Phase
Condition
Digestive System Neoplasms
Treatment
Adebrelimab
Irinotecan liposome
Fluorouracil
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients voluntarily join this study and sign the informed consent form
Age: 18-75 years old (inclusive), male or female
Histologically confirmed pancreatic cancer liver metastases and no previoustreatment of any systemic anti-swelling tumor treatment
No central nervous system metastases
No adjuvant therapy within 6 months prior to enrollment
ECOG PS: 0~1 points
Estimated survival ≥ 12 weeks
Normal function of major organs, meeting the following requirements (7 prior toinitiation of study treatment days): (1) Routine blood examination: (No bloodtransfusion and no use of granules within 14 days before screening.) Cellcolony-stimulating factor [G-CSF], not corrected with medication):1) Hemoglobin [HB]≥90g/L; 2) Absolute neutrophil count [ANC] ≥1.5×10 9 /L; 3) Platelets [PLT] ≥80×10 9 /L; (2) Blood biochemistry tests must meet the following criteria (notransfusion in the 14 days before screening Protein): 1) Serum total bilirubin [TBIL] ≤ 1.5 times the upper limit of normal (ULN); 2) Alanine aminotransferase [ALT], aspartate aminotransferase [AST]<2.5×ULN ; If there is liver metastasis, ALTand AST≤5×ULN; 3) Blood creatinine [Cr]≤1×ULN or endogenous creatinine clearancerate > 50ml/min (Cockcroft-Gault formula); (3) International normalized ratio [INR] ≤ 2.3 or prothrombin time [PT] exceeding Over the range of normal controls≤6seconds: (4) Urine protein < 2+ (if urine protein ≥ 2+, you can urinate eggs for 24hours White quantitative, 24-hour urine protein quantification <1.0g can beenrolled);
Women of childbearing potential must have a pregnancy test (serum or urine) within 7days prior to enrollment The result is negative and voluntarily during theobservation period and after the last dose of study drug8 Use of appropriate methodsof contraception within a week; For males, it should be surgically sterile, orAgrees to adopt appropriate during the observation period and for 8 weeks after thelast dose of study drug method contraception
Those who are expected to have good compliance can follow up the efficacy andadverse reactions according to the requirements of the protocol.
Exclusion
Exclusion Criteria:
Other active malignancies within 5 years or concomitantly
Have uncontrolled cardiac clinical symptoms or diseases, such as: (1) in accordancewith: New York Heart Association (NYHA) criteria grade II or greater cardiacinsufficiency or Cardiac ultrasonography: LVEF (left ventricular ejection fraction) <50%; (2) Instability Stereotyped angina; (3) Myocardial infarction within 1 yearprior to the start of study treatment Die; (4) Clinically significantsupraventricular or ventricular arrhythmias requiring treatment or intervention: (5)QTc>450ms (male); QTc>470ms (Women) (The QTc interval is calculated by Fridericia'sformula; If the QTc is abnormal, interval can be used Approximately 2 minutes forthree consecutive tests, taking the average);
Those who have high blood pressure and cannot be reduced to the normal range byantihypertensive drug treatment (admitted Systolic blood pressure ≥140mmHg ordiastolic blood pressure ≥90mmHg) (based on 2 measurements of ≥ The mean of the BPreadings obtained), which is allowed to be achieved through the use ofantihypertensive therapy above parameters
Coagulation abnormalities (INR>1.5×ULN, APTT>1.5×ULN), with: Bleeding tendency
Active bleeding
Uncontrolled active infection, chronic infectious disease, immunodeficiency syndrome
Subjects with known active hepatitis B (HBsAg positive and HBV DNA ≥10 3 copy numberor ≥1000 U/ml)
Presence of active autoimmune disease or history of autoimmune disease with possiblerecurrence 9. Known history of severe allergy to the study drug
Uncontrolled infection at screening
Other patients who are considered by the treating physician to be unsuitable forinclusion
Study Design
Study Description
Connect with a study center
Shanghai General Hospital
Shanghai, Shanghai 200040
ChinaActive - Recruiting

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