Pancreatic CancerPhase 2NCT07683221
SBRT Followed by Ipilimumab N01, Sintilimab, Nab-Paclitaxel and Gemcitabine for Locally Advanced Pancreatic Cancer
A Phase 2 study testing SBRT + Ipilimumab N01 + Sintilimab + AG Chemotherapy in people with Pancreatic Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial summary
This is a Phase II, prospective, single-arm exploratory clinical trial designed to evaluate the efficacy and safety of stereotactic body radiotherapy followed by ipilimumab N01 plus sintilimab in combination with nab-paclitaxel and gemcitabine in patients with locally advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- SBRT + Ipilimumab N01 + Sintilimab + AG Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2026to 15 Jul 2029
- 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
- Participants voluntarily agree to participate in the study, sign the informed consent form, and are willing and able to comply with study procedures and follow-up.
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma.
- Locally advanced unresectable pancreatic cancer without distant metastasis, confirmed by multidisciplinary team evaluation.
- Age 18 to 75 years, inclusive.
- Eastern Cooperative Oncology Group performance status of 0 to 1.
- Life expectancy of at least 3 months.
- No prior systemic therapy for advanced pancreatic cancer.
- At least one measurable lesion according to RECIST 1.1.
Who cannot join
- Participation in another anti-cancer drug clinical trial within 4 weeks before enrollment.
- Prior targeted therapy or prior treatment with immune checkpoint inhibitors.
- Presence of distant organ metastasis, including liver, peritoneal, brain, or meningeal metastasis.
- Pregnancy or breastfeeding.
- Any condition that, in the investigator's opinion, makes the participant unsuitable for enrollment in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong Cancer Hospital and Institute
Jinan, Shandong, 0531
Jinbo Yue Doctor, Doctor, 0531-67626442, jbyue@sdfmu.edu.cn
Jinbo Yue Doctor, Doctor, jbyue@sdfmu.edu.cn
About this study
Official title: Stereotactic Body Radiotherapy Followed by Ipilimumab N01 Plus Sintilimab in Combination With Nab-Paclitaxel and Gemcitabine for the Treatment of Locally Advanced Pancreatic Cancer: A Phase II, Prospective, Single-Arm Exploratory Clinical Trial
This is a Phase II, prospective, single-arm exploratory clinical trial designed to evaluate the efficacy and safety of stereotactic body radiotherapy followed by ipilimumab N01 plus sintilimab in combination with nab-paclitaxel and gemcitabine in patients with locally advanced pancreatic cancer. Eligible patients will receive SBRT followed by sequential systemic therapy. The primary endpoint is progression-free survival, and secondary endpoints include overall survival, disease control rate, duration of response, objective response rate, and safety.
Read the detailed description
This study is a Phase II, prospective, single-arm exploratory clinical trial in patients with locally advanced pancreatic cancer. The study aims to explore the efficacy and safety of stereotactic body radiotherapy followed by ipilimumab N01 plus sintilimab in combination with nab-paclitaxel and gemcitabine.
Eligible patients will first receive stereotactic body radiotherapy at a dose of 5-10 Gy for 5 fractions. One week after completion of SBRT, patients will receive sequential systemic therapy consisting of ipilimumab N01, sintilimab, nab-paclitaxel, and gemcitabine. Ipilimumab N01 will be administered at 1 mg/kg intravenously every 6 weeks for a total of 4 doses. Sintilimab will be administered at 200 mg intravenously every 3 weeks. Nab-paclitaxel will be administered at 125 mg/m² on Days 1 and 8, and gemcitabine will be administered at 1000 mg/m² on Days 1 and 8 of each 3-week cycle. Nab-paclitaxel and gemcitabine will be given for 6 to 8 cycles, and sintilimab may be continued as maintenance treatment until disease progression, unacceptable toxicity, withdrawal of consent, initiation of new anti-cancer therapy, death, or other protocol-specified reasons.
Tumor assessments will be performed regularly according to RECIST 1.1. The primary endpoint is progression-free survival. Secondary endpoints include overall survival, disease control rate, duration of response, objective response rate, and safety. Adverse events will be monitored throughout the study and graded according to applicable safety criteria.
