Stereotactic Body Radiotherapy Combined With PD-1 Blockers for Locally Advanced or Locally Recurrent Pancreatic Cancer

Peking University

Status: Completed

Conditions: PD-1 Inhibitors; Stereotactic Body Radiotherapy; Pancreatic Cancer

Treatments: Drug: PD-1 blocking antibody; Radiation: Stereotactic body radiotherapy (SBRT)

Study type: Observational

Funder types: Other

Identifiers

NCT06195254

preSPARK-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

19 participants in 1 patient group

SBRT+PD-1 blockers

Description:

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.

Treatment:

Radiation: Stereotactic body radiotherapy (SBRT)

Drug: PD-1 blocking antibody