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

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.

This study tests whether a liposomal irinotecan combination (with oxaliplatin and 5‑FU/LV) works better than nab‑paclitaxel plus gemcitabine as first‑line treatment for people with metastatic pancreatic cancer.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 662 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07238283 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with histologically confirmed metastatic pancreatic ductal adenocarcinoma who have not received prior metastatic therapy, have ECOG 0–1, at least one measurable lesion by RECIST 1.1, and a life expectancy of at least three months are the intended candidates.

Not a fit: Patients with non‑ductal pancreatic tumors (such as neuroendocrine carcinoma, acinar cell carcinoma, pancreatoblastoma, or solid‑pseudopapillary tumor), known CNS metastases, recent severe infection, poor performance status, or prior metastatic treatment are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If successful, this could provide a more effective or better‑tolerated first‑line chemotherapy option that improves tumor response and possibly survival compared with the current nab‑paclitaxel plus gemcitabine regimen.

How similar studies have performed: Liposomal irinotecan combined with 5‑FU/LV has demonstrated benefit in the second‑line setting (for example, nal‑IRI in NAPOLI‑1), but direct first‑line comparisons against nab‑paclitaxel/gemcitabine are limited.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

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

Study contacts

• Study coordinator: Zengquan Gu

Conditions First-line Treatment of Metastatic Pancreatic Cancer