- Conditions
- Pancreatic Cancer
- Being tested
- SBRT + Ipilimumab N01 + Sintilimab + AG Chemotherapy
- Keywords
- SBRT, Ipilimumab, Sintilimab, Locally Advanced Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRT + Ipilimumab N01 + Sintilimab + AG ChemotherapyDrug
Participants will receive stereotactic body radiotherapy at 5-10 Gy in 5 fractions, followed one week later by sequential systemic therapy with ipilimumab N01, sintilimab, nab-paclitaxel, and gemcitabine. Ipilimumab N01 will be administered at 1 mg/kg intravenously every 6 weeks for a total of 4 doses. Sintilimab will be administered at 200 mg intravenously every 3 weeks. Nab-paclitaxel 125 mg/m² and gemcitabine 1000 mg/m² will be administered on Days 1 and 8 of each 3-week cycle. AG chemotherapy will be given for 6 to 8 cycles, and sintilimab may continue as maintenance therapy until disease progression or other protocol-specified discontinuation criteria.
| Study group | Role | What they receive |
|---|---|---|
| SBRT + Ipilimumab N01 + Sintilimab + AG Chemotherapy | Experimental | Participants will receive stereotactic body radiotherapy at 5-10 Gy in 5 fractions, followed one week later by sequential systemic therapy with ipilimumab N01, sintilimab, nab-paclitaxel, and gemcitabine. Ipilimumab N01 will be administered at 1 mg/kg intravenously every 6 weeks for a total of 4 doses. Sintilimab will be administered at 200 mg intravenously every 3 weeks. Nab-paclitaxel 125 mg/m² and gemcitabine 1000 mg/m² will be administered on Days 1 and 8 of each 3-week cycle. AG chemotherapy will be given for 6 to 8 cycles, and sintilimab may continue as maintenance therapy until disease progression or other protocol-specified discontinuation criteria. Receives: Drug: SBRT + Ipilimumab N01 + Sintilimab + AG Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from the initiation of study treatment to the first documented disease progression according to RECIST 1.1 or death from any cause, whichever occurs first.
Measured: From initiation of study treatment until disease progression or death, assessed up to 36 months
Secondary outcomes (5)
Overall Survival (OS)
Overall survival is defined as the time from initiation of study treatment to death from any cause.
Measured: From initiation of study treatment until death from any cause, assessed up to 36 months
Disease Control Rate (DCR)
Disease control rate is defined as the proportion of participants who achieve complete response, partial response, or stable disease according to RECIST 1.1.
Measured: From initiation of study treatment until disease progression or death, assessed up to 36 months
Duration of Response (DoR)
Duration of response is defined as the time from the first documented complete response or partial response to disease progression or death from any cause, whichever occurs first.
Measured: From first documented response until disease progression or death, assessed up to 36 months
Objective Response Rate (ORR)
Objective response rate is defined as the proportion of participants who achieve complete response or partial response according to RECIST 1.1.
Measured: From initiation of study treatment until disease progression or death, assessed up to 36 months
Incidence and Severity of Adverse Events
Safety will be assessed by the incidence and severity of adverse events and serious adverse events, graded according to applicable safety criteria.
Measured: From initiation of study treatment until 30 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start5 Aug 2026
- Primary completion15 Jul 2029 (estimated)
- Study completion15 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinbo Yue, Shandong Cancer Hospital and Institute
- Investigators
- Jinbo Yue, Doctor, Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683221
- Sponsor's protocol ID
- SDZLEC2026-050-002
- Status last verified
- Oct 2026
- First submitted
- 24 Jun 2026
- Last updated
- 13 Oct 2026
- 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiotherapy Followed by Ipilimumab N01 Plus Sintilimab in Combination With Nab-Paclitaxel and Gemcitabine for the Treatment of Locally Advanced Pancreatic Cancer: A Phase II, Prospective, Single-Arm Exploratory Clinical Trial
- ClinicalTrials.gov ID
- NCT07683221
- Acronym / sponsor ID
- SDZLEC2026-050-002
- Conditions
- Pancreatic Cancer
- Keywords
- SBRT, Ipilimumab, Sintilimab, Locally Advanced Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- 15 Jul 2029 (estimated)
- Study completion
- 15 Jul 2029 (estimated)
- First posted
- 6 Jul 2026 (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 is a Phase II, prospective, single-arm exploratory clinical trial designed to evaluate the efficacy and safety of stereotactic body radiotherapy followed by ipilimumab N01 plus sintilimab in combination with nab-paclitaxel and gemcitabine in patients with locally advanced pancreatic cancer. Eligible patients will receive SBRT followed by sequential systemic therapy. The primary endpoint is progression-free survival, and secondary endpoints include overall survival, disease control rate, duration of response, objective response rate, and safety.
Detailed description
This study is a Phase II, prospective, single-arm exploratory clinical trial in patients with locally advanced pancreatic cancer. The study aims to explore the efficacy and safety of stereotactic body radiotherapy followed by ipilimumab N01 plus sintilimab in combination with nab-paclitaxel and gemcitabine.
