Endoscopic Ultrasound-guided Intratumoral Iodine125-Seeds Implantation Combined With Gem/Nab-P Chemotherapy Versus Gem/Nab-P Alone for Metastatic Pancreatic Carcinoma: a Randomized, Controlled, Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The goal of this clinical trial is to evaluate the clinical efficacy and safety of endoscopic ultrasonography (EUS)-guided radioactive iodine 125 seeds in combination with AG regimen chemotherapy for the treatment of metastatic pancreatic cancer. The main questions it aims to answer are:
- whether the combination of minimally invasive endoscopy-guided local radiation therapy with chemotherapy may improve overall survival
- the adverse events of the combination therapy Participants will receive the implantation of radioactive seeds under EUS guide. 48h after implantation, chemotherapy with Gem/nab-P given on days 1 and 8 of each 21-day cycle will be conducted.
Researchers will compare the I125+AG group with the group that takes AG chemotherapy alone to see if the overall survival can be improved.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
Patients will be randomly assigned(1:1) to the two treatment groups by an independent staff who is not involved in the treatment. The endoscopist and patient are not masked because they exactly know whether EUS-guided implantation is performed or not. Survival will be assessed by blinded researchers during follow-up.
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
- •(Before the trial, subjects must meet all of the requirements listed below in order to be enrolled)
- •18 to 80 years old;
- •Stage IV pancreatic ductal adenocarcinoma with distant metastases confirmed by clinical, imaging, and pathology, and the primary and metastatic mass can be measured on imaging.
- •No treatment history of chemotherapy, radiotherapy, or surgery
- •Expected survival > 6 months
- •ECGO score of 0-2
- •Eligible for chemotherapy (white blood cell > 3.5×109/L, neutrophil value > 1.5×109/L, hemoglobin > 80g/L, platelets > 100×109/L, albumin > 25g/L, alanine aminotransferase or aspartate aminotransferase ≤ 3 times the upper limit of normal and total bilirubin level ≤ 34.2umol/L, creatinine < 176.8 umol/L, normal ECG)
- •Signed written informed consent;
排除标准
- •Contraindication of EUS-guide procedure or technical infeasibility (e.g.,coagulation disorder, anatomical changes, large vessels along the puncture path)
- •Pregnant or breastfeeding
- •Presence of brain metastases
- •Presence of deep vein thrombosis or pulmonary embolism
- •Presence of HIV, HBV, HCV infection or other uncontrollable active infection
- •Hypersensitivity to chemotherapy drugs
- •History of other malignancies within 5 years
- •Peripheral neuropathy or interstitial lung disease within 5 years
- •Patient is enrolled in any other clinical protocol or investigational trial.
研究组 & 干预措施
I125-AG
Participants will receive the implantation of radioactive seeds under EUS guide. 48h after implantation, chemotherapy with Gemcitabine 1000mg/m2 plus albumin paclitaxel 125mg/m2 given on days 1 and 8 of each 21-day cycle will be conducted.
干预措施: Iodine125-Seeds implantation (Procedure)
I125-AG
Participants will receive the implantation of radioactive seeds under EUS guide. 48h after implantation, chemotherapy with Gemcitabine 1000mg/m2 plus albumin paclitaxel 125mg/m2 given on days 1 and 8 of each 21-day cycle will be conducted.
干预措施: Gem/nab-P Chemotherapy (Drug)
AG
Participants receive chemotherapy alone. Gemcitabine 1000mg/m2 plus albumin paclitaxel 125mg/m2 given on days 1 and 8 of each 21-day cycle.
干预措施: Gem/nab-P Chemotherapy (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: 48 months
OS is defined as the time from the date of randomization to the date of death (any cause). Patients who are alive will be censored at the last known time that the patient was alive.
次要结局
- Overall Response Rate (ORR)(48 months)
- CA19-9 response(48 months)
- Progression-free survival (PFS)(48 months)
- Incidence and severity of Adverse events (AEs)(48 months)
- Visual analog scale (VAS)(48 months)
- Metabolic response(from baseline to the end of 2nd chemotherapy cycle)
研究者
Zhaoshen Li
Department of Gastroenterology, Changhai Hospital
Changhai Hospital