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

NCT07683221 | Not Yet Recruiting Phase 2

• 1 other identifier: SDZLEC2026-050-002
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pancreatic Cancer

Keywords

SBRT; Ipilimumab; Sintilimab; Locally Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  From initiation of study treatment until disease progression or death, assessed up to 36 months

Secondary Outcomes (5)

• Overall Survival (OS)

  From initiation of study treatment until death from any cause, assessed up to 36 months

• Disease Control Rate (DCR)

  From initiation of study treatment until disease progression or death, assessed up to 36 months

• Duration of Response (DoR)

  From first documented response until disease progression or death, assessed up to 36 months

• Objective Response Rate (ORR)

  From initiation of study treatment until disease progression or death, assessed up to 36 months

• Incidence and Severity of Adverse Events

  From initiation of study treatment until 30 days after the last dose of study treatment

Study Arms (1)

SBRT + Ipilimumab N01 + Sintilimab + AG Chemotherapy

EXPERIMENTAL

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

Interventions

SBRT + Ipilimumab N01 + Sintilimab + AG Chemotherapy DRUG

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.

SBRT + Ipilimumab N01 + Sintilimab + AG Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, 0531, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiosurgery; sintilimab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jinbo Yue, Doctor

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinbo Yue, Doctor

CONTACT

0531-67626442; jbyue@sdfmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Radiation Oncology Department

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 6, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): July 15, 2029
• Study Completion (Estimated): July 15, 2029
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)