NCT06361888招募中2 期
A Multicenter, Randomized, Open-label, Active-controlled, Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine Versus Nab-paclitaxel Plus Gemcitabine as the First-line Treatment in Metastatic Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Hutchmed
- 入组人数
- 502
- 试验地点
- 53
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
To evaluate the efficacy of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer
详细描述
This is a multicenter, randomized, open-label, active-controlled, phase II/III trial to evaluate the efficacy and safety of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully understand and voluntarily sign an informed consent form, willing and able to follow the study process;
- •Age range is 18-75 years old (inclusive);
- •Pancreatic cancer confirmed by histology or cytology;
- •Stage IV metastasis Pancreatic cancer patients;
- •Have not received previous systematic first line anti-tumor treatment in the stage of metastatic pancreatic cancer;
- •According to RECIST 1.1, there is at least one measurable lesion;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1;
- •Expected survival time ≥ 12 weeks;
排除标准
- •Use of systematic non-specific immunomodulatory therapy within 2weeks prior to the first dose；
- •Presence of other malignancies in the past 5 years;
- •Received major surgical surgery within 4 weeks before the first dose;
- •Received palliative radiotherapy within 1 week before the first dose; received radical radiotherapy within 4 weeks before the first dose;
- •Any known allergy to surufatinib or its components, camrelizumab, nab-paclitaxel, or gemcitabine;
- •Received strong-inducers or strong-inhibitors of cytochrome P450 (CYP) 3A within 2 weeks or 5 half-lives (whichever is longer) before the first dose;
- •Use of immunosuppressive drugs within 4 weeks before first dose;
- •Known history of clinically significant liver disease, including active viral hepatitis infection or other active hepatitis or clinically significant moderate to severe cirrhosis;
- •Patients who currently have hypertension that cannot be controlled by medication;
研究组 & 干预措施
Nab-paclitaxel Plus Gemcitabine
Active Comparator
干预措施: Nab-paclitaxel Plus Gemcitabine (Drug)
Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine
Experimental
干预措施: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine (Drug)
Surufatinib with Nab-paclitaxel, and Gemcitabine
Other
干预措施: Surufatinib with Nab-paclitaxel, and Gemcitabine (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From date of first dose of study drug until withdrawal of consent or death (up to approximately 20 months)
Duration from the date of initial treatment to the date of death due to any cause
次要结局
- Progression-free Survival (PFS) (RECIST1.1)(From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months))
- Objective response rate (ORR)(RECIST1.1)(From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months))
- Duration of response (DoR)(RECIST1.1)(From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months))
- Disease control rate (DCR)(RECIST1.1)(From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months))
- Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)（only for phase III）(From the within 7 days prior to the initiation of treatment to 30 days after the last administration)
- Cancer Quality of Life Questionnaire - PAN26(EORTC QLQ-PAN26)（only for phase III）(From the within 7 days prior to the initiation of treatment to 30 days after the last administration)
- Progression-free Survival (PFS) (RECIST1.1)(From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months))
- Objective response rate (ORR)(RECIST1.1)(From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months))
- Duration of response (DoR)(RECIST1.1)(From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months))
- Disease control rate (DCR)(RECIST1.1)(From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months))
- Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)（only for phase III）(From the within 7 days prior to the initiation of treatment to 30 days after the last administration)
- Cancer Quality of Life Questionnaire - PAN26(EORTC QLQ-PAN26)（only for phase III）(From the within 7 days prior to the initiation of treatment to 30 days after the last administration)
- Safety and tolerability(From the date of first dose of study drug to 90 days after the last administration)
研究者
研究点 (53)
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