A Prospective, One-arm, Phase II Clinical Study of Tislelizumab Combined With Anlotinib and Investigator-selected Chemotherapy for Second-line Treatment of Advanced or Metastatic Pancreatic Cancer: a
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- MedianProgression free survival(mPFS)
研究概览
简要总结
This is a prospective, one-arm, phase II clinical study of Tislelizumab Combined With Anlotinib and Chemotherapy for Second-line Treatment of Advanced or Metastatic Pancreatic Cancer
详细描述
This is a single-arm, open-label, clinical trial of tislelizumab in combination with anlotinib and investigator-selected chemotherapy for second-line treatment of patients with advanced or metastatic pancreatic cancer. Patients with histopathologically or cytologically confirmed unresectable, recurrent or metastatic pancreatic cancer are planned to be recruited. Systemic medical antineoplastic therapy previously treated with first-line chemotherapy, meeting the inclusion and exclusion criteria of this study, and giving tislelizumab and anlotinib in combination with investigator 's choice of second-line chemotherapy regimen
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
- •Advanced or metastatic pancreatic adenocarcinoma diagnosed by pathology;
- •Previously received a standard first-line chemotherapy regimen of pancreatic cancer
- •Age ≥ 18 and≤ 75 years old;
- •Expected survival ≥ 3 months;
- •ECOG score 0-1;
- •Child-Pugh score < 8;
- •There is at least one measurable tumor lesion: the long diameter is ≥10 mm, and the short diameter of lymph nodes is ≥15 mm;
- •The results of liver and kidney function and blood routine examination within 1 week before enrollment meet the following conditions:
- •Neutrophils (ANC) ≥ 1.5×109/L, platelets (PLT) ≥ 80×109/L, hemoglobin (HGB) ≥ 80g/L; Serum creatinine (Cr) ≤ 1.5 × upper limit of normal value; total bilirubin (TBIL) ≤ 2.5 × upper limit of normal value, Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤2.5× upper limit of normal value;
- •The patient voluntarily participated in this study and signed the informed consent form.
排除标准
- •Received other immunotherapy previously(including immune checkpoint inhibitor PD-1/PDL1 and other immune checkpoint inhibitors) and/or anti-angiogenic drugs (including anti-VEGFR monoclonal antibody and anti-angiogenic small molecule kinase inhibitors) ; Known to be severely allergic to the drugs used in the study of tislelizumab and anlotinib;
- •Patients with obstructive jaundice who cannot reach TBIL ≤ 2.5 times the upper limit of normal value after surgical intervention;
- •Patients with biliary obstruction that may occur or worsen within 4 to 6 weeks;
- •Obvious blood coagulation disorder, active bleeding and bleeding tendency;
- •There is a history of other malignant tumors within 5 years (adequately treated skin basal cell carcinoma, cervical in situ);
- •Interstitial pneumonia or pulmonary fibrosis;
- •Uncontrollable pleural effusion or ascites;
- •Severe uncontrolled medical diseases, acute infections, recent history of myocardial infarction (within 3 months);
- •During pregnancy or breastfeeding, and those who refuse to take appropriate contraceptive measures during the test;
- •Patients judged by the investigator to be inappropriate to participate in this study.
研究组 & 干预措施
Tislelizumab Combined With Anlotinib and Chemotherapy
Tislelizumab iv drip, every 3 weeks; Anlotinib, oral，once a day; chemotherapy will be choiced by investigator according guildline.
干预措施: Tislelizumab (Drug)
结局指标
主要结局
MedianProgression free survival(mPFS)
时间窗: from enrollment to disease progression or death from any cause, up to 24 months
assessment by RECIST v1.1,at end of per 2 treatment cycles(each cycle is 21 days)
次要结局
- disease control rate(DCR)(up to 24 months)
- objective response rate(ORR)(from enrollment to disease progression or death from any cause,up to 24 months)
- Median Overall Survival(from enrollment to death from any cause,up to 24 months)