Phase
Condition
Digestive System Neoplasms
Treatment
nal-IRI,5-fu,LV, benmelstobart, anlotinib
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years and ≤ 75 years, ECOG score of ≤2 points, expected survival time ≥ 3months.
Patients with histologically or cytologically confirmed advanced metastaticpancreatic cancer.
Imaging suggests distant measurable lesions.
Failure of first-line therapy and no use of fluorouracil, irinotecan, or liposomalirinotecan drugs in the first-line therapy.
Patients need to meet the following hematologic indicators e1. Neutrophil count ≥ 1.5×109/L e2. Hemoglobin ≥ 10 g/dL e3. Platelet count ≥ 100×109/L f. Patients need to meet the following biochemical parameters f1. Total bilirubin ≤ 1.5× upper limit of normal (ULN) f2. AST and ALT <1.5×ULN f3. Creatinine clearance ≥ 60ml/min g. Patients of childbearing age need to take appropriate protective measures (contraception or other methods of birth control) before enrollment and during the trial.
H. Has signed an informed consent form. i. Able to follow the study protocol and follow-up process.
Exclusion
Exclusion Criteria:
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 othermalignancies that have received curative therapy (at least more than 5 years priorto enrollment).
Patient has an active bacterial or fungal infection (≥ 3rd edition NCI-CTC2 grade).
Patient has HIV, HCV, HBV infection, uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease or other disease deemed non-enrollable by the investigator.
f. Patients with autoimmune diseases or immunodeficiencies who should be treated with immunosuppressive drugs.
g. Pregnant and lactating women. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
h. Substance abuse, clinical or psychological, or social factors that compromise informed consent or study conduct.
i. Those who may be allergic to treatment drugs.