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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Jinbo Yue, doctor
- 電話番号：0531-67626442
- メール：jbyue@sdfmu.edu.cn
研究場所
-
-
Shandong
-
Jinan、Shandong、中国、250021
- 募集
- Shandong Cancer Hospital And Institute
-
コンタクト：
- Jinbo Yue, Doctor
- メール：jbyue@sdfmu.edu.cn
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
1-Year Overall Survival (OS) Rate
時間枠：12 months
|
The proportion of patients who are alive at 12 months from the start of the study.
|
12 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall Survival (OS)
時間枠：From the date of diagnosis until the date of death from any cause, whichever occurs first, assessed up to 24 months.
|
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.
|
|
Progression-Free Survival (PFS)
時間枠：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.
|
The time from the start of treatment to disease progression or death.
|
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)
時間枠：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
時間枠：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
|
The frequency of all adverse events occurring during the treatment period.
|
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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- SDZLEC2025-282-02
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