Liposomal Irinotecan + Oxaliplatin + Bevacizumab Versus Liposomal Irinotecan + 5-FU/LV

Launched by DAI, GUANGHAI · Jan 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new combination of treatments for patients with advanced pancreatic cancer who have not responded to their first line of therapy. The researchers want to find out the best dose of a combination of three drugs: liposomal irinotecan, oxaliplatin, and bevacizumab. They will compare this combination to another treatment that includes liposomal irinotecan combined with 5-FU and leucovorin (LV). The goal is to see which treatment works better and is safer for patients.

To participate in this trial, patients need to be between 18 and 75 years old and have been diagnosed with pancreatic cancer that cannot be surgically removed. They should have already tried one type of treatment that didn’t work. Participants will receive the study drugs through an intravenous (IV) infusion every two weeks and will be monitored for any side effects or changes in their condition. If you or a loved one are considering joining this trial, it’s important to discuss it with your healthcare provider to see if it’s a good option based on your individual health situation.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 to 75 years old;
• • 2. Patients with pancreatic cancer diagnosed by histopathology or cytology;
• • 3. Unresectable disease assessed by multidisciplinary and imaging;
• • 4. Subjects who have received prior failed first-line therapy, and recurrence within 6 months of the end of (neo)adjuvant therapy is considered a first-line treatment failure;
• • 5. Subjects who have not received platinum-containing or irinotecan drugs for prior first-line therapy;
• • 6. Patients with at least one evaluable lesion according to RECIST v1.1;
• • 7. ECOG score of 0-2;
• • 8. Expected survival ≥ 3 months;
• • 9. Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10\^9/L, hemoglobin ≥90 g/dL, platelets (PLT) ≥100×10\^9/L, and white blood cells (WBC) ≥3.0×10\^9/L;
• • 10. Liver function: alanine aminotransferase (ALT), alanine aminotransferase (AST), alkaline phosphatase (ALP) ≤2.5 times the upper limit of normal (ULN), or ≤5×ULN if liver metastases are present, total bilirubin\<1.5 ULN;
• • 11. Renal function: serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance (CCr) ≥60 mL/min (according to the Cockcroft-Gault formula);
• • 12. Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5 × ULN;
• • 13. Patients with biliary obstruction should receive adequate biliary drainage; and
• • 14. Adverse reactions arising from prior therapy must be restored to grade 1 or baseline according to CTCAE 5.0 (with the exception of toxicities such as alopecia, grade 2 or lower peripheral neuropathy, which can be enrolled with no safety risk in the judgment of the investigator);
• • 15. Non-pregnant or lactating females; females/males of childbearing potential should use effective contraception during the study and for 6 months after completion of study treatment;
• • 16. Patients are compliant, understand the study procedures, and sign a written informed consent form.
• Exclusion Criteria:
• • 1. Patients who have had other malignant tumors within the previous 5 years (except cured carcinoma in situ and basal cell carcinoma of the skin);
• • 2. Uncontrollable pleural effusion or ascites;
• • 3. Any known brain metastasis or meningeal metastasis;
• • 4. 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 3 weeks prior to the first dose;
• • 5. Patients undergoing major organ surgery (except needle biopsy, central venous catheterization, port catheterization, stent placement for relief of biliary obstruction, percutaneous hepato-biliary drainage, cholecystostomy) or elective surgical procedures scheduled within 4 weeks prior to the first dose of study drug;
• • 6. Systemically treated active, uncontrolled bacterial, viral, or fungal infections, defined as persistent signs/symptoms associated with the infection that do not improve despite appropriate antibiotics, antiviral therapy, and/or other treatments;
• • 7. Subjects with congenital or acquired immunodeficiency, such as HIV-infected individuals or active hepatitis (transaminases do not meet the inclusion criteria, Hepatitis B : HBV DNA ≥ 1000 IU/ml; Hepatitis C : HCV RNA ≥ 1000 IU/ml); chronic hepatitis B viral carriers, with HBV DNA \< 2000 IU/ml, who must be concurrently receiving antiviral during the trial period treatment before enrollment;
• • 8. Presence of serious concomitant diseases: those with diabetes mellitus that cannot be 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 mental disorders, those with a clear tendency to gastrointestinal bleeding, intestinal paralysis, intestinal obstruction, etc;
• • 9. \>grade 1 diarrhea with an increase in the number of bowel movements \>4 times per day compared to baseline; moderate to severe increase in stoma discharge; limited instrumental activities of daily living or even limited spontaneous activities of daily living; life-threatening; requiring urgent treatment;
• • 10. Those with serum albumin ≤ 3 g/dL;
• • 11. Those who had participated in other clinical studies within 4 weeks prior to enrollment;
• • 12. Patients assessed by the investigator to be unsuitable for participation in the trial.