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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University

About this trial

This is a prospective, single-arm Phase 2 study to evaluate the efficacy and safety of Irinotecan Liposome injection combined with S-1 in patients with recurrent (unable to local curative treatment) or metastatic NPC who failed at least first-line anti-PD-1/L1.

Eligibility criteria

Qualifiers

1. Willing to participate in the study, sign the informed consent form (ICF), and comply with study plan visits, treatment plans, laboratory tests, and other study procedures.

Disqualifiers

1. Severe allergy to Irinotecan liposome (such as systemic rash/erythema hypotension, bronchospasm, angioedema, or anaphylaxis).

Trial design

Treatments tested in this trial

  • Irinotecan liposome
  • S-1

Treatment groups

56 Participants
are divided into 1 treatment group

Sponsors and collaborators

Sun Yat-sen University

Lead sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

Sponsor institution