Actively Recruiting
A Study of GnP RegimenCombined With Serplulimab and Stereotactic Body Radiation Therapy as First-line Treatment for Locally Advanced Pancreatic Cancer
Led by West China Hospital · Updated on 2025-08-07
23
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-arm phase II clinical trial. The study targets patients aged 18-75 years with ECOG performance status 0-2, diagnosed with locally advanced pancreatic ductal adenocarcinoma based on comprehensive assessment of pathology and imaging studies (CT or MRI). Participating patients will receive the GnP regimen every 21 days (nab-paclitaxel 125mg/m² ivgtt on days 1 and 8 + gemcitabine 1000mg/m² ivgtt on days 1 and 8, repeated every 21 days) combined with serplulimab (200mg ivgtt Q3W). In the second cycle, patients will receive SBRT targeting the primary tumor and/or retroperitoneal lymph nodes: 6.6Gy×5 fractions, 7Gy×5 fractions, or 8Gy×5 fractions, administered every other day with radiotherapy completed in 5 sessions (specific selection determined by investigators based on lesion size and organs at risk \[OAR\] assessment). Comprehensive evaluation including tumor markers and CT scans will be performed every 2 cycles with multidisciplinary team (MDT) review, and patients who meet surgical criteria will undergo radical resection surgery.
CONDITIONS
Official Title
A Study of GnP RegimenCombined With Serplulimab and Stereotactic Body Radiation Therapy as First-line Treatment for Locally Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed locally advanced pancreatic ductal adenocarcinoma based on pathology and imaging (CT or MRI), with multidisciplinary team assessment deeming it unresectable
- No prior anticancer treatments including chemotherapy, radiotherapy, surgery, or other investigational therapies
- Age between 18 and 75 years inclusive
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Measurable tumor lesions: primary tumor 10 mm on spiral CT, lymph nodes 15 mm short axis diameter; for conventional CT or physical exam, maximum diameter 20 mm
- Adequate organ function including bone marrow, liver, kidney, coagulation, electrolytes, and heart function as specified
- No history or current autoimmune disease
- Life expectancy of at least 3 months
- Signed informed consent and ability to comply with study requirements
You will not qualify if you...
- Known allergy or hypersensitivity to study drugs
- Presence of distant metastatic (Stage IV) pancreatic cancer
- Tumors deemed resectable or borderline resectable by surgical or multidisciplinary team
- Tumors unsuitable for stereotactic body radiation therapy (SBRT)
- Known or suspected central nervous system metastases unless excluded by imaging
- History of other cancers within 5 years except certain skin and cervical cancers
- Need for other anticancer treatments during study
- Prior use of chemotherapy, FAK inhibitors, or immune checkpoint inhibitors
- Immunodeficiency or recent use of high-dose corticosteroids or immunosuppressive therapy
- Receipt of live vaccines within 30 days prior to treatment
- Uncontrolled high blood pressure
- Significant cardiac diseases or arrhythmias requiring treatment
- History of bleeding or clotting events within 6 months
- Need for surgery within 28 days before or after study treatment
- Poorly controlled fluid collections such as large pleural effusions or ascites
- History or risk of gastrointestinal perforation
- Use of medications affecting study drug metabolism without proper assessment
- Severe psychiatric disorders
- Pregnancy, lactation, or unwillingness to use contraception if of childbearing potential
- Participation in other clinical trials within 4 weeks prior to study
- Any other conditions deemed unsuitable by the investigator
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Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
D
Dan Cao, MD
CONTACT
K
Ke Cheng, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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