Actively Recruiting
A Phase II Clinical Study of GnP Regimen (Nab-paclitaxel + Gemcitabine) Combined 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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a treatment approach for adults aged 18 to 75 years with locally advanced pancreatic ductal adenocarcinoma, a type of pancreatic cancer confirmed through pathology and imaging studies like CT or MRI. This phase II clinical trial focuses on patients with an ECOG performance status of 0 to 2 and aims to assess the response rate to a combined treatment regimen. Participants receive a combination treatment every 21 days including nab-paclitaxel and gemcitabine on days 1 and 8, along with serplulimab every three weeks. Starting with the second treatment cycle, patients also undergo stereotactic body radiation therapy (SBRT) targeting the main tumor and nearby lymph nodes using specific radiation doses over five sessions. The choice of radiation dose depends on tumor size and nearby organ sensitivity. Patients are regularly evaluated with tumor markers and CT scans every two cycles, and those eligible may have surgery to remove the tumor. Throughout the study, patients undergo comprehensive assessments including imaging and blood tests to monitor treatment effects and eligibility for surgery. The main outcome measured is the investigator-assessed objective response rate over four years. Safety and disease progression are regularly reviewed by a multidisciplinary team. Participation lasts through treatment cycles and possible surgery, with ongoing evaluations to guide care and study outcomes.
CONDITIONS
Brief 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), unresectable per multidisciplinary assessment
- No prior anticancer therapies including chemotherapy, radiotherapy, surgery, or investigational treatments
- Age between 18 and 75 years, any sex
- ECOG performance status of 0 to 2
- Measurable primary tumor lesions meeting size criteria on imaging
- Adequate bone marrow, liver, kidney, coagulation functions, and electrolyte levels
- Corrected QT interval on ECG of 480 ms or less
- 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...
- Allergy or hypersensitivity to study drugs
- Presence of distant metastatic (Stage IV) pancreatic cancer
- Tumors classified as resectable or borderline resectable
- Lesions unsuitable for stereotactic body radiation therapy
- Known or suspected central nervous system metastases unless excluded by imaging
- History of other cancers within 5 years except certain treated skin or cervical cancers
- Need for other anticancer treatments during study period
- Prior or current use of chemotherapy, FAK inhibitors, or immune checkpoint inhibitors
- Immunodeficiency or recent use of immunosuppressive therapy
- Receipt of live vaccines within 30 days before treatment
- Uncontrolled high blood pressure
- Significant recent cardiac disease or arrhythmias
- Recent hemorrhagic or thromboembolic events
- Need for surgery within 28 days before or after study drug administration
- Poorly controlled fluid collections like large pleural effusions or ascites
- History or risk of gastrointestinal perforation
- Use of medications affecting study drug metabolism
- Severe psychiatric disorders
- Pregnancy, potential pregnancy, or breastfeeding
- Unwillingness to use contraception during and three months after study
- Participation in other drug or device trials within 4 weeks prior
- Any other condition considered unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 21-day cycles during treatment period
Participants receive the GnP regimen every 21 days combined with serplulimab every 3 weeks. In the second cycle, participants undergo stereotactic body radiation therapy (SBRT) over 5 sessions every other day targeting the primary tumor and/or retroperitoneal lymph nodes.
1 visit every 21 days for chemotherapy and serplulimab; 5 radiation therapy sessions administered every other day during second cycle
Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
D
Dan Cao, MD
K
Ke Cheng, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here