A Phase II Study of SHR6390 Plus Nab-paclitaxel and Gemcitabine in Unresectable Advanced/Metastatic Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 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
The study is being conducted to evaluate the efficacy, safety and tolerability of SHR6390 in combination with nab-paclitaxel and gemcitabine in first-line treatment of subjects with advanced/metastatic pancreatic cancer.
详细描述
This is an open-label, prospective, single-center, single-arm, Simon's two-stage design phase II study for unresectable advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) subjects treated with SHR6390 plus nab-paclitaxel and gemcitabine.
In this research study, the main objectives include:
- Evaluate objective response rate in patients with pancreatic cancer receiving SHR6390 plus nab-paclitaxel and gemcitabine.
- Assess adverse side effects associated with the combination of SHR6390 with nab-paclitaxel and gemcitabine.
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
- •Male or female of 18 to 75 years old;
- •Subjects are diagnosed with histologically confirmed unresectable advanced or metastatic pancreatic ductal adenocarcinoma with at least one measurable lesion according to the RECIST 1.1 standard (the CT scan length of the tumor lesion > 10 mm);
- •Subjects are naïve to systemic treatment;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- •Life expectancy ≥12 weeks;
- •Adequate organ performance based on laboratory blood tests;
- •The toxicity of the previous treatment has been restored to ≤1 level (if there is surgery, the wound has completely healed);
- •Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation;
- •Normal swallowing function;
- •Willing to consent and signed the informed consent, and able comply with the planned visit, research treatment, laboratory examination and other test procedures.
排除标准
- •Had other active malignant tumors within 5 years before entering the study;
- •Confirmed or suspicious new metastatic lesion in brain;
- •Subjects are allergy to experimental drugs or any excipients;
- •Coagulation disorders (INR>1.5, APTT>ULN);
- •Severe pleural effusion or ascites;
- •Severe and uncontrolled medical diseases, acute infections; recent history of major surgery for myocardial infarction (within 3 months);
- •Subjects combined with other anti-tumor drugs;
- •Chronic diarrhea or intestinal obstruction;
- •Pregnant or lactating women; Fertile subjects who are unwilling or unable to take effective contraceptive measures;
- •Subjects in any trial drug treatment;
- •Severe mental disorder;
- •Other situations that investigators considered should be excluded.
研究组 & 干预措施
AG+SHR6390
Subjects will receive SHR6390 plus nab-paclitaxel and gemcitabine
干预措施: SHR6390 (Drug)
AG+SHR6390
Subjects will receive SHR6390 plus nab-paclitaxel and gemcitabine
干预措施: Nab-paclitaxel (Drug)
AG+SHR6390
Subjects will receive SHR6390 plus nab-paclitaxel and gemcitabine
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to 2 years.
ORR is defined as the proportion of patients with best objective response of confirmed complete response (CR) or partial response (PR) according to RECIST1.1.
Adverse Events (AEs)
时间窗: From the first drugs administration to within 30 days for the last treatment.
AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
次要结局
- Overall Survival (OS)(Up to 2 years.)
- Progression Free Survival (PFS)(Up to 2 years.)
- Disease Control Rate (DCR)(Up to 2 years.)