Eligible patients will first receive stereotactic body radiotherapy at a dose of 5-10 Gy for 5 fractions. One week after completion of SBRT, patients will receive sequential systemic therapy consisting of ipilimumab N01, sintilimab, nab-paclitaxel, and gemcitabine. Ipilimumab N01 will be administered at 1 mg/kg intravenously every 6 weeks for a total of 4 doses. Sintilimab will be administered at 200 mg intravenously every 3 weeks. Nab-paclitaxel will be administered at 125 mg/m² on Days 1 and 8, and gemcitabine will be administered at 1000 mg/m² on Days 1 and 8 of each 3-week cycle. Nab-paclitaxel and gemcitabine will be given for 6 to 8 cycles, and sintilimab may be continued as maintenance treatment until disease progression, unacceptable toxicity, withdrawal of consent, initiation of new anti-cancer therapy, death, or other protocol-specified reasons.
Tumor assessments will be performed regularly according to RECIST 1.1. The primary endpoint is progression-free survival. Secondary endpoints include overall survival, disease control rate, duration of response, objective response rate, and safety. Adverse events will be monitored throughout the study and graded according to applicable safety criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT + Ipilimumab N01 + Sintilimab + AG Chemotherapy | Experimental | Drug: SBRT + Ipilimumab N01 + Sintilimab + AG ChemotherapyParticipants will receive stereotactic body radiotherapy at 5-10 Gy in 5 fractions, followed one week later by sequential systemic therapy with ipilimumab N01, sintilimab, nab-paclitaxel, and gemcitabine. Ipilimumab N01 will be administered at 1 mg/kg intravenously every 6 weeks for a total of 4 doses. Sintilimab will be administered at 200 mg intravenously every 3 weeks. Nab-paclitaxel 125 mg/m² and gemcitabine 1000 mg/m² will be administered on Days 1 and 8 of each 3-week cycle. AG chemotherapy will be given for 6 to 8 cycles, and sintilimab may continue as maintenance therapy until disease progression or other protocol-specified discontinuation criteria. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants voluntarily agree to participate in the study, sign the informed consent form, and are willing and able to comply with study procedures and follow-up.
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma.
- Locally advanced unresectable pancreatic cancer without distant metastasis, confirmed by multidisciplinary team evaluation.
- Age 18 to 75 years, inclusive.
- Eastern Cooperative Oncology Group performance status of 0 to 1.
Key exclusion criteria (5 listed)
- Participation in another anti-cancer drug clinical trial within 4 weeks before enrollment.
- Prior targeted therapy or prior treatment with immune checkpoint inhibitors.
- Presence of distant organ metastasis, including liver, peritoneal, brain, or meningeal metastasis.
- Pregnancy or breastfeeding.
- Any condition that, in the investigator's opinion, makes the participant unsuitable for enrollment in this study.
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 |
|---|---|---|
| SBRT + Ipilimumab N01 + Sintilimab + AG ChemotherapyParticipants will receive stereotactic body radiotherapy at 5-10 Gy in 5 fractions, followed one week later by sequential systemic therapy with ipilimumab N01, sintilimab, nab-paclitaxel, and gemcitabine. Ipilimumab N01 will be administered at 1 mg/kg intravenously every 6 weeks for a total of 4 doses. Sintilimab will be administered at 200 mg intravenously every 3 weeks. Nab-paclitaxel 125 mg/m² and gemcitabine 1000 mg/m² will be administered on Days 1 and 8 of each 3-week cycle. AG chemotherapy will be given for 6 to 8 cycles, and sintilimab may continue as maintenance therapy until disease progression or other protocol-specified discontinuation criteria. | Drug | SBRT + Ipilimumab N01 + Sintilimab + AG Chemotherapy |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From initiation of study treatment until disease progression or death, assessed up to 36 months
Progression-free survival is defined as the time from the initiation of study treatment to the first documented disease progression according to RECIST 1.1 or death from any cause, whichever occurs first.
5 secondary outcomes
Overall Survival (OS)
Time frame: From initiation of study treatment until death from any cause, assessed up to 36 months
Disease Control Rate (DCR)
Time frame: From initiation of study treatment until disease progression or death, assessed up to 36 months
Duration of Response (DoR)
Time frame: From first documented response until disease progression or death, assessed up to 36 months
Objective Response Rate (ORR)
Time frame: From initiation of study treatment until disease progression or death, assessed up to 36 months
Incidence and Severity of Adverse Events
Time frame: From initiation of study treatment until 30 days after the last dose of study treatment
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 13 Oct 2026.
- 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.
Jinbo Yue, Doctor principal investigator
Shandong Cancer Hospital and Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SBRT + Ipilimumab N01 + Sintilimab + AG Chemotherapy in people with Pancreatic Cancer, run by Shandong Cancer Hospital and Institute 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 8 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. 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.
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 Jinbo Yue, Doctor (0531-67626442, jbyue@sdfmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From initiation of study treatment until disease progression or death, assessed up to 36 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 13 Oct 2026.