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

NCT ID: NCT06195254

Last Updated: 2024-01-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 19 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2023-12-15

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.

Conditions

Stereotactic Body Radiotherapy; PD-1 Inhibitors; Pancreatic Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Stereotactic body radiotherapy (SBRT)

Intervention Type: RADIATION

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

PD-1 blocking antibody

Intervention Type: DRUG

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.

Interventions

Stereotactic body radiotherapy (SBRT)

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

Intervention Type: RADIATION

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junjie Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

Junjie Wang

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

preSPARK-1

Identifier Type: -

Identifier Source: org_study_id