A Phase 2 interventional study of SBRT + Ipilimumab N01 + Sintilimab + AG Chemotherapy in Pancreatic Cancer, sponsored by Shandong Cancer Hospital and Institute. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Shandong Cancer Hospital and Institute · Phase 2, Interventional, and Treatment
Among 629 studies in Pancreatic Neoplasms with a site in China — 335 open to participants now, 359 under way, 30 of them phase 3. Pancreatic Neoplasms · China.
Among the 629 studies in Pancreatic Neoplasms with a site in China, this one is the 298th largest by planned enrollment of the 507 interventional ones that give a count, is one of 57 that started in 2026, is one of 154 in phase 2, reaches primary completion later than 344 of the 358 other live ones, and was the 604th registered.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.
Browse Pancreatic Neoplasms studies →335 of the 629 studies in Pancreatic Neoplasms with a site in China are open now. Recruiting first, the newest first:
Jiangsu HengRui Medicine Co., Ltd. · Sites in China
Ages 18–70
Ningbo Medical Center Lihuili Hospital · Sites in China
Ages 18–85
West China Hospital · Sites in China
Ages 18–75
Genfleet Therapeutics (Shanghai) Inc. · Sites in China
Ages 18–80
Peking University Third Hospital · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 746 Pancreatic Neoplasms studies recruiting now, 479 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
629 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 190 · Phase 2 246 · Phase 3 54 · Phase 4 8
First in 2001; this study’s year is marked. 57 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 47 is close to the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.
Median enrollment 58 across the 507 interventional studies, 220 across the 121 observational. Of the 112 that completed or were terminated, 12 (11%) have results posted.
This tab as a report to print or save as PDF → With an account.
135 of 629 have an industry lead sponsor. The 10 most frequent:
Shandong Cancer Hospital and Institute is the lead sponsor of 105 studies on the registry; 38 are open to participants now.
Shandong Cancer Hospital and Institute has 6 studies filed under Pancreatic Neoplasms — fewer than ten, so there is no comparison to draw.
101 of the studies in Pancreatic Neoplasms with a site in China that are under way reach primary completion within a year, 10 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06601283Phase 3Fudan UniversityVitamin C Plus Cordyceps to Chemotherapy Related Anemia in Pancreatic Cancer | 2026-11-22 |
| NCT05653453Phase 3Jiangsu Healthy Life Innovation Medical Technology Co., LtdClinical Study of Tumor Treating Fields Combined with Gemcitabine and Albumin-bound Paclitaxel in the First-line Treatment of Locally Advanced Pancreatic Cancer | 2026-12-25 |
| NCT06217042Phase 3Fudan UniversityHR070803 in Combination With Oxaliplatin, 5-fluorouracil/LV Versus GX as Adjuvant Therapy for Pancreatic Cancer | 2027-03-30 |
| NCT06953999Phase 3AkesoA Phase III Study of Ivonescimab + Chemo With/Without AK117 in Metastatic Pancreatic Cancer | 2027-05-14 |
| NCT06409429Phase 3Tianjin Medical University Cancer Institute and HospitalNimotuzumab Combined With GX as Postoperative Adjuvant Therapy in Pancreatic Cancer | 2027-05-30 |
Among the 629 studies in Pancreatic Neoplasms with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: SBRT + Ipilimumab N01 + Sintilimab + AG Chemotherapy
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.
This study also gives Ipilimumab. No intervention listed here names it: that was found by reading the record.
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.
Time frame: From initiation of study treatment until disease progression or death, assessed up to 36 months
Overall Survival (OS)
Overall survival is defined as the time from initiation of study treatment to death from any cause.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From initiation of study treatment until 30 days after the last dose of study treatment
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Jul 2029, 35 months after the start.
Of 324 non-industry phase 2 interventional studies under Pancreatic Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 80. This study's planned 35 months is below that.
Counting every sponsor, half of 393 studies reached it within 57 months; a quarter within 35 and three quarters within 80.
Start moved once since we started tracking on Sep 25, 2026: Jul 2026 → Aug 2026, on Oct 13, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Ipilimumab
Shandong Cancer Hospital and Institute →