Liposomal Irinotecan + Oxaliplatin + Bevacizumab Versus Liposomal Irinotecan + 5-FU/LV

Purpose of the study Phase I study: to explore the optimal dose combination of irinotecan liposome + oxaliplatin + bevacizumab regimen, irinotecan liposome + oxaliplatin Phase II study: to evaluate the safety and efficacy of the second-line treatment regimen of irinotecan liposome combined with oxaliplatin and bevacizumab compared to the second-line treatment regimen of irinotecan liposome combined with 5-FU/LV in advanced pancreatic cancer Sample size 138 cases Phase I Crawl, sample size 9-18 cases. Phase II randomized controlled clinical study, historical data NAPOLI-1 study, ORR of 8.8% for

Trial Details

NCT ID
NCT06782685
Phase
PHASE1 / PHASE2
Sponsor
Dai, Guanghai
Status
RECRUITING
Cancer Type
Pancreatic Cancer
Interventions
  • Irinotecan liposoma
  • oxaliplatin
  • bevacizumab
  • 5-FU
  • LV
  • Irinotecan Liposomal
Locations (sample)
  • Beijing, China|39.9075,116.39723
  • Beijing, China|39.9075,116.39723

Key Eligibility Criteria

  • Age 18 to 75 years old;
  • Patients with pancreatic cancer diagnosed by histopathology or cytology;
  • Unresectable disease assessed by multidisciplinary and imaging;
  • Subjects who have received prior failed first-line therapy, and recurrence within 6 months of the end of (neo)adjuvant therapy is considered a firs…

For full eligibility, visit ClinicalTrials.gov.

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