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

N/ACompletedNCT06195254

Peking University Third Hospital19 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Stereotactic Body Radiotherapy PD-1 Inhibitors Pancreatic Cancer

Interventions

Stereotactic body radiotherapy (SBRT)RADIATION

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

PD-1 blocking antibodyDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

progression-free survival (PFS)

PFS was defined as the time from SBRT to disease progression

Time frame: 12 months

Secondary Outcomes

local progression-free survival (LPFS)

LPFS was defined as the time from SBRT to local progression.

Time frame: 12 months

Overall survival (OS)

OS was defined as the time from SBRT to death from any cause.

Time frame: 18 months

Adverse Events (AEs)

All kinds of side effects.

Time frame: 18 months

Pain relief rate (PRR）

The numeric rating scale (NRS) was used to evaluate the pain levels before and after treatment and the pain relief rate was calculated from the patients achieving pain The numeric rating scale (NRS) was used to evaluate the pain levels before and after treatment and the pain relief rate was calculated from the patients achieving pain The numeric rating scale (NRS) was used to evaluate the pain levels before and after treatment and the pain relief rate was calculated from the patients achieving pain relief after SBRT.

Time frame: 18 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes