Clinical trial

A Retrospective Clinical Study of Stereotactic Body Radiotherapy Combined With PD-1 Blockers for Locally Advanced or Locally Recurrent Pancreatic Carcinoma.

NCT06195254

Name

preSPARK-1

Description

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.

Trial arms

Trial start

2020-12-01

Estimated PCD

2023-05-21

Trial end

2023-12-15

Status

Completed

Treatment

Stereotactic body radiotherapy (SBRT)

All the patients first received SBRT with the dose of 25Gy up to 50Gy in five fractions.

Arms:

SBRT+PD-1 blockers

PD-1 blocking antibody

All the patients first received SBRT with the dose of 25Gy up to 50Gy in five fractions and then received the treatment of PD-1 blockers including 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.

Arms:

SBRT+PD-1 blockers

Size

Primary endpoint

progression-free survival (PFS)

12 months

Eligibility criteria

Inclusion Criteria: 1. LRPC confirmed by pathologic or imaging diagnosis and LAPC confirmed by pathology; 2. disease size ≥1 cm; 3. KPS≥70; 4. adequate hematological reserves, hepatic function, renal function and heart function; 5. expected survival \> 3 months. Exclusion Criteria: 1. unconfirmed mass; 2. The upper abdomen was previously treated with radiotherapy; 3. the patients previously underwent immunotherapy of PD-1 or PD-L1 monoclonal antibody; 4. a history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency or other immune-related conditions requiring long-term oral hormone therapy; 5. patients with active infectious disease, trauma and severe wounds; 6. patients with any mental disorder; 7. patients with other somatic comorbidities of clinical concern; 8. pregnancy and lactation.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 19, 'type': 'ACTUAL'}}

Updated at

2024-01-08

1 organization

1 drug

3 indications

Organization

Peking University Third Hospital

Drug

anti-PD-1 antibody

Indication

Stereotactic Body Radiotherapy

Indication

PD-1 Inhibitors

Indication

Pancreatic Cancer