Efficacy and Safety of Irinotecan Liposome Combined with S-1 in PD-1/L1 Inhibitor Refractory Recurrent or Metastatic Nasopharyngeal Carcinoma A Prospective, Single-Arm Phase 2 Study

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Irinotecan Liposome injection combined with S-1 in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have not responded to at least first-line anti-PD-1/L1 therapy. This Phase 2, single-arm study focuses on patients with NPC that cannot be treated with local curative methods. The study aims to assess treatment effects and tolerability in this specific patient group over approximately one year. Participants will receive up to 6 cycles of Irinotecan Liposome injection at 50 mg/m2 on days 1 and 15 via intravenous infusion every 4 weeks, combined with oral S-1 taken twice daily from days 1 to 14 every 4 weeks. Dosing of S-1 is adjusted based on body surface area. Treatment will continue until disease progression, unacceptable side effects, withdrawal of consent, initiation of new cancer therapy, loss to follow-up, death, or study completion, whichever occurs first. During the study, patients will have regular visits that include imaging scans to monitor tumor response and evaluate safety. Researchers will measure the objective response rate over about one year. Participants' organ functions and side effects will be closely monitored to ensure safety. The total duration of involvement depends on individual patient outcomes and study timelines.

Irinotecan Liposome Combined with S-1 in PD-1/L1 Inhibitor Refractory Recurrent or Metastatic NPC