跳至主要内容
临床试验/jRCT2032220428
jRCT2032220428招募中不适用

A Randomized Controlled Study of Suizenji in Patients with Unresectable Pancreatic Cancer

SONIRE Therapeutics Inc.0 个研究点目标入组 90 人开始时间: 2023年1月31日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
90
主要终点
-

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized Controlled Trial
干预模型
Parallel Assignment
主要目的
Treatment Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
20age old over 至 No limit(—)
性别
All

入选标准

  • (1) Ages 20 years and over.
  • (2) Unresectable pancreatic cancer (including metastatic pancreatic cancer) who are refractory or intolerant to first-line chemotherapy. Any first-line chemotherapy is acceptable.
  • (3) Target treatment tumor is located in the pancreas, and the target tumor can be visualized with ultrasound echography and can also be treated by high-intensity focused ultrasound.
  • (4) Has primary tumor site of measurable lesion according to RECIST guidelines version 1.1
  • (5) ECOG performance status of 0 to 2.

排除标准

  • (1) Active multiple cancers that require treatment.
  • (2) Suspected gastrointestinal invasion of the primary tumor based on CT scan.
  • (3) Obstructive jaundice. However, patients who have a bile duct stent placed for obstructive jaundice by the time of allocation may be enrolled.
  • (4) Child-Pugh Classification B or C liver failure due to liver metastases.
  • (5) Tumor embolization in the veins surrounding the pancreas.
  • (6) Cystic component within the pancreatic cancer.
  • (7) Peritoneal dissemination.
  • (8) Pleural effusion or ascites with poorly controlled
  • (9) Contraindications to the use of secondary chemotherapy used in this study.

结局指标

主要结局

-

Overall Survival

次要结局

未报告次要终点

研究者

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