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Completed

NCT Number: NCT06195254

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Junjie Wang

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • LRPC confirmed by pathologic or imaging diagnosis and LAPC confirmed by pathology;
  • disease size ≥1 cm;
  • KPS≥70;
  • 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.

Treatment and study plan

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 antibody

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.

Primary outcomes

  1. progression-free survival (PFS)

    Time frame: 12 months

    PFS was defined as the time from SBRT to disease progression

Secondary outcomes

  1. local progression-free survival (LPFS)

    Time frame: 12 months

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

  2. Overall survival (OS)

    Time frame: 18 months

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

  3. Adverse Events (AEs)

    Time frame: 18 months

    All kinds of side effects.

  4. Pain relief rate (PRR)

    Time frame: 18 months

    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.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 8, 2024
Registry last updated
Jan 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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