Efficacy of Stereotactic Body Radiotherapy (SBRT) Combined With Maintenance Therapy Compared to Maintenance Therapy Alone in Advanced Pancreatic Cancer
Efficacy of Stereotactic Body Radiotherapy (SBRT) Combined With Maintenance Therapy Compared to Maintenance Therapy Alone in Advanced Pancreatic Cancer: A Multi-center, Randomized Controlled Phase II Clinical Trial
研究概览
地位
条件
详细说明
Pancreatic cancer is one of the most aggressive malignancies, and most patients are diagnosed at an advanced stage, making them ineligible for surgery. Despite systemic chemotherapy being the standard treatment for advanced pancreatic cancer, the prognosis remains poor, with median survival often less than one year. The addition of radiotherapy has shown some promise in improving outcomes, particularly in the setting of local control.
This Phase II, multicenter, randomized controlled trial evaluates the combination of Stereotactic Body Radiotherapy (SBRT) with maintenance therapy versus maintenance therapy alone in patients with advanced pancreatic cancer. SBRT offers a high dose of radiation with minimal damage to surrounding healthy tissues, potentially enhancing tumor control while preserving immune function, a key challenge in pancreatic cancer treatment. Moreover, SBRT has shown potential in stimulating anti-tumor immune responses, thus converting "cold" tumors into "hot" tumors that may respond better to subsequent therapies.
Patients eligible for this trial will have completed at least four months of first-line chemotherapy, achieving stable disease (SD) or partial response (PR) according to RECIST 1.1 criteria. After completion of the chemotherapy, they will be randomized into two groups: the experimental group will receive SBRT in addition to maintenance chemotherapy, while the control group will receive maintenance chemotherapy alone. The chemotherapy regimen will be based on the patient's first-line treatment.
The study will evaluate the primary endpoint of one-year overall survival (OS) rate, alongside secondary endpoints including overall survival, progression-free survival (PFS), local control rate (LCR), and adverse event (AE) rates. In addition, exploratory endpoints include identifying potential biomarkers associated with the anti-tumor efficacy of SBRT and maintenance therapy. These biomarkers include PD-L1 expression, tumor mutational burden (TMB), and changes in immune cell subsets in blood and tumor tissue.
The results of this study will provide valuable insights into the combination of SBRT and maintenance chemotherapy as a potential treatment option for advanced pancreatic cancer, which may lead to improved survival outcomes and a better understanding of the biological mechanisms that drive treatment response.
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Jinbo Yue, doctor
- 电话号码：0531-67626442
- 邮箱：jbyue@sdfmu.edu.cn
学习地点
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Shandong
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Jinan、Shandong、中国、250021
- 招聘中
- Shandong Cancer Hospital And Institute
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接触：
- Jinbo Yue, Doctor
- 邮箱：jbyue@sdfmu.edu.cn
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age 18 to 70 years old.
- Histologically or cytologically confirmed diagnosis of pancreatic - adenocarcinoma.
- No prior radiation therapy for pancreatic cancer.
- At least one measurable lesion of the primary pancreatic tumor as per RECIST 1.1 criteria, eligible for SBRT.
- Completion of first-line chemotherapy with stable disease (SD) or partial response (PR) after ≥4 months of treatment.
- ECOG performance status of 0-2.
- Expected survival of ≥3 months.
- Adequate organ function within 14 days prior to enrollment:
- Hemoglobin (Hb) ≥ 90 g/L
- Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L
- Platelets (PLT) ≥ 75×10⁹/L
- Total bilirubin ≤ 1.5× ULN or direct bilirubin ≤ ULN
- ALT/AST ≤ 2.5× ULN
- ALP ≤ 2.5× ULN
- Serum creatinine ≤ 1.5× ULN or calculated creatinine clearance ≥ 40 mL/min
- Urine protein < 2+ (if ≥2+ on dipstick, 24-hour urine protein must be < 2g)
- No use of systemic corticosteroids in the last 7 days prior to enrollment (physiological corticosteroid replacement is allowed).
- Women of childbearing potential and men must use effective contraception during the study and for 12 months following treatment completion.
- Voluntary participation with signed informed consent.
- Ability to comply with the study schedule.
Exclusion Criteria:
- Currently participating in any interventional clinical trial or having received other investigational drugs or devices within 4 weeks prior to enrollment.
- Peritoneal metastasis.
- Known active central nervous system (CNS) metastasis and/or carcinomatous meningitis.
- Receiving systemic corticosteroid treatment within 7 days prior to enrollment (except for physiological doses).
- Active, untreated hepatitis B (HBsAg positive and detectable HBV-DNA) or active hepatitis C infection (HCV antibody positive and detectable HCV RNA).
- Pregnant or breastfeeding women.
- Any severe or uncontrolled systemic disease, including:
- QTc interval ≥ 480 ms
- Unstable angina
- NYHA class III-IV congestive heart failure
- Arterial thromboembolism (MI, unstable angina, stroke, TIA) within 6 months prior to enrollment
- Uncontrolled hypertension (systolic BP ≥ 150 mmHg, diastolic BP ≥ 90 mmHg)
- Active pulmonary tuberculosis, severe infections, or other uncontrolled diseases
- Active gastrointestinal perforation, fistula, or bowel obstruction.
- Inadequately controlled diabetes (fasting blood glucose > 10 mmol/L).
- History of mental illness preventing compliance with treatment.
- Active bleeding or significant coagulation abnormalities within the last 30 days.
- Previous gastrointestinal perforation or other serious gastrointestinal conditions in the past 6 months.
- Participation in other trials that may interfere with this study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Stereotactic Body Radiotherapy (SBRT) with maintenance therapy
Patients eligible for this trial will have completed at least four months of first-line chemotherapy, achieving stable disease (SD) or partial response (PR) according to RECIST 1.1 criteria.
After completion of the chemotherapy, the experimental group will receive SBRT in addition to maintenance chemotherapy
|
Patients eligible for this trial will have completed at least four months of first-line chemotherapy, achieving stable disease (SD) or partial response (PR) according to RECIST 1.1 criteria.
After completion of the chemotherapy, they will be randomized into two groups: the experimental group will receive SBRT in addition to maintenance chemotherapy.
The chemotherapy regimen will be based on the patient's first-line treatment.
|
|
实验性的：maintenance therapy
Patients eligible for this trial will have completed at least four months of first-line chemotherapy, achieving stable disease (SD) or partial response (PR) according to RECIST 1.1 criteria.
After completion of the chemotherapy, the control group will receive maintenance chemotherapy alone.
|
Patients eligible for this trial will have completed at least four months of first-line chemotherapy, achieving stable disease (SD) or partial response (PR) according to RECIST 1.1 criteria.
After completion of the chemotherapy, they will be randomized into two groups: the control group will receive maintenance chemotherapy alone.
The chemotherapy regimen will be based on the patient's first-line treatment.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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1-Year Overall Survival (OS) Rate
大体时间：12 months
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The proportion of patients who are alive at 12 months from the start of the study.
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12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall Survival (OS)
大体时间：From the date of diagnosis until the date of death from any cause, whichever occurs first, assessed up to 24 months.
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The time from diagnosis to death from any cause.
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From the date of diagnosis until the date of death from any cause, whichever occurs first, assessed up to 24 months.
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Progression-Free Survival (PFS)
大体时间：From the start of treatment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
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The time from the start of treatment to disease progression or death.
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From the start of treatment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
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Local Control Rate (LCR)
大体时间：Assessed at the end of treatment and at follow-up visits, up to 24 months.
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The proportion of patients whose tumors are controlled at the primary site after treatment.
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Assessed at the end of treatment and at follow-up visits, up to 24 months.
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Adverse Event (AE) Rate
大体时间：Monitored throughout the treatment period, and safety follow-up will continue 30 days after the last dose or until the start of a new anti-cancer treatment, whichever occurs first
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The frequency of all adverse events occurring during the treatment period.
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Monitored throughout the treatment period, and safety follow-up will continue 30 days after the last dose or until the start of a new anti-cancer treatment, whichever occurs first
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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