Study of Irinotecan Liposome Injection-containing Regimens Versus Nab-paclitaxel Plus Gemcitabine… (NCT05047991) | Clinical Trial Compass
UnknownPhase 2
Study of Irinotecan Liposome Injection-containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma
153 participantsStarted 2021-10
Plain-language summary
This is a multicenter, randomized, open-lable, parallel-controlled phase II study of irinotecan liposome injection-containing regimens versus nab-paclitaxel plus gemcitabine in patients with previously untreated, metastatic pancreatic adenocarcinoma. The purpose of this study is to evaluate the differences of safety and efficacy of irinotecan liposome injection-containing regimens versus nab-paclitaxel plus gemcitabine in patients with previously untreated, metastatic pancreatic adenocarcinoma.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Age 18 to 70 years old (inclusive), regardless of gender;
✓. Histologically or cytologically confirmed unresectable, locally advanced, or metastatic pancreatic adenocarcinoma;
✓. At least one measurable lesion according to RECIST 1.1.
✓. No prior systemic anti-tumor therapy, except those with disease progression more than 6 months after adjuvant therapy or neoadjuvant therapy;
✓. Patients with prior local treatment (radical radiotherapy or radical chemoradiotherapy, etc.) may be enrolled provided that the local treatment does not involve the target lesion, or the target lesion is within the treatment area, but the size has increased more than 20% since the post-treatment evaluation, and also must be completed at least 4 weeks before the first administration of the study drug, palliative decompensated radiotherapy (such as bone metastases) must be completed at least 2 weeks before the first administration of the study drug;
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
✓. Life expectancy \>3 months;
✓. Adverse reactions must recover to grade 1 or baseline according to CTCAE 5.0 (except for toxicity such as alopecia, grade 2 or less sensory neuropathy, etc., which have been judged no safety risk by investigators).
Exclusion criteria
✕. Patients with acinar cell carcinoma, pancreatoblastoma, solid pseudopapillary tumor and pancreatic neuroendocrine tumor;
✕
What they're measuring
1
Progression-Free Survival (PFS)
Timeframe: Up to twelve months after the last patient's first administration
. Patients with definitive diagnosis of CNS metastasis;
✕. Patients with hepatic encephalopathy at screening;
✕. Patients with clinically symptomatic ascites requiring puncture or drainage or who have received ascites drainage within the past 3 months, except for those with only a small amount of ascites on imaging but no clinical symptoms;
✕. Uncontrolled third lacunar effusion other than ascites (e.g., large pleural or pericardial effusion) within 4 weeks before the first administration of the test drug;
✕. Previous malignancies in the past five years (except radically resected and non-recurring basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder carcinoma, local prostate carcinoma, carcinoma in situ of cervical, or other carcinoma in situ);
✕. Patients with partial or complete biliary obstruction who has not relieved by active treatment;
✕. History of serious cardiovascular disease, including but not limited to: