Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT + Ipilimumab N01 + Sintilimab + AG Chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT + Ipilimumab N01 + Sintilimab + AG Chemotherapy
- description
- 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.
- interventionNames
- Drug: SBRT + Ipilimumab N01 + Sintilimab + AG Chemotherapy
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- From initiation of study treatment until disease progression or death, assessed up to 36 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available