A Prospective, Single-center Clinical Study to Explore the Efficacy and Safety of SHR-1020 Combined With Albumin-bound Paclitaxel in the Second-line Treatment of Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- ORR (Objective Response Rate)
研究概览
简要总结
This study is being conducted to explore the efficacy and safety of SHR-1020 combined with albumin-bound paclitaxel in the second-line treatment of advanced pancreatic cancer.
详细描述
This trial is a prospective, single-center, single-arm clinical research. Advanced pancreatic cancer is an aggressive disease with extremely low 5-year survival rate. For advanced pancreatic cancer patients who failed with first-line treatment, subsequent treatment options are limited. SHR-1020 combined with albumin-bound paclitaxel could through multiple mechanisms such as block tumor mitosis, inhibit tumor angiogenesis, inhibit interstitial fibrosis to achieve anti-tumor effect.
The safety and efficacy of this study will be assessed through ORR, DCR,PFS, OS , and adverse effects as graded by CTCAE 5.0.
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
- •Patients who were diagnosed as metastatic or locally advanced unresectable pancreatic ductal adenocarcinoma by histopathology or cytology, at least one measurable lesion conforming to RECIST 1.1 criteria.
- •Disease progresses or intolerance for first-line standard treatment, including patients who relapsed or metastasized within 6 months of neoadjuvant or adjuvant therapy
- •ECOG score 0-2
- •Adequate organ and bone marrow function
- •The expected survival time is ≥ 12 weeks
- •Had normal swallowing function, without dysfunction of gastrointestinal absorption
- •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
- •The patient has previously received anti-angiogenic drugs or albumin-bound paclitaxel;
- •The first study drug treatment was less than 2 weeks or 5 half-lives (in terms of longer) from the last chemotherapy or 5 half-lives from the last targeted therapy
- •Known to be allergic to the active ingredients or excipients in this study.
- •Had other active malignant tumors within 5 years before entering the study.
- •Subject with cerebral metastasis
- •Have a clear history of serious and uncontrolled other disease or mental disorders;
- •Other chemotherapy, targeted therapy, hormonotherapy, immunotherapy, radiotherapy or traditional Chinese medicine should be used for anti-tumor therapy
- •Other situations that the researcher considers inappropriate to participate in the research.
研究组 & 干预措施
SHR-1020 combined with albumin-bound paclitaxel
SHR-1020 combined with albumin-bound paclitaxel
干预措施: SHR-1020+albumin-bound paclitaxel (Drug)
结局指标
主要结局
ORR (Objective Response Rate)
时间窗: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months]
Containing the incidence of complete response (CR) and partial response (PR). Evaluated according to RECIST 1.1 criteria，subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
次要结局
- Adverse events (per CTCAE v5.0 criteria)(Up to 12months)
- DCR (Disease Control Rate)(From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months])
- PFS (Progression-Free-Survival)(From date of treatment start until the date of progression or the date of death due to any caus, assessed up to 12 months)
- 6mPFS(Up to 6 months)
- OS (overall survival)(From date of treatment start until the date of death from any cause or censored at the last day that the patient is documented to be alive, whichever came first, assessed up to 12 months)