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Efficacy of Stereotactic Body Radiotherapy (SBRT) Combined With Maintenance Therapy Compared to Maintenance Therapy Alone in Advanced Pancreatic Cancer

2026년 5월 19일 업데이트: Jinbo Yue, Shandong Cancer Hospital and Institute

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

This is a Phase II, multicenter, randomized controlled trial to assess the efficacy of Stereotactic Body Radiotherapy (SBRT) in combination with maintenance therapy in patients with advanced pancreatic cancer. The aim is to compare the efficacy of SBRT combined with maintenance therapy versus maintenance therapy alone. The primary outcome is the overall survival (OS) of patients, with secondary endpoints including progression-free survival (PFS), response rates, and quality of life assessments. The study will involve patients with unresectable pancreatic adenocarcinoma who are receiving chemotherapy and have stable disease. The hypothesis is that SBRT, by improving local control, can enhance the benefit of ongoing maintenance therapy and lead to better overall survival outcomes in this patient group.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

24

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 중국
    • Shandong
      • Jinan, Shandong, 중국, 250021
        • 모병
        • Shandong Cancer Hospital and Institute
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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
방사능: 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, 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.
실험적: 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.
의약품: 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, 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
1-Year Overall Survival (OS) Rate
기간: 12 months
The proportion of patients who are alive at 12 months from the start of the study.
12 months

2차 결과 측정

결과 측정
측정값 설명
기간
Overall Survival (OS)
기간: 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.
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)
기간: 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.
Local Control Rate (LCR)
기간: Assessed at the end of treatment and at follow-up visits, up to 24 months.
The proportion of patients whose tumors are controlled at the primary site after treatment.
Assessed at the end of treatment and at follow-up visits, up to 24 months.
Adverse Event (AE) Rate
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Shandong Cancer Hospital and Institute

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 8월 14일

기본 완료 (추정된)

2028년 8월 14일

연구 완료 (추정된)

2028년 8월 14일

연구 등록 날짜

최초 제출

2026년 4월 27일

QC 기준을 충족하는 최초 제출

2026년 5월 19일

처음 게시됨 (실제)

2026년 5월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 19일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • SDZLEC2025-282-02

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Stereotactic Body Radiotherapy (SBRT) with maintenance therapy에 대한 임상 시험

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