SBRT Followed by Ipilimumab N01, Sintilimab, Nab-Paclitaxel and Gemcitabine for Locally Advanced Pancreatic Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShandong Cancer Hospital and Institute

About this 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • SBRT + Ipilimumab N01 + Sintilimab + AG Chemotherapy

Treatment groups

47 Participants
are divided into 1 treatment group