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

June 28, 2026 updated by: Jinbo Yue, Shandong Cancer Hospital and Institute

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

47

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 0531
        • Shandong Cancer Hospital And Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From initiation of study treatment until disease progression or death, assessed up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From initiation of study treatment until death from any cause, assessed up to 36 months
Overall survival is defined as the time from initiation of study treatment to death from any cause.
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
Disease control rate is defined as the proportion of participants who achieve complete response, partial response, or stable disease according to RECIST 1.1.
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
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.
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
Objective response rate is defined as the proportion of participants who achieve complete response or partial response according to RECIST 1.1.
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
Safety will be assessed by the incidence and severity of adverse events and serious adverse events, graded according to applicable safety criteria.
From initiation of study treatment until 30 days after the last dose of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Cancer Hospital and Institute

Investigators

  • Principal Investigator: Jinbo Yue, Doctor, Shandong Cancer Hospital And Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 15, 2026

Primary Completion (Estimated)

July 15, 2029

Study Completion (Estimated)

July 15, 2029

Study Registration Dates

First Submitted

June 24, 2026

First Submitted That Met QC Criteria

June 28, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

June 28, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDZLEC2026-050-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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