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

NCT07600268 | Recruiting Phase 2

• 1 other identifier: SDZLEC2025-282-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pancreatic Cancer Non-resectable

Keywords

Pancreatic cancer; Stereotactic Body Radiotherapy; maintenance therapy; chemotherapy

Outcome Measures

Primary Outcomes (1)

• 1-Year Overall Survival (OS) Rate

  The proportion of patients who are alive at 12 months from the start of the study.

  12 months

Secondary Outcomes (4)

• Overall Survival (OS)

  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)

  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)

  Assessed at the end of treatment and at follow-up visits, up to 24 months.

• Adverse Event (AE) Rate

  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

Study Arms (2)

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

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.

Drug: Maintenance therapy

Interventions

Stereotactic Body Radiotherapy (SBRT) with maintenance therapy RADIATION

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.

Stereotactic Body Radiotherapy (SBRT) with maintenance therapy

Maintenance therapy DRUG

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.

maintenance therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, 250021, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiosurgery; Maintenance

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Health Care Facilities Workforce and Services

Central Study Contacts

Jinbo Yue, Doctor

CONTACT

0531-67626442; jbyue@sdfmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Radiation Oncology Department

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 20, 2026
• Study Start: August 14, 2025
• Primary Completion (Estimated): August 14, 2028
• Study Completion (Estimated): August 14, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)