Stereotactic Body RadiotherapyNCT06195254
Stereotactic Body Radiotherapy Combined With PD-1 Blockers for Locally Advanced or Locally Recurrent Pancreatic Cancer
An observational study of Stereotactic Body Radiotherapy and PD-1 Inhibitors, run by Peking University Third Hospital at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stereotactic Body Radiotherapy, PD-1 Inhibitors, Pancreatic Cancer
- What is being tested?
- Stereotactic body radiotherapy (SBRT) and PD-1 blocking antibody
- Type of treatment
- Surgery or procedure
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 15 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Clinical Study of Stereotactic Body Radiotherapy Combined With PD-1 Blockers for Locally Advanced or Locally Recurrent Pancreatic Carcinoma.
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.
Read the 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.
- Being tested
- Stereotactic body radiotherapy (SBRT), PD-1 blocking antibody
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Stereotactic body radiotherapy (SBRT); Drug: PD-1 blocking antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
PFS was defined as the time from SBRT to disease progression
Measured: 12 months
Secondary outcomes (4)
local progression-free survival (LPFS)
LPFS was defined as the time from SBRT to local progression.
Measured: 12 months
Overall survival (OS)
OS was defined as the time from SBRT to death from any cause.
Measured: 18 months
Adverse Events (AEs)
All kinds of side effects.
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Dec 2020
- Primary completion21 May 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stereotactic Body RadiotherapyStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junjie Wang, M.D., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195254
- Sponsor's protocol ID
- preSPARK-1
- Status last verified
- Dec 2020
- First submitted
- 22 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Clinical Study of Stereotactic Body Radiotherapy Combined With PD-1 Blockers for Locally Advanced or Locally Recurrent Pancreatic Carcinoma.
- ClinicalTrials.gov ID
- NCT06195254
- Acronym / sponsor ID
- preSPARK-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 21 May 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT+PD-1 blockers | – | Radiation: Stereotactic body radiotherapy (SBRT), Drug: PD-1 blocking antibodypembrolizumab (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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic body radiotherapy (SBRT)All the patients first received SBRT with the dose of 25Gy up to 50Gy in five fractions. | Radiation | SBRT+PD-1 blockers |
| PD-1 blocking antibodyAll 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. | Drug | SBRT+PD-1 blockers |
Primary outcome
progression-free survival (PFS)
Time frame: 12 months
PFS was defined as the time from SBRT to disease progression
4 secondary outcomes
local progression-free survival (LPFS)
Time frame: 12 months
Overall survival (OS)
Time frame: 18 months
Adverse Events (AEs)
Time frame: 18 months
Pain relief rate (PRR）
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Individual participant dataSharing planned: Yes. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junjie Wang, M.D. principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stereotactic Body Radiotherapy and PD-1 Inhibitors, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (PFS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.