NCT06329947尚未招募2 期
A Phase II Study of Surufatinib Combined With Camrelizumab and mFOLFOX6 as Second-line Treatment for Advanced PRAD
Rui-hua Xu, MD, PhD1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2024年5月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- objective response rate (ORR)
研究概览
简要总结
To preliminarily evaluate whether there is a survival benefit of surufatinib combined with camrelizumab and mFOLFOX6 as the second-line treatment for advanced pancreatic cancer, and to explore the feasibility of second-line and post-line treatment for advanced pancreatic cancer
详细描述
Second-line clinical study of surufatinib in combination with Caralizumab advanced pancreatic cancer
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
- •Have full understanding of this study and voluntarily sign the informed consent form;
- •Male and Female aged between 18 and 75 years are eligible;
- •Histologically or cytologically confirmed metastatic pancreatic cancer;
- •Patients who have previously failed first-line gemcitabine-based chemotherapy or have disease progression/recurrence during previous neoadjuvant/adjuvant treatment or within 6 months after the end of treatment are considered to have failed first-line systemic chemotherapy; neoadjuvant/adjuvant treatment plan Also gemcitabine-based chemotherapy;
- •Presence of at least one measurable target lesion for further evaluation according to RECIST criteria;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- •Predicted survival ≥12 weeks;
- •Males or female of childbearing potential must: agree to use using a reliable form of contraception (eg, oral contraceptives, intrauterine device, control sex desire, double barrier method of condom and spermicidal) during the treatment period and for at least 6 months after the last dose of study drug.
排除标准
- •Participated in other anti-tumor drug clinical trials within 28 days;
- •Have previously received any anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody or acted on T cell costimulation or checkpoints Treatment with any other antibodies of the pathway (such as OX40, CD137, etc.);
- •Have previously received anti-vascular endothelial growth factor/vascular endothelial growth factor receptor (VEGF/VEGFR) targeted drug treatment;
- •Those who are known to be allergic to any of the drugs in the study;
- •Brain metastasis accompanied by symptoms or symptom control time <2 months;
- •The subject has suffered from other malignant tumors in the past or at the same time within 5 years (except cured basal cell carcinoma of the skin and cervical cancer in situ);
- •Insufficient bone marrow hematopoietic function (without blood transfusion within 14 days):
- •Absolute neutrophil count (ANC) <1.5×109/L;
- •Platelets <100×109/L;
- •Hemoglobin <8g/dL.
- •Liver abnormalities:
- •When there is no liver metastasis, ALT, AST or ALP>2.5×the upper limit of the normal reference range (ULN); when there is liver metastasis, ALT, AST or ALP>5×ULN;
- •Serum total bilirubin >1.5×ULN (Gilber syndrome >3×ULN);
- •Decompensated cirrhosis (Child-Pugh liver function grade B or C);
- •Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA copy number ≥2000IU/mL (those who are HBsAg positive and hepatitis B virus DNA copy number <2000IU/mL need to receive at least 2 weeks of anti-HBV treatment before taking the first dose) ;
- •Hepatitis C virus (HCV) antibody positive and HCVRNA test positive.
- •Kidney abnormalities:
- •Serum creatinine>1.5×ULN;
- •Routine urine test shows urine protein ≥++, and the 24-hour urine protein quantification is confirmed to be >1.0g;
- •Renal failure requiring hemodialysis or peritoneal dialysis;
- •Past history of nephrotic syndrome.；
研究组 & 干预措施
Experimental group
Experimental
Surufatinib in combination with Camrelizumab and mFOLFOX6
干预措施: Surufatinib 250mg/d qd once daily (Drug)
结局指标
主要结局
objective response rate (ORR)
时间窗: Time Frame: up to 24 months
Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
次要结局
- disease control rate (DCR)(Time Frame: up to 24 months)
- Progression-Free Survival (PFS)(Time Frame: up to 24 months)
- overall survival (OS)(Time Frame: up to 24 months)
- quality of life (QoL)(Time Frame: up to 24 months)
- adverse events (AE)(Time Frame: up to 24 months)
研究者
Rui-hua Xu, MD, PhD
Chief physician
Sun Yat-sen University
研究点 (1)
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