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.
Age ≥ 18 years and ≤ 75 years, ECOG score of ≤2 points, expected survival time ≥ 3 months.
Patients with histologically or cytologically confirmed advanced metastatic pancreatic cancer.
Imaging suggests distant measurable lesions.
Failure of first-line therapy and no use of fluorouracil, irinotecan, or liposomal irinotecan drugs in the first-line therapy.
Have received second-line or more anti-tumor therapy in the past.
First-line treatment with fluorouracil, irinotecan or liposomal irinotecan, etc.
Patient has a prior history of other tumors, unless it is cervical cancer in situ, treated squamous cell carcinoma or bladder epithelial tumors (Ta and TIS) or other malignancies that have received curative therapy (at least more than 5 years prior to enrollment).
Patient has an active bacterial or fungal infection (≥ 3rd edition NCI-CTC2 grade).
Single group
nal-IRI,5-fu,LV, benmelstobart, anlotinib
Drugliposomal irinotecan (nal-IRI) plus 5-fluorouracil (5-FU)/leucovorin (LV) (nal-IRI/5-FU/LV) combined with benmelstobart and anlotinib ± SBRT
Objective effective rate (ORR)
The overall response rate, including complete response (CR) + partial response (PR), refers to the proportion of patients whose tumor shrinks to a certain amount and remains for a certain period of time.
Disease control rate (DCR)
Refers to the proportion of patients whose tumors have shrunk or stable and remain for a certain period of time, including complete remission (CR), partial remission (PR) and stable (SD) cases.
Median overall survival (mOS)
Refers to the numerical value in which the survival time of all patients is arranged in the order from smallest to largest in clinical research, and is located in the middle position.
Median progression-free survival (mPFS)
Refers to the value in which all patients are sorted according to the length of progression-free survival time in clinical studies, and is located in the middle position.
Exploring potential efficacy prediction biomarkers
Explore potential efficacy prediction biomarkers: including patients\' tumor-related serological indicators, such as peripheral blood lymphocyte count, twelve cytokine tests (IL-2, IFN-γ, TNF-α, IL-4, IL-5, IL6, IL-10, IL-17, IL-1β, IL-8, IFN-α, IL-12p70) and ctDNA detection. This type of index was collected once at the baseline of the patient, and again after every 2 cycles of treatment until the patient entered the maintenance phase or the disease progressed.
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