Liposomal irinotecan plus oxaliplatin and 5‑FU/LV versus nab‑paclitaxel plus gemcitabine for first‑line metastatic pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, open‑label, multicenter Phase III trial comparing a liposomal irinotecan combination (irinotecan liposome + oxaliplatin + 5‑FU/LV) to nab‑paclitaxel plus gemcitabine as first‑line therapy for metastatic pancreatic cancer. Participants are randomized to one of the two chemotherapy regimens and followed for efficacy and safety outcomes, including tumor response and survival. Key eligibility includes ECOG performance status 0–1, histologically confirmed pancreatic cancer with at least one measurable lesion per RECIST 1.1, no prior metastatic treatment, and life expectancy ≥3 months. The trial is sponsored by Jiangsu HengRui and is being conducted at Peking Union Medical College Hospital in Beijing; it is open‑label so treatment assignments are known to clinicians and participants.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. ECOG performance status 0 or 1
2. Histological or cytologically confirmed pancreatic cancer that has not been previously treated in the metastatic disease.
3. Life expectancy of greater than or equal to3 months.
4. At least one measurable lesion is present according to the efficacy evaluation criteria for pancreatic cancer (RECIST 1.1)
5. Able and willing to provide a written informed consent

Exclusion Criteria:

1. Patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor;
2. Known history of central nervous system (CNS) metastases.
3. 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;
4. 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.

Where it's running

• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Zengquan Gu
• Email: zengquan.gu@hengrui.com
• Phone: 0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.