Phase
Condition
Digestive System Neoplasms
Treatment
Oxaliplatin
LV
bevacizumab
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18 to 75 years old;
Patients with pancreatic cancer diagnosed by histopathology or cytology;
Unresectable disease assessed by multidisciplinary and imaging;
Subjects who have received prior failed first-line therapy, and recurrence within 6months of the end of (neo)adjuvant therapy is considered a first-line treatmentfailure;
Subjects who have not received platinum-containing or irinotecan drugs for priorfirst-line therapy;
Patients with at least one evaluable lesion according to RECIST v1.1;
ECOG score of 0-2;
Expected survival ≥ 3 months;
Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10^9/L, hemoglobin ≥90g/dL, platelets (PLT) ≥100×10^9/L, and white blood cells (WBC) ≥3.0×10^9/L;
Liver function: alanine aminotransferase (ALT), alanine aminotransferase (AST),alkaline phosphatase (ALP) ≤2.5 times the upper limit of normal (ULN), or ≤5×ULN ifliver metastases are present, total bilirubin<1.5 ULN;
Renal function: serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance (CCr) ≥60mL/min (according to the Cockcroft-Gault formula);
Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5 × ULN;
Patients with biliary obstruction should receive adequate biliary drainage; and
Adverse reactions arising from prior therapy must be restored to grade 1 or baselineaccording to CTCAE 5.0 (with the exception of toxicities such as alopecia, grade 2or lower peripheral neuropathy, which can be enrolled with no safety risk in thejudgment of the investigator);
Non-pregnant or lactating females; females/males of childbearing potential shoulduse effective contraception during the study and for 6 months after completion ofstudy treatment;
Patients are compliant, understand the study procedures, and sign a written informedconsent form.
Exclusion
Exclusion Criteria:
Patients who have had other malignant tumors within the previous 5 years (exceptcured carcinoma in situ and basal cell carcinoma of the skin);
Uncontrollable pleural effusion or ascites;
Any known brain metastasis or meningeal metastasis;
Concomitant use of a potent CYP3A4 inducer within 3 weeks prior to the first dose,or concurrent use of a potent CYP3A4 inhibitor or potent UGT1A1 inhibitor within 3weeks prior to the first dose;
Patients undergoing major organ surgery (except needle biopsy, central venouscatheterization, port catheterization, stent placement for relief of biliaryobstruction, percutaneous hepato-biliary drainage, cholecystostomy) or electivesurgical procedures scheduled within 4 weeks prior to the first dose of study drug;
Systemically treated active, uncontrolled bacterial, viral, or fungal infections,defined as persistent signs/symptoms associated with the infection that do notimprove despite appropriate antibiotics, antiviral therapy, and/or other treatments;
Subjects with congenital or acquired immunodeficiency, such as HIV-infectedindividuals or active hepatitis (transaminases do not meet the inclusion criteria,Hepatitis B : HBV DNA ≥ 1000 IU/ml; Hepatitis C : HCV RNA ≥ 1000 IU/ml); chronichepatitis B viral carriers, with HBV DNA < 2000 IU/ml, who must be concurrentlyreceiving antiviral during the trial period treatment before enrollment;
Presence of serious concomitant diseases: those with diabetes mellitus that cannotbe well controlled by glucose-lowering drugs, difficult-to-control hypertension,severe cardiovascular and cerebral vascular disease, renal failure, hepatic failure,uncontrolled epilepsy, central nervous system disease or history of mentaldisorders, those with a clear tendency to gastrointestinal bleeding, intestinalparalysis, intestinal obstruction, etc;
>grade 1 diarrhea with an increase in the number of bowel movements >4 times per daycompared to baseline; moderate to severe increase in stoma discharge; limitedinstrumental activities of daily living or even limited spontaneous activities ofdaily living; life-threatening; requiring urgent treatment;
Those with serum albumin ≤ 3 g/dL;
Those who had participated in other clinical studies within 4 weeks prior toenrollment;
Patients assessed by the investigator to be unsuitable for participation in thetrial.
Study Design
Connect with a study center
Beijing
Beijing,
ChinaSite Not Available
Chinese PLA General Hospital
Beijing,
ChinaActive - Recruiting
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