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

Completed

• Conditions: Pancreatic Cancer; Stereotactic Body Radiotherapy; PD-1 Inhibitors
• Interventions: Radiation: Stereotactic body radiotherapy (SBRT); Drug: PD-1 blocking antibody

• Registration Number: NCT06195254
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Status Verified: 2020-12
• Study Start: 2020-12-01
• Primary Completion: 2023-05-21
• Study Completion: 2023-12-15
• Study First Submitted: 2023-12-22
• Study First Submitted QC: 2023-12-22
• Last Update Submitted: 2023-12-22
• Study First Posted: 2024-01-08
• Last Update Posted: 2024-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SBRT+PD-1 blockers	Stereotactic body radiotherapy (SBRT)	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	PD-1 blocking antibody	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 Outcome Measures

Name	Time	Method
progression-free survival (PFS)	12 months	PFS was defined as the time from SBRT to disease progression

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	18 months	OS was defined as the time from SBRT to death from any cause.
Adverse Events (AEs)	18 months	All kinds of side effects.
local progression-free survival (LPFS)	12 months	LPFS was defined as the time from SBRT to local progression.
Pain relief rate (PRR）	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.

Trial Locations

Locations (1)

Junjie Wang; 🇨🇳 Beijing, Beijing, China