A Retrospective Clinical Study of Stereotactic Body Radiotherapy Combined With PD-1 Blockers for Locally Advanced or Locally Recurrent Pancreatic Carcinoma.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- progression-free survival (PFS)
Study Overview
Brief Summary
The goal of this observational study is to investigate the efficacy and safety of stereotactic body radiotherapy combined with PD-1 blockers for LAPC and LRPC. The patients, diagnosed with locally advanced pancreatic cancer (LAPC) or locally recurrent pancreatic cancer (LRPC). LRPC or LAPC, undergoing SABT and PD-1 blockers in our hospital from December 2020 to April 2023 were reviewed consecutively. All patients provided written informed consent before treatment. The study was conducted in accordance with the Declaration of Helsinki, and it was approved by the Institutional Ethics Committee of Peking University Third Hospital.
Detailed Description
The goal of this observational study is to investigate the efficacy and safety of stereotactic body radiotherapy (SBRT) combined with PD-1 blockers for LAPC and LRPC. The patients, diagnosed with locally advanced pancreatic cancer (LAPC) or locally recurrent pancreatic cancer (LRPC). LRPC or LAPC, undergoing SBRT and PD-1 blockers in our hospital from December 2020 to April 2023 were reviewed consecutively. The schedule of SBRT is 25 to 50 Gy in 5 fractions and the PD-1 blockers are monoclonal antibodies targeted to PD-1 molecules on the T lymphocytes.
All patients provided written informed consent before treatment. The study was conducted in accordance with the Declaration of Helsinki, and it was approved by the Institutional Ethics Committee of Peking University Third Hospital.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •LRPC confirmed by pathologic or imaging diagnosis and LAPC confirmed by pathology;
- •disease size ≥1 cm;
- •adequate hematological reserves, hepatic function, renal function and heart function;
- •expected survival > 3 months.
Exclusion Criteria
- •unconfirmed mass;
- •The upper abdomen was previously treated with radiotherapy;
- •the patients previously underwent immunotherapy of PD-1 or PD-L1 monoclonal antibody;
- •a history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency or other immune-related conditions requiring long-term oral hormone therapy;
- •patients with active infectious disease, trauma and severe wounds;
- •patients with any mental disorder;
- •patients with other somatic comorbidities of clinical concern;
- •pregnancy and lactation.
Arms & Interventions
SBRT+PD-1 blockers
pembrolizumab (200 mg every 3 weeks), carelizumab (200 mg every 3 weeks), tislelizumab (200 mg every 3 weeks), sintilimab (200 mg every 3 weeks), zimberelimab (240 mg every 3 weeks) until the tumor progressed or the side effects became intolerable.
Intervention: Stereotactic body radiotherapy (SBRT) (Radiation)
SBRT+PD-1 blockers
pembrolizumab (200 mg every 3 weeks), carelizumab (200 mg every 3 weeks), tislelizumab (200 mg every 3 weeks), sintilimab (200 mg every 3 weeks), zimberelimab (240 mg every 3 weeks) until the tumor progressed or the side effects became intolerable.
Intervention: PD-1 blocking antibody (Drug)
Outcomes
Primary Outcomes
progression-free survival (PFS)
Time Frame: 12 months
PFS was defined as the time from SBRT to disease progression
Secondary Outcomes
- Overall survival (OS)(18 months)
- Adverse Events (AEs)(18 months)
- local progression-free survival (LPFS)(12 months)
- Pain relief rate (PRR）(18 months)