NCT07040228招募中1 期
A Phase Ib/II Clinical Study of Regorafenib Combined With Toripalimab and Albumin-bound Paclitaxel for the Third-line Treatment of Advanced Pancreatic Cancer
Junjie Hang1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2025年5月26日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- (PFS)
研究概览
简要总结
The purpose of this clinical trial is to explore the efficacy and safety of Regorafenib combined with Toripalimab and Paclitaxel-albumin in patients as the third line treatment for patients with unresectable or metastatic pancreatic cancer.The main question it aims to answer is:
Phase Ib: Evaluate the maximum tolerated dose (MTD) of regorafenib and/or phase II clinical recommendations Dose (RP2D).
Phase II: Evaluation of the efficacy and safety of Regorafenib Combined with Terriptylimab and Albumin Paclitaxel for Late Third Line Treatment for pancreatic cancer patients.
Participants will:
Phase Ib: Selected patients will receive treatment with Regorafenib at main dose levels of 40, 80, and 120mg/d (po d1-14 Q3W), Toripalimab(240mg, ivgtt, d1, Q3W), and Paclitaxel-albumi(125mg/m2, ivgtt, d1, 8, Q3W) until disease progression or intolerable toxicity occurs.
Phase II: Regorafenib: Based on the results of the completed Phase I study, determine the dosage for Phase II (po d1-14 Q3W). Toripalimab (240mg, ivgtt, d1, Q3W) and Paclitaxel-albumi (125mg/m2, ivgtt, d1, 8, Q3W) until disease progression or intolerable toxicity occurs.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient fully understands this study, voluntarily participates and signs an informed consent form (ICF);
- •Age ≥ 18 years old and ≤ 80 years old;
- •Patients with unresectable/metastatic pancreatic cancer confirmed by histopathology;
- •Imaging confirmation of tumor progression after previous first-line and second-line standard treatment;
- •According to RECIST 1.1 criteria, patients must have at least one measurable target lesion;
- •Eastern Cancer Collaboration Group (ECOG) Physical Fitness Status Score: 0-2 points;
- •Expected survival time ≥ 2 months;
- •Absolute neutrophil count (ANC) ≥ 1.5 × 10 ^ 9/L, platelets ≥ 100 × 10 ^ 9/L, and hemoglobin ≥ 90 g/L (No blood transfusion or blood products within 14 days prior to laboratory examination.
- •Not treated with granulocyte colony-stimulating factor or other hematopoietic stimulating factors);
- •Liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal value; AST and ALT ≤ 2.5 times the upper limit of normal values (≤ 5 times the upper limit of normal values for patients with liver metastases); Total bilirubin ≤ 1.5 times the upper limit of normal value (≤ 3 times the upper limit of normal value for patients with liver metastasis);
- •Women of childbearing age must undergo a pregnancy test (serum) within 7 days before enrollment, and the result must be negative, And willing to use appropriate contraception methods during the trial period and 6 months after the last administration of the trial drug.
排除标准
- •Have hypersensitivity reactions to any research drug or its components;
- •Concurrent serious uncontrolled infections or other serious uncontrolled accompanying diseases, moderate or severe kidney injury; (such as progressive infection, uncontrollable hypertension, diabetes, etc.);
- •Heart function and disease meet one of the following conditions:
- •Long QTc syndrome or QTc interval>480 ms;
- •Complete left bundle branch block, grade II or III atrioventricular block;
- •Severe and uncontrolled arrhythmias requiring medication treatment;
- •New York College of Cardiology classification ≥ III;
- •Heart ejection fraction (LVEF) below 50%;
- •History of myocardial infarction, unstable angina, and severe unstable ventricular arrhythmia within 6 months prior to recruitment or any other arrhythmia requiring treatment, history of clinically severe pericardial disease, or there may be electrocardiographic evidence of acute ischemic or active conduction system abnormalities.
- •Active infection of hepatitis B and C (hepatitis B virus surface antigen is positive and hepatitis B virus DNA exceeds 1x103 copies/mL; Hepatitis C virus RNA exceeding 1x103 copies/mL).Asymptomatic chronic carriers of hepatitis B or hepatitis C excluded;
- •Human immunodeficiency virus (HIV) infection (HIV antibody positive);
- •Imaging confirms intestinal obstruction;
- •Previously or currently suffering from other malignant tumors simultaneously (Except for non melanoma basal cell carcinoma and breast/cervical carcinoma in situ that have been effectively controlled and other malignant tumors that have been effectively controlled without treatment in the past five years);
- •Pregnant and lactating women, as well as reproductive age patients who are unwilling to take contraceptive measures;
- •Patients who require treatment for merging with other malignant tumors;
- •History of pulmonary hemorrhage/hemoptysis ≥ grade 2 (defined as at least 2.5mL of bright red blood) within one month prior to the first administration;
- •Within 6 months prior to the first administration, there are arterial embolism, severe bleeding (excluding bleeding caused by surgery), and a tendency for severe bleeding;
- •Merge symptomatic brain metastases, meningeal metastases, spinal cord tumor invasion, and spinal cord compression syndrome;
- •Have used other clinical trial drugs within one month before the first administration;
- •The researchers have determined that patients who are not suitable to participate in this study.
研究组 & 干预措施
Research Scheme Experimental Group
Experimental
Three line treatment of advanced pancreatic cancer with regofinil combined with teripril monoclonal antibody and albumin paclitaxel
干预措施: Regorafenib combined with Toripalimab and Albumin paclitaxel (Drug)
结局指标
主要结局
(PFS)
时间窗: Dated from the first treatment with study medication to the first documented PD or death owing to any cause, whichever occurred first,assessed up to 60 months.
Progression-Free Survival
次要结局
- ORR(up to 60 months)
- OS(Dated from the date of first treatment with study medication to the date of death owing to any cause or censored on the date of last follow-up,assessed up to 60 months.)
研究者
Junjie Hang
Prof.
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
研究点 (1)
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