NCT06844773尚未招募不适用
A Single-center, Prospective, Observational Cohort Study of Chemoradiotherapy in Elderly Patients with Locally Advanced Pancreatic Cancer (70+).
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1-year survival rate
研究概览
简要总结
The goal of this observational study is to learn about the therapeutic effects of chemoradiotherapy for older adults (age 70-85) with locally advanced pancreatic cancer. The main question it aims to answer is:
Does chemoradiotherapy represent an effective and safe treatment for older participants without radical surgery? Participants will sequentially receive combined chemotherapy followed by concurrent chemoradiotherapy and subsequent maintenance therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 70 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate and sign the informed consent form
- •Age 70-85 years old, life expectancy > 1 year and gender is not limited
- •Eastern Cooperative Oncology Group Physical Status Score (ECOG) physical state score<=1 point
- •Pathological or cytological confirmation of pancreatic ductal adenocarcinoma (including IPMN malignant transformation, acinar carcinoma, etc., excluding adenosquamous cell carcinoma and neuroendocrine carcinoma)
- •The clinical stage is stage III (locally advanced pancreatic cancer), and no radical surgery has been performed (bypass surgery is acceptable), or the patient has resectable pancreatic cancer, but cannot accept surgery or refuse surgery due to physical strength or concomitant diseases
- •Have not received any form of anti-tumor therapy before treatment, including systemic chemotherapy, interventional chemotherapy, high-energy focused ultrasound, radiotherapy, immunotherapy, molecular targeted therapy, and anti-tumor traditional Chinese medicine therapy
- •No serious hematological, cardiological, pulmonary function abnormalities and autoimmune deficiencies (refer to their respective diagnostic criteria)
- •Blood routine index: white blood cell (WBC) >=3.0 × 109/L; Absolute neutrophil count (ANC) >=1.5 × 109/L; Platelets (PLT) >=100 × 109/L; hemoglobin (Hgb) >=90 g/L
- •Blood biochemical indexes: AST (SGOT), ALT (SGPT) <=2.5 × upper limit of normal value (ULN); Total bilirubin (TBIL) < = ULN; Serum creatinine (CRE) <=1.5 × ULN
- •Coagulation function: prothrombin time (PT), international normalized ratio (INR) <=1.5 × ULN
- •Able to comply with the requirements of the study visit plan and other programs.
排除标准
- •Accompanied by malignant tumors of other systems
- •Received any form of anti-tumor therapy before treatment, including systemic chemotherapy, interventional chemotherapy, high-energy focused ultrasound, radiotherapy, immunotherapy, molecular targeted therapy, and anti-tumor traditional Chinese medicine therapy
- •Have used any other non-anti-tumor research drugs within 4 weeks before treatment
- •Combined with uncontrollable hypertension, diabetes, infection, etc.
- •Poor compliance, unable or unwilling to sign informed consent
- •Patients who are expected to be out of the observation period for 14 days or more during the treatment period.
结局指标
主要结局
1-year survival rate
时间窗: From the date of first therapy administration to one year later
To observe whether the 1-year survival rate of elderly patients with locally advanced pancreatic cancer treated with sandwich-like chemoradiotherapy modality was comparable to that of the historical data of the general adult population.
次要结局
- Toxicity and side effects and tolerability assessment(From the date of first therapy administration to within 90 days, up to 24 months)
- event-free survival throughout the enrolled subject population(From the date of first therapy administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.)
- the proportion of participants that completed chemoradiotherapy(From the date of first enrollment to the date of completion of follow-up of the last patient, up to 24 months.)
- the proportion ofparticipants that completed all planned courses(From the date of first enrollment to the date of completion of follow-up of the last patient, up to 24 months.)
- Objective response rate (ORR) tumor target lesions in the entire subject population all planned courses(From the date of first therapy administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.)
- Disease control rate (DCR) of tumor target lesions in the entire subject population all planned courses(From date of first therapy administration until the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to 24 months.)
研究者
研究点 (1)
Loading locations...
相似试验
终止
不适用
OLIF25™ /OLIF51™ StudyScoliosisDegenerative Disc DiseaseNCT02657421Medtronic Spinal and Biologics168
尚未招募
2 期
Clinical Study of Radiotherapy Combined With Nedaplatin Contrast and Cisplatin for the Treatment of Locally Advanced Head and Neck Squamous CarcinomaHead and Neck Squamous CarcinomaNCT05039606Guiyang Medical University164
招募中
不适用
Multicenter Cohort Study of ESD and Chemo-radiotherapy for High-risk Early-stage Esophageal CancerEsophagus CancerNCT06385717Second Affiliated Hospital, School of Medicine, Zhejiang University120
已完成
不适用
chronOS Inject in Proximal Tibial FracturesClosed Proximal Tibial Fracture AO-OTA 41Closed Proximal Tibial Fracture AO-OTA 42Closed Proximal Tibial Fracture Schatzker I - VINCT02056834Synthes GmbH36
已完成
不适用
An Observational Study of Radiotherapy After Injection of SpaceOAR HydrogelProstate CancerNCT05735652Boston Scientific Corporation14