Locally Advanced Pancreatic CancerPhase 2NCT06009029
SBRT Combined With Zimberelimab (GLS-010) in Locally Advanced Pancreatic Cancer (SPARK-1 Study)
A Phase 2 study testing Stereotactic body radiation(SBRT) and Zimberelimab (GLS-010) in people with Locally Advanced Pancreatic Cancer, run by Peking University Third Hospital.
Trial summary
This trial is designed to investigate the efficacy and safety of patients with locally advanced pancreatic cancer by SBRT combined with Zimberelimab(GLS-010). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Pancreatic Cancer
- What is being tested?
- Stereotactic body radiation(SBRT) and Zimberelimab (GLS-010)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old.
- Locally advanced pancreatic cancer confirmed histologically and defined according to the NCCN Pancreatic Cancer Guidelines v1.2022 as unresectable or surgically declined.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- The expected survival ≥ 3 months.
- At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.
- Patient must have adequate organ function defined by the study-specified laboratory tests.
Who cannot join
- Tumor invasion of the gastrointestinal tract, specifically pancreatic tumor or lymph node metastasis invading the gastrointestinal parenchyma.
- Woman who are pregnant or breastfeeding.
- Has a known additional malignancy within the past 5 years, except for cured skin cancer and cervical carcinoma in situ.
- Patients who have received prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.
- Contraindications to immunotherapy.
- Other conditions that investigator decides not suitable for the trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Single-arm, Prospective Study of SBRT Combined With Zimberelimab (GLS-010) in Patients With Locally Advanced Pancreatic Cancer (SPARK-1 Study)
This trial is designed to investigate the efficacy and safety of patients with locally advanced pancreatic cancer by SBRT combined with Zimberelimab(GLS-010).
Read the detailed description
This a prospective, single-arm, multicenter study evaluating the efficacy and safety of stereotactic radiotherapy (SBRT) and Zimberelimab(GLS-010) in patients with pancreatic cancer. The primary endpoint is OS, and the secondary are PFS, ORR,DCR and adverse events.
- Conditions
- Locally Advanced Pancreatic Cancer
- Being tested
- Stereotactic body radiation(SBRT), Zimberelimab (GLS-010)
- Keywords
- Locally Advanced Pancreatic Cancer, SBRT, Zimberelimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiation(SBRT)Radiation
SBRT: 7-10 Gy/F, 5 doses
Zimberelimab: 240mg d1 iv Q21D, within 7 days after SBRT completion. Receiving a minimum of six cycles of treatment, or disease progression or intolerable toxic side effects.
Zimberelimab (GLS-010)Drug
Also called Immunotherapy
Zimberelimab (GLS-010),240mg d1 iv Q21D
| Study group | Role | What they receive |
|---|---|---|
| SBRT Combined With Zimberelimab | Experimental | Patients diagnosed with locally advanced pancreatic cancer are treated with SBRT combined with Zimberelimab Receives: Radiation: Stereotactic body radiation(SBRT); Drug: Zimberelimab (GLS-010) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Overall survival (PFS) will be defined as the elapsed time from the first date of study treatment until death from any cause. For patients who remain alive, follow-up time will be censored at the date of last disease assessment.
Measured: 2 years
Secondary outcomes (4)
Progression-free survival (PFS)
Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per RECIST 1.1) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment.
Measured: 2 years
Objective response rate (ORR)
Disease control rate will be defined as PR +CR rate.
Measured: 2 years
Disease Control Rate (DCR)
Disease control rate will be defined as objective response rate + steady disease rate.
Measured: 2 years
Adverse Events
Based on NCI-CTC AE v5.0
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Pancreatic CancerStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
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
- NCT06009029
- Sponsor's protocol ID
- SPARK-1
- Status last verified
- Jul 2023
- First submitted
- 9 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-arm, Prospective Study of SBRT Combined With Zimberelimab (GLS-010) in Patients With Locally Advanced Pancreatic Cancer (SPARK-1 Study)
- ClinicalTrials.gov ID
- NCT06009029
- Acronym / sponsor ID
- SPARK-1
- Conditions
- Locally Advanced Pancreatic Cancer
- Keywords
- Locally Advanced Pancreatic Cancer, SBRT, Zimberelimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 24 Aug 2023 (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.
This trial is designed to investigate the efficacy and safety of patients with locally advanced pancreatic cancer by SBRT combined with Zimberelimab(GLS-010).
Detailed description
This a prospective, single-arm, multicenter study evaluating the efficacy and safety of stereotactic radiotherapy (SBRT) and Zimberelimab(GLS-010) in patients with pancreatic cancer. The primary endpoint is OS, and the secondary are PFS, ORR,DCR and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT Combined With Zimberelimab | Experimental | Radiation: Stereotactic body radiation(SBRT), Drug: Zimberelimab (GLS-010)Patients diagnosed with locally advanced pancreatic cancer are treated with SBRT combined with Zimberelimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-75 years old.
- Locally advanced pancreatic cancer confirmed histologically and defined according to the NCCN Pancreatic Cancer Guidelines v1.2022 as unresectable or surgically declined.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- The expected survival ≥ 3 months.
- At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.
Key exclusion criteria (6 listed)
- Tumor invasion of the gastrointestinal tract, specifically pancreatic tumor or lymph node metastasis invading the gastrointestinal parenchyma.
- Woman who are pregnant or breastfeeding.
- Has a known additional malignancy within the past 5 years, except for cured skin cancer and cervical carcinoma in situ.
- Patients who have received prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.
- Contraindications to immunotherapy.
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 radiation(SBRT)SBRT: 7-10 Gy/F, 5 doses Zimberelimab: 240mg d1 iv Q21D, within 7 days after SBRT completion. Receiving a minimum of six cycles of treatment, or disease progression or intolerable toxic side effects. | Radiation | SBRT Combined With Zimberelimab |
| Zimberelimab (GLS-010)Also: ImmunotherapyZimberelimab (GLS-010),240mg d1 iv Q21D | Drug | SBRT Combined With Zimberelimab |
Primary outcome
Overall survival (OS)
Time frame: 2 years
Overall survival (PFS) will be defined as the elapsed time from the first date of study treatment until death from any cause. For patients who remain alive, follow-up time will be censored at the date of last disease assessment.
4 secondary outcomes
Progression-free survival (PFS)
Time frame: 2 years
Objective response rate (ORR)
Time frame: 2 years
Disease Control Rate (DCR)
Time frame: 2 years
Adverse Events
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Junjie Wang, M.D. principal investigator
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic body radiation(SBRT) and Zimberelimab (GLS-010) in people with Locally Advanced Pancreatic Cancer, run by Peking University Third Hospital.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junjie Wang, M.D. (+8613701076310, wangjunjie_puth@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: 2 years). 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 24 Aug 2023.