A Multi-center, Open-label, Randomized Controlled Clinical Study of Nab-paclitaxel Plus SHR-1210(PD-1 Inhibitor)Versus Nab-paclitaxel As Second-line Treatment in Advanced or Recurrent Gastric and Esophagogastric Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- objective response rate(ORR)
研究概览
简要总结
This is a Multi-center, Open-label, Randomized Controlled,phase 2 clinical trail of Albumin-bound Paclitaxel Plus SHR-1210 （PD-1 inhibitor）Versus Albumin-bound Paclitaxel as Second-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma
详细描述
This is a Multi-center, Open-label, Randomized Controlled,phase 2 clinical trail of an immune checkpoint inhibitor in patients with advanced or recurrent gastric and esophagogastric junction adenocarcinoma, including two arms to compare the efficacy and safety of Albumin-bound Paclitaxel Plus SHR-1210 （PD-1 inhibitor）regimen and Albumin-bound Paclitaxel single-agent regimen in second-line treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18-70 years.
- •Second line treatment for cytological or histological diagnosis of recurrent or metastatic gastric and esophagogastric adenocarcinoma. Disease progression after adjuvant therapy within 6 months is eligible.
- •ECOG performance status of 0-
- •Estimated life expectancy of at least 3 months.
- •Bone marrow function: white blood cell count≥3.0×109 /L, absolute neutrophil count(ANC) ≥1.5×109 /L, platelet count(PLT) ≥90×109 /L, hemoglobin(HB) ≥90 g/L.
- •Left ventricular ejection fraction (LVEF) ≥ 50%.
- •Liver and kidney function: Creatinine(Cr)≤1.5 x upper limit of normal range(ULN); alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper limit of normal range (ULN), or ≤5 x upper limit of normal range (ULN)when with hepatic metastases，total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN), or≤2.5 x upper limit of normal range (ULN) when with Gilbert's syndrome.
- •Any acute, clinically significant treatment-related toxicity caused by previous treatment must have been reduced to less than or equal to grade 1, except hair loss.
- •Able and willing to comply with the study plans in this protocol and sign the informed consent.
排除标准
- •uncontrollable infections or have received systematic antibiotic treatment within 72 hours before enrollment.
- •Any abnormal bone marrow hyperplasia or other abnormal hematopoietic function.
- •Have a second malignancy within 5 years prior to registration except for cured carcinoma in situ of cervix uteri, non-melanoma skin cancer.
- •Patients with symptomatic brain metastases.
- •Allergic to the chemotherapy drugs or the materials in this study.
- •Suffering from mental or nervous system disorders and unable to cooperate.
- •Pregnant or nursing female patients. Men and women of reproductive age are unwilling to take reliable contraceptive measures during the study.
- •Active autoimmune disease, history of autoimmune disease, use of corticosteroids or immunosuppressants, or use of hormone replacement therapy, such as thyroxine, insulin, etc.
- •Live vaccine was administered within 30 days before enrolment (injectable seasonal influenza vaccine is allowed as it is inactivated).
- •Patients with other diseases not suitable for enrolment, such as active tuberculosis, hepatitis B (after treatment, hepatitis B virus titer HBV-DNA <500IU/ml, and liver function is normal, but cannot be combined with hepatitis C), hepatitis C, uncontrolled electrolyte disorders ,pericardial effusion, pleural effusion and abdominal effusion, etc.
- •Have participated in other clinical trials within 30 days prior to this study.
- •History of organ transplantation.
- •Patients that researcher consider cannot sign informed consent or complete the study.
研究组 & 干预措施
Nab-P/PD-1
Patients in this arm receive albumin-bound paclitaxel and SHR-1210 (PD-1 inhibitor) thepary.
干预措施: Albumin-bound Paclitaxel Plus SHR-1210 (PD-1 inhibitor) (Drug)
Nab-P
Patients in this arm receive albumin-bound paclitaxel single-agent chemotherapy.
干预措施: Albumin-bound Paclitaxel (Drug)
结局指标
主要结局
objective response rate(ORR)
时间窗: up to 12 months
The rate of participants that achieve either a complete response (CR) or a partial response (PR).Higher rate of ORR indicates better treatment effect.
次要结局
- Progression-free Survival (PFS)(up to 9 months)
- Overall survival (OS)(up to 12 months)
- Safety as measured by number and grade of adverse events(up to 12 months)
- patient-reported outcomes (PROs)(up to 12 months)
研究者
Xianglin Yuan
Professor, Head of the cancer center
Huazhong University of Science and Technology