ArticleBMC medicine2025
Phase 1 trial of HR070803 (an Irinotecan liposome) in combination with 5-fluorouracil, leucovorin, and oxaliplatin for untreated advanced or metastatic pancreatic ductal adenocarcinoma.
Article in BMC medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04796948 (A Phase I Study to Evaluate the Safety and Tolerability of Irinotecan Liposome in Combination With Oxaliplatin and 5-FU/LV in the Treatment of Advanced Pancreatic Cancer), which is not on this map. Cited by 1 paper.
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A Phase I Study to Evaluate the Safety and Tolerability of Irinotecan Liposome in Combination With Oxaliplatin and 5-FU/LV in the Treatment of Advanced Pancreatic Cancer
Who cites it
1 citing paper in PubMed.
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24 authors.
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Abstract
backgroundThis study assessed the safety, preliminary antitumor activity, and pharmacokinetics of HR070803 (a novel liposomal irinotecan) in combination with 5-FU/LV and oxaliplatin for treatment-naive patients with unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC).
methodsThis multicenter, open-label, single-arm, dose-escalation phase 1 study recruited treatment-naive patients aged 18-70 years with unresectable locally advanced or metastatic PDAC. Treatment doses were escalated from 40/60 (HR070803 40 mg/m
resultsA total of 41 patients were enrolled, including 6, 17, and 18 patients in the 40/60, 60/60, and 60/85 group, respectively. Only one patient in the 60/60 group experienced dose-limiting toxicities of grade 3 increased alanine aminotransferase and grade 3 increased aspartate aminotransferase, and the MTD was not reached. Adverse events of grade ≥ 3 were reported in 31 (75.6%) patients, with the most common being decreased neutrophil count and increased gamma-glutamyltransferase. No treatment discontinuation occurred owing to adverse events, and there were no treatment-related deaths. The overall response (complete or partial response) rate was 29.3% in the total population. Pharmacokinetic results demonstrated prolonged circulation and slow release of free irinotecan.
conclusionsHR070803 plus 5-FU/LV and oxaliplatin demonstrated an acceptable toxicity, good antitumor activity, and favorable pharmacokinetic profile as a first-line treatment for patients with unresectable locally advanced or metastatic PDAC. Based on the comprehensive data obtained during the dose escalation and dose expansion stages, HR070803 60 mg/m
trial registrationClinical trials.gov NCT04796948; registered March 15, 2021.
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