Irinotecan Hydrochloride Liposome Injection (II)in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Metastatic Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Irinotecan Hydrochloride Liposome Injection (II); Oxaliplatin; 5Fluorouracil; Calcium folinate, nab-paclitaxel; gemcitabine.
- Who it may be relevant to
- Registry conditions: First-line Treatment of Metastatic Pancreatic Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Irinotecan Hydrochloride Liposome Injection (II) in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate Versus Nab-paclitaxel in Combination With Gemcitabine for First-line Treatment of Metastatic Pancreatic Cancer: an Open, Randomized, Multicenter Phase III Trial.
Overview
This study is a randomized, open-label, multicenter Phase III clinical trial designed to evaluate the efficacy and safety of Irinotecan Hydrochloride Liposome Injection (II) combined with oxaliplatin and 5-FU/LV versus nab-paclitaxel combined with gemcitabine as first-line treatment for advanced pancreatic cancer.
Interventions
- Drug Irinotecan Hydrochloride Liposome Injection (II); Oxaliplatin; 5Fluorouracil; Calcium folinate
Irinotecan Hydrochloride Liposome Injection (II) in combination with oxaliplatin, 5-fluorouracil, calcium folinate - Drug nab-paclitaxel; gemcitabine
nab-paclitaxel in combination with gemcitabine
Primary outcome measures
- Overall survival (OS) [Time frame: From study start until target OS events have occurred (approximately 18 months after last patient enrollment)]
Secondary outcome measures (4)
- Objective Response rate (ORR) [Time frame: up to 6 months following the date the last patient was randomized]
- Disease Control Rate [Time frame: up to 6 months following the date the last patient was randomized]
- Duration of Response [Time frame: up to 6 months following the date the last patient was randomized]
- Progression free survival (PFS) [Time frame: From the date of first dose of study drug until progressive disease (PD), death, whichever occurs first,assessed up to 18 months]
Eligibility criteria
Inclusion criteria
- ECOG performance status 0 or 1
- Histological or cytologically confirmed pancreatic cancer that has not been previously treated in the metastatic disease.
- Life expectancy of greater than or equal to3 months.
- At least one measurable lesion is present according to the efficacy evaluation criteria for pancreatic cancer (RECIST 1.1)
- Able and willing to provide a written informed consent
Exclusion criteria
- Patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor;
- Known history of central nervous system (CNS) metastases.
- Severe infection (> CTCAE grade 2), such as severe pneumonia, bacteremia, infection complications, etc. requiring inpatient treatment, occurred within four weeks before enrollment, and symptoms and signs of infection requiring intravenous antibiotic therapy (except for prophylactic antibiotics) occurred within two weeks before enrollment;
- Patients with cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Patients with NYHA class 2 and above cardiac failure; (2) unstable angina; (3) myocardial infarction that occurred within 6 months; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT07238283 · HR070803-308