Status:
RECRUITING
Adebelimab Combined With Irinotecan Liposomal Injection, Oxaliplatin, Fluorouracil and Calcium Folinate Are Used in the First-line Treatment of Pancreatic Cancer Liver Metastasis Efficacy and Safety
Lead Sponsor:
Jiang Long
Conditions:
Pancreatic Cancer Metastatic to Liver
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
1. Evaluation of adebelimab in combination with irinotecan liposomes, oxaliplatin, fluorouracil, efficacy and safety of leucovorin in the first-line treatment of advanced metastatic pancreatic cancer ...
Detailed Description
Pancreatic cancer is a cancer of the digestive system with a very high degree of malignancy and a very poor prognosis. In recent years, morbidity and death. The rate shows a clear upward trend at home...
Eligibility Criteria
Inclusion
- 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 previous treatment 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 to initiation of study treatment days): (1) Routine blood examination: (No blood transfusion and no use of granules within 14 days before screening.) Cell colony-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 (no transfusion 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, ALT and AST≤5×ULN； 3) Blood creatinine \[Cr\]≤1×ULN or endogenous creatinine clearance rate \> 50ml/min (Cockcroft-Gault formula); (3) International normalized ratio \[INR\] ≤ 2.3 or prothrombin time \[PT\] exceeding Over the range of normal controls≤6 seconds: (4) Urine protein \< 2+ (if urine protein ≥ 2+, you can urinate eggs for 24 hours White quantitative, 24-hour urine protein quantification \<1.0g can be enrolled);
- Women of childbearing potential must have a pregnancy test (serum or urine) within 7 days prior to enrollment The result is negative and voluntarily during the observation period and after the last dose of study drug8 Use of appropriate methods of contraception within a week; For males, it should be surgically sterile, or Agrees to adopt appropriate during the observation period and for 8 weeks after the last dose of study drug method contraception
- Those who are expected to have good compliance can follow up the efficacy and adverse reactions according to the requirements of the protocol.
Exclusion
- Other active malignancies within 5 years or concomitantly
- Have uncontrolled cardiac clinical symptoms or diseases, such as: (1) in accordance with: New York Heart Association (NYHA) criteria grade II or greater cardiac insufficiency or Cardiac ultrasonography: LVEF (left ventricular ejection fraction) \<50%; (2) Instability Stereotyped angina; (3) Myocardial infarction within 1 year prior to the start of study treatment Die; (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention: (5) QTc\>450ms (male); QTc\>470ms (Women) (The QTc interval is calculated by Fridericia's formula; If the QTc is abnormal, interval can be used Approximately 2 minutes for three consecutive tests, taking the average);
- Those who have high blood pressure and cannot be reduced to the normal range by antihypertensive drug treatment (admitted Systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg) (based on 2 measurements of ≥ The mean of the BP readings obtained), which is allowed to be achieved through the use of antihypertensive 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 number or ≥1000 U/ml)
- Presence of active autoimmune disease or history of autoimmune disease with possible recurrence 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 for inclusion
Key Trial Info
Start Date :
July 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06531278
Start Date
July 16 2024
End Date
December 31 2026
Last Update
July 31 2024
Active Locations (1)
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1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200040