable contraception to prevent pregnancy during the trial and for 3 months after the last dose);
- •other medical or social problems that, in the judgment of the investigator, may affect the subject's ability to sign an informed consent, to participate in the trial study, or to influence the interpretation of the trial results.
研究组 & 干预措施
treatment
The patients with Progressive Stage Gastric Cancer will be enrolled and given Sintilimab: 200 mg over 1 hour IV, given every 3 weeks. Irinotecan Liposome Injection II: 56.6 mg/m2 (free base) every 3 weeks, depending on the dose.
Sequence of administration: Sindilizumab and Irinotecan Liposome Injection II will be given sequentially.
Pre-treatment medication: Dexamethasone and antiemetic (or prophylactic irinotecan if preferred according to hospital practice).
干预措施: Irinotecan liposome injection Ⅱ (Drug)
treatment
The patients with Progressive Stage Gastric Cancer will be enrolled and given Sintilimab: 200 mg over 1 hour IV, given every 3 weeks. Irinotecan Liposome Injection II: 56.6 mg/m2 (free base) every 3 weeks, depending on the dose.
Sequence of administration: Sindilizumab and Irinotecan Liposome Injection II will be given sequentially.
Pre-treatment medication: Dexamethasone and antiemetic (or prophylactic irinotecan if preferred according to hospital practice).
干预措施: Sintilimab (Drug)
结局指标
主要结局
overall response rate,ORR
时间窗: up to two years
the best response rate
次要结局
- progression free survival,PFS(up to two years)
- Disease control rate,DCR(up to two years)
- adverse events, AE(up to two years)
研究者
Hao Li
Principal Investigator
Ruijin Hospital