Pancreatic Cancer Non-resectablePhase 2NCT07600268
Efficacy of Stereotactic Body Radiotherapy (SBRT) Combined With Maintenance Therapy Compared to Maintenance Therapy Alone in Advanced Pancreatic Cancer
A Phase 2 study testing Stereotactic Body Radiotherapy (SBRT) with maintenance therapy and Maintenance therapy in people with Pancreatic Cancer Non-resectable, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatic Cancer Non-resectable
- What is being tested?
- Stereotactic Body Radiotherapy (SBRT) with maintenance therapy and Maintenance therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 14 Aug 2025to 14 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong Cancer Hospital and Institute
Jinan, Shandong, 250021
Jinbo Yue, Doctor, jbyue@sdfmu.edu.cn
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Pancreatic Cancer Non-resectable
- Being tested
- Stereotactic Body Radiotherapy (SBRT) with maintenance therapy, Maintenance therapy
- Keywords
- Pancreatic cancer, Stereotactic Body Radiotherapy, maintenance therapy, chemotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiotherapy (SBRT) with maintenance therapyRadiation
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.
Maintenance therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) with maintenance therapy | Experimental | 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 Receives: Radiation: Stereotactic Body Radiotherapy (SBRT) with maintenance therapy |
| maintenance therapy | Experimental | 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. Receives: Drug: Maintenance therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Year Overall Survival (OS) Rate
The proportion of patients who are alive at 12 months from the start of the study.
Measured: 12 months
Secondary outcomes (4)
Overall Survival (OS)
The time from diagnosis to death from any cause.
Measured: 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)
The time from the start of treatment to disease progression or death.
Measured: 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)
The proportion of patients whose tumors are controlled at the primary site after treatment.
Measured: Assessed at the end of treatment and at follow-up visits, up to 24 months.
Adverse Event (AE) Rate
The frequency of all adverse events occurring during the treatment period.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start14 Aug 2025
- Primary completion14 Aug 2028 (estimated)
- Study completion14 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer Non-resectableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinbo Yue, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600268
- Sponsor's protocol ID
- SDZLEC2025-282-02
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07600268
- Acronym / sponsor ID
- SDZLEC2025-282-02
- Conditions
- Pancreatic Cancer Non-resectable
- Keywords
- Pancreatic cancer, Stereotactic Body Radiotherapy, maintenance therapy, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 14 Aug 2028 (estimated)
- Study completion
- 14 Aug 2028 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) with maintenance therapy | Experimental | Radiation: Stereotactic Body Radiotherapy (SBRT) with maintenance therapyPatients 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 |
| maintenance therapy | Experimental | Drug: Maintenance therapyPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (19 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) with maintenance therapyPatients 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. | Radiation | Stereotactic Body Radiotherapy (SBRT) with maintenance therapy |
| Maintenance therapyPatients 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. | Drug | maintenance therapy |
Primary outcome
1-Year Overall Survival (OS) Rate
Time frame: 12 months
The proportion of patients who are alive at 12 months from the start of the study.
4 secondary outcomes
Overall Survival (OS)
Time frame: 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)
Time frame: 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)
Time frame: Assessed at the end of treatment and at follow-up visits, up to 24 months.
Adverse Event (AE) Rate
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Body Radiotherapy (SBRT) with maintenance therapy and Maintenance therapy in people with Pancreatic Cancer Non-resectable, run by Shandong Cancer Hospital and Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinbo Yue, Doctor (0531-67626442, jbyue@sdfmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Year Overall Survival (OS) Rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.