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

NCT06195254 | Completed DMC

• 1 other identifier: preSPARK-1
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Stereotactic Body Radiotherapy; PD-1 Inhibitors; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

  PFS was defined as the time from SBRT to disease progression

  12 months

Secondary Outcomes (4)

• local progression-free survival (LPFS)

  12 months

• Overall survival (OS)

  18 months

• Adverse Events (AEs)

  18 months

• Pain relief rate (PRR）

  18 months

Study Arms (1)

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.

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

Interventions

Stereotactic body radiotherapy (SBRT) RADIATION

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

SBRT+PD-1 blockers

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.

SBRT+PD-1 blockers

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients, diagnosed with 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Junjie Wang

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Junjie Wang, M.D.

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: December 1, 2020
• Primary Completion: May 21, 2023
• Study Completion: December 15, 2023
• Last Updated: January 8, 2024

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Allways.
• Access Criteria: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Locations

CN (1)