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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06195254
• Other study ID #: preSPARK-1
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: December 15, 2023

Study information

• Verified date: December 2020
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 15, 2023
• Est. primary completion date: May 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms
• PD-1 Inhibitors
• Stereotactic Body Radiotherapy

Intervention

Radiation:
• Stereotactic body radiotherapy (SBRT)
All the patients first received SBRT with the dose of 25Gy up to 50Gy in five fractions.

Drug:
• 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.

Locations

Country	Name	City	State
China	Junjie Wang	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival (PFS)	PFS was defined as the time from SBRT to disease progression	12 months
Secondary	local progression-free survival (LPFS)	LPFS was defined as the time from SBRT to local progression.	12 months
Secondary	Overall survival (OS)	OS was defined as the time from SBRT to death from any cause.	18 months
Secondary	Adverse Events (AEs)	All kinds of side effects.	18 months
Secondary	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.	18 months