NCT05448183Unknown2 期
A Single-arm, Open-label, Multi-center Phase II Clinical Study to Evaluate the Safety and Efficacy of Toripalimab Injection Combined With TACE in the Treatment of Extrahepatic Cholangiocarcinoma
Xuhua Duan1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2022年6月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
This is an open-label, single-arm, multicenter phase II clinical study to preliminarily observe and evaluate the efficacy and safety of Toripalimab combined with TACE in the treatment of extrahepatic cholangiocarcinoma.
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
- 是
入选标准
- •Age > 18 years and < 75 years
- •both men and women
- •ECOG performance status score 0-2 points
- •Child-Pugh score ≤ 7 points
- •Expected survival ≥ 12 weeks
- •Patients with histologically or cytologically confirmed extrahepatic cholangiocarcinoma, patients with obstructive jaundice need to return to normal after drainage
- •At least one measurable lesion [spiral CT scan ≥ 10 mm (CT scan slice thickness no greater than 5 mm)] (RECIST Version 1.1)
- •Vital organ function meets the following requirements: a. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; b. Platelets ≥ 75 × 109/L; c. Hemoglobin ≥ 8 g/dL; d. Serum albumin ≥ 2.8 g/dL; e. Bilirubin ≤ 3 ULN, ALT/AST ≤ 2.5 UILN; if there is liver metastasis, ALT/AST ≤ 5 times ULN; f. Creatinine clearance ≥ 50 mL/min (Cockcroft-Gault, see Appendix III); g. Normal thyroid function. h. Adequate cardiac function, 2-dimensional cardiac ultrasound examination of the score (LVEF) > 50%
- •No history of serious drug allergy
- •Women of childbearing age must have taken reliable contraceptive measures or have a pregnancy test before enrollment
- •The subject voluntarily participates in this study. Sign the informed consent form, with good compliance and cooperation in follow-up
排除标准
- •Known to be allergic to recombinant humanized PD-1 monoclonal antibody drugs and their components
- •Presence of any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; complete remission of asthma in childhood, no intervention after adulthood can be included; patients with asthma requiring bronchodilators for medical intervention can not be included)
- •Patients are using immunosuppressive agents, or systemic hormone therapy to achieve the purpose of immunosuppression (dose > 10 mg/day prednisone or other effective hormones), and continue to use 2 times before enrollment
- •Pregnant or lactating women
- •Other malignant tumors have been diagnosed within 5 years before the first use of the study drug, except for effectively treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma and/or effectively resected in situ cervical cancer and/or breast cancer
- •Patients prone to infection and poor blood glucose control
- •Incomplete important imaging examination and incomplete record of adverse reactions
- •Previous surgery, chemotherapy, targeted, radiotherapy and immune-related therapy
- •Other conditions that the investigator judges may affect the conduct of the clinical study and the judgment of the study results
研究组 & 干预措施
Toripalimab combined withTACE
Experimental
干预措施: Toripalimab, Gemcitabine,Oxaliplatin (Drug)
结局指标
主要结局
Progression-free survival
时间窗: Up to 1 year
PFS is defined as time from the start of treatment to progression of disease or death.
次要结局
- Disease control rate(Up to 1 year)
- Objective response rate(Up to 1 year)
研究者
Xuhua Duan
Associate chief physician
The First Affiliated Hospital of Zhengzhou University
研究点 (1)
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