NCT07683221RecruitingPhase 2
SBRT Followed by Ipilimumab N01, Sintilimab, Nab-Paclitaxel and Gemcitabine for Locally Advanced Pancreatic Cancer
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 47 (estimated)
- First submitted
- 24 Jun 2026
- Start date
- 5 Aug 2026
- Primary completion date
- 15 Jul 2029
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Diseases
- Pancreatic cancer
- NCT number
- NCT07683221
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 47
- From 5 Aug 2026 to the primary completion date, 15 Jul 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another anti-cancer drug clinical trial within 4 weeks before enrollment.
- Prior targeted therapy or prior treatment with immune checkpoint inhibitors.
Other illness
- Any condition that, in the investigator's opinion, makes the participant unsuitable for enrollment in this study.
Other
- Presence of distant organ metastasis, including liver, peritoneal, brain, or meningeal metastasis.
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shandong Cancer Hospital and Institute Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.