Actively Recruiting
Nal-IRI/5-FU/LV Chemotherapy Combined With PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT as Second-line Therapy in Metastatic Pancreatic Cancer Patients
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2026-02-06
56
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-arm, multi-center, multi-cohort, prospective clinical study initiated by the investigator. The indication of this study is: patients with advanced metastatic pancreatic cancer who have progressed after first-line chemotherapy. Eligible patients will be assigned to liposomal irinotecan (nal-IRI) plus 5-fluorouracil (5-FU)/leucovorin (LV) (nal-IRI/5-FU/LV) combined with benmelstobart and anlotinib ± SBRT. The total sample size for this study is expected to be 56 subjects.
CONDITIONS
Official Title
Nal-IRI/5-FU/LV Chemotherapy Combined With PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT as Second-line Therapy in Metastatic Pancreatic Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years with an ECOG score of 2 or less and expected survival of at least 3 months
- Histologically or cytologically confirmed advanced metastatic pancreatic cancer
- Imaging shows distant measurable lesions
- Failure of first-line therapy without prior use of fluorouracil, irinotecan, or liposomal irinotecan
- Neutrophil count of at least 1.5 x 10^9/L
- Hemoglobin level of at least 10 g/dL
- Platelet count of at least 100 x 10^9/L
- Total bilirubin less than or equal to 1.5 times the upper limit of normal
- AST and ALT less than 1.5 times the upper limit of normal
- Creatinine clearance of at least 60 ml/min
- Women of childbearing potential must use effective contraception before and during the study
- Signed informed consent form
- Ability to follow the study protocol and attend follow-up visits
You will not qualify if you...
- Prior treatment with second-line or later anti-tumor therapies
- First-line treatment included fluorouracil, irinotecan, or liposomal irinotecan
- History of other tumors except certain curatively treated cancers over 5 years ago
- Active bacterial or fungal infection of grade 2 or higher
- Infection with HIV, HCV, or HBV
- Uncontrolled coronary artery disease, asthma, cerebrovascular disease, or other conditions deemed unsuitable
- Autoimmune diseases or immunodeficiency requiring immunosuppressive drugs
- Pregnant or lactating women
- Substance abuse or psychological/social factors affecting consent or study participation
- Allergy to any of the treatment drugs
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 025
Actively Recruiting
Research Team
J
Juan Du, M.D. Ph.D
CONTACT
D
DU
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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