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Compares treatment options for Advanced Pancreatic Cancer (Part 1)
Official title Liposomal Irinotecan + Oxaliplatin + Bevacizumab Versus Liposomal Irinotecan + 5-FU/LV
ClinicalTrials.gov ID: NCT06782685
What this study is testing
What is Irinotecan liposoma?
Irinotecan liposoma is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced pancreatic cancer (part 1).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Purpose of the study Phase I study: to explore the optimal dose combination of irinotecan liposome + oxaliplatin + bevacizumab regimen, irinotecan liposome + oxaliplatin Phase II study: to evaluate the safety and efficacy of the second-line treatment regimen of irinotecan liposome combined with oxaliplatin and bevacizumab compared to the second-line treatment regimen of irinotecan liposome combined with 5-FU/LV in advanced pancreatic cancer Sample size 138 cases Phase I Crawl, sample size 9-18 cases. Phase II randomized controlled clinical study, historical data NAPOLI-1 study, ORR of 8.8% for irinotecan liposome + 5-FU/LV, planned trial arm ORR upgrade to 25%, calculated at 60 cases in each arm.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age 18 to 75 years old;
- Patients with pancreatic cancer diagnosed by histopathology or cytology;
- Unresectable disease assessed by multidisciplinary and imaging;
- people who have received prior failed first-line therapy, and recurrence within 6 months of the end of (neo)adjuvant therapy is considered a...
- people who have not received platinum-containing or irinotecan drugs for prior first-line therapy;
You likely can't join if
- Patients who have had other malignant tumors within the previous 5 years (except cured 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...
- Patients undergoing major organ surgery (except needle biopsy, central venous catheterization, port catheterization, stent placement for relief of...
- Systemically treated active, uncontrolled bacterial, viral, or fungal infections, defined as persistent signs/symptoms associated with the infection...
See the full eligibility criteria
- Age 18 to 75 years old;
- Patients with pancreatic cancer diagnosed by histopathology or cytology;
- Unresectable disease assessed by multidisciplinary and imaging;
- people 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;
- people who have not received platinum-containing or irinotecan drugs for prior first-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 ≥90 g/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 if liver metastases are present, total bilirubin\<1.5 ULN;
- Renal function: serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance (CCr) ≥60 mL/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 baseline according to CTCAE 5.0 (with the exception of toxicities such as alopecia, grade 2 or lower peripheral neuropathy, which can be...
- 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;
- Patients are compliant, understand the study procedures, and sign a written informed consent form.
- Patients who have had other malignant tumors within the previous 5 years (except cured 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 3 weeks prior to the first dose;
- Patients undergoing major organ surgery (except needle biopsy, central venous catheterization, port catheterization, stent placement for relief of biliary obstruction, percutaneous hepato-biliary drainage...
- 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...
- people 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 ≥...
- 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...
- \>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...
- Those with serum albumin ≤ 3 g/dL;
- Those who had participated in other clinical studies within 4 weeks prior to enrollment;
- Patients assessed by the investigator to be unsuitable for participation in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.