Endoscopic Ultrasound-Guided Loco-regional Chemotherapy Injection as Adjuvant Therapy for Locally Advanced Pancreatic Cancer: A Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- compare patients with locally advanced pancreatic cancer treated with EUS guided injection of gemcitabine plus systemic chemotherapy to those treated with the standard systemic chemotherapy alone, regarding to(progression -freesurvival and response rate)
研究概览
简要总结
this is a randomized controlled trial aims to compare between patients with locally advanced pancreatic cancer treated with EUS-guided injection of gemcitabine in addition to systemic chemotherapy, versus those who treated with the standard systemic chemotherapy alone, regarding to(progression -free survival and response rate).
Researchers will compare Arm A: patients received EUS-FNI of gemcitabine plus standard systemic chemotherapy to Arm B : patients receiving the standard systemic chemotherapy alone.
详细描述
Pancreatic cancer (PC) is the seventh leading cause of global cancer deaths in the developed countries, and the third most common in the USA. Based on GLOBOCAN 2020 estimates, PC has ranked the 12th most common cancer in the world.
In Egypt, according to incidence rate; the PCs are the 11th most common malignancies and represent 2.2% of all cancers incidence. While according to mortality rate, PCs are the 8th of all deaths caused by cancer and represent 3.2%.
Pancreatic cancers are categorized into two main types based on the cell of origin: exocrine cancers, which are the most common (over 95% of cases) and begin in the cells lining the ducts, with adenocarcinoma being the most frequent type, and endocrine cancers (also called pancreatic neuroendocrine tumors) which are less common and start in hormone-producing endocrine cells.
according to National Comprehensive Cancer Network (NCCN 2025) resectability criteria: Locally advanced pancreatic cancer (stage 3) is defined as unresectable ( at the time of diagnosis) non-metastasized pancreatic cancer, but extend to the nearby blood vessels (solid tumor contact >180degree with the SMA or CA) .
Gemcitabine-based chemotherapy regimens have become the standard of care in LAPC. They have increased the chances of converting LAPC to resectable tumors . but chemoresistance to gemcitabine is increasing due insufficient drug delivery due to decreased microvascularity and stroma-induced chemoresistance (Desmoplastic Stroma).
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old.
- •Patients recently diagnosed to have pancreatic adenocarcinoma based on histopathological examination.
- •Locally advanced potentially resectable pancreatic cancer . .Eastern Cooperative Oncology Group performance status of 0 to
- •.Signed informed consent.
排除标准
- •Age < 18 years old.
- •Metastatic pancreatic cancer.
- •prior pancreatic surgery or chemotherapy or radiotherapy. concurrent or prior malignancy. coexistent medical condition precluding protocol therapy.
研究组 & 干预措施
Arm A
endoscopic ultrasound local chemotherapeutic drug injection in addition to systemic chemotherapy
干预措施: endoscopic ultrasonograhy guided chemptherapy injection (Drug)
B
patients who recieve chemotherapeutic drug only
结局指标
主要结局
compare patients with locally advanced pancreatic cancer treated with EUS guided injection of gemcitabine plus systemic chemotherapy to those treated with the standard systemic chemotherapy alone, regarding to(progression -freesurvival and response rate)
时间窗: every one month
The primary outcome of this study is to compare the progression-free survival between patients with locally advanced pancreatic cancer who receive EUS-guided injection of gemcitabine plus systemic chemotherapy (Arm A) and those who receive standard systemic chemotherapy alone (Arm B). Progression-free survival is defined as the time from randomization to the first documented progression of disease (as per RECIST criteria) or death, whichever occurs first. The secondary outcome will be the comparison of the response rate between the two treatment arms. Objective response rate will be measured as the proportion of patients who achieve either complete response (CR) or partial response (PR) to treatment, according to RECIST criteria. By evaluating both progression-free survival and response rate, the trial aims to determine whether the addition of EUS-guided gemcitabine injection enhances the effectiveness of systemic chemotherapy in treating locally advanced pancreatic cancer
次要结局
未报告次要终点
研究者
Alshaimaa Eid
assiut city- assiut university street
Assiut University