Pancreatic Cancer
Conditions
Keywords
SBRT, Ipilimumab, Sintilimab, Locally Advanced Pancreatic Cancer
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.
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.
Interventions
DRUGSBRT + 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.
Sponsors
Shandong Cancer Hospital and Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 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. |
| Disease Control Rate (DCR) | 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. |
| Duration of Response (DoR) | 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. |
| Objective Response Rate (ORR) | 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. |
| Incidence and Severity of Adverse Events | 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. |
Countries
China
Contacts
CONTACTJinbo Yue, Doctor
PRINCIPAL_INVESTIGATORJinbo Yue, Doctor
Shandong Cancer Hospital and Institute
Outcome results
None